Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use, 35620-35665 [2011-14766]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 76, Number 117 (Friday, June 17, 2011)]
[Rules and Regulations]
[Pages 35620-35665]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-14766]



[[Page 35619]]

Vol. 76

Friday,

No. 117

June 17, 2011

Part IV





Department of Health and Human Services





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Food and Drug Administration





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21 CFR Parts 201, 310, and 352





Sunscreen Drug Products for Over-the-Counter Human Use; Final Rules and 
Proposed Rules

Federal Register / Vol. 76 , No. 117 / Friday, June 17, 2011 / Rules 
and Regulations

[[Page 35620]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201 and 310

[Docket No. FDA-1978-N-0018] (Formerly Docket No. 1978N-0038)
RIN 0910-AF43


Labeling and Effectiveness Testing; Sunscreen Drug Products for 
Over-the-Counter Human Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing this 
document to address labeling and effectiveness testing for certain 
over-the counter (OTC) sunscreen products containing specified active 
ingredients and marketed without approved applications. This document 
addresses labeling and effectiveness testing issues raised by the 
nearly 2,900 submissions that we received in response to the sunscreen 
proposed rule of August 27, 2007 (2007 proposed rule). The document 
also identifies specific claims that render a product that is subject 
to this rule misbranded or would not be allowed on any OTC sunscreen 
product marketed without an approved application. The document does not 
address issues related to sunscreen active ingredients or certain other 
issues regarding the GRASE determination for sunscreen products. The 
document requires OTC sunscreen products to comply with the content and 
format requirements for OTC drug labeling contained in the 1999 Drug 
Facts final rule (published in the Federal Register of March 17, 1999, 
by lifting the delay of implementation date for that rule that we 
published on September 3, 2004).

DATES: Effective Date: This final rule is effective June 18, 2012. For 
additional information concerning this effective date, see section X in 
the preamble of this document. The incorporation by reference of a 
certain publication listed in this rule is approved by the Director of 
the Federal Register as of June 18, 2012.
    Compliance Date: The compliance date for all products subject to 
this final rule with annual sales less than $25,000 is June 17, 2013. 
The compliance date for all other products subject to this final rule 
is June 18, 2012.
    Implementation date: FDA is lifting the delay of implementation 
date for Sec.  201.66 as published at 69 FR 53801, September 3, 2004.

FOR FURTHER INFORMATION CONTACT: Reynold Tan, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 5411, Silver Spring, MD 20993, 301-796-
2090.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Overview of Document
    A. Rulemaking History
    B. Scope of This Document
    C. Issues Outside the Scope of This Document
    D. Enforcement Policy
    E. Summary of Major Revisions to the Labeling and Testing 
Requirements Included in the 2007 Proposed Rule
II. Administrative and Other Issues
III. Principal Display Panel (PDP) Labeling
    A. SPF Statement
    B. Broad Spectrum Statement
    C. Water Resistance Statement
    D. UVB and UVA Educational Statement
IV. Drug Facts Labeling
    A. Active Ingredients/Purpose
    B. Uses
    C. Warnings
    D. Directions
    E. Constitutionality of Labeling Statements Regarding Skin 
Cancer and Skin Aging
    F. Other Information
    G. Reduced Labeling
V. Miscellaneous Labeling Outside Drug Facts
VI. SPF Test Parameters
    A. Solar Simulator
    B. Sunscreen Standards
    C. Test Subjects
    D. Test Sites and Subsites
    E. Finger Cot
    F. Application Amount
    G. Water Resistance
VII. SPF Test Issues (Other Than Test Parameters)
    A. Pass/Fail (Binomial) SPF Test
    B. Photostability
    C. In Vitro SPF Test
    D. Anti-Inflammatory Ingredients
VIII. Broad Spectrum Test
    A. In Vivo Test Method: Not Required
    B. In Vitro Test Method: Critical Wavelength
    C. Critical Wavelength Test Parameters
IX. Analysis of Impacts
    A. Final Regulatory Impact Analysis
    B. Small Business Impact (Final Regulatory Flexibility Analysis)
X. Paperwork Reduction Act of 1995
XI. Environmental Impact
XII. Federalism
XIII. References

I. Overview of Document

A. Rulemaking History

    This section of the document does not discuss every regulatory 
action associated with OTC sunscreen products. It highlights the major 
regulatory actions that are related to the regulatory actions being 
taken in this document. For a complete list of all regulatory actions 
associated with OTC sunscreen products, please refer to our Web site: 
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Over-the-CounterOTCDrugs/StatusofOTCRulemakings/ucm072134.htm.
    In the Federal Register of May 12, 1993 (58 FR 28194), we published 
a proposed rule for OTC sunscreen products that identified active 
ingredients we tentatively considered to be generally recognized as 
safe and effective (GRASE), as well as associated labeling and sun 
protection factor (SPF) testing to be required for these OTC sunscreen 
products (the 1993 proposed rule). The SPF test and corresponding 
labeling reflect the level of protection against sunburn, which is 
caused primarily by UVB radiation. The 1993 proposed rule also 
explained the importance of protection against UVA radiation (58 FR 
28194 at 28232 and 28233). The proposed rule referenced published UVA 
test methods but did not propose a specific method (58 FR 28194 at 
28248 to 28250). Rather, the proposed rule stated that a sunscreen 
product could be labeled as ``broad spectrum,'' or labeled with a 
similar statement, if it protected against UVA radiation as 
demonstrated by one of the published UVA tests or a similar test.
    In April 1994, we reopened the administrative record to allow 
additional submissions concerning UVA-related issues. We also announced 
a public meeting to be held in May 1994 to discuss UVA testing 
procedures (59 FR 16042, April 5, 1994). We held the public meeting to 
gather more information to help us determine the most appropriate UVA 
test method and labeling.
    In November 1997, Congress enacted the Food and Drug Administration 
Modernization Act of 1997 (FDAMA), which addressed OTC sunscreen 
products among other FDA issues. Section 129 of FDAMA stated that ``not 
later than 18 months after the date of enactment of this Act, the 
Secretary of Health and Human Services shall issue regulations for 
over-the-counter sunscreen products for the prevention or treatment of 
sunburn.'' We then determined that the GRASE active ingredients, SPF 
testing requirements, and related labeling were issues that we could 
finalize within the timeframe set by FDAMA. Because we had not 
previously proposed specific UVA testing and labeling requirements, we 
did not have sufficient time to finalize these UVA requirements within 
the FDAMA timeframe.
    In the Federal Register of May 21, 1999, we published a final rule 
for OTC

[[Page 35621]]

sunscreen products (64 FR 27666). The 1999 sunscreen final rule added 
the sunscreen monograph (regulations) in part 352 (21 CFR part 352) and 
included an effective date of May 2001. The 1999 sunscreen final rule 
stated that we would publish a proposed rule outlining UVA testing and 
labeling requirements at a future date. In 2000, we extended the 
effective date for the 1999 sunscreen final rule to December 2002 (65 
FR 36319, June 8, 2000).
    In December 2001, we stayed the December 2002 effective date of the 
1999 sunscreen final rule indefinitely. We took this action because we 
planned to revise part 352 to add UVA testing and labeling requirements 
so that OTC sunscreen products would be tested and labeled for both UVB 
and UVA radiation protection. We included these revisions in a proposed 
rule that published in the Federal Register of August 27, 2007 (72 FR 
49070). The 2007 proposed rule identified UVA testing and labeling that 
we proposed should be required for all OTC sunscreen products. The 
proposed rule also revised SPF testing and corresponding labeling from 
the 1999 final rule. The proposed rule did not lift the existing stay 
of the effective date for part 352.
    On September 3, 2004 (69 FR 53801), we delayed until further notice 
the implementation date for the Drug Facts final rule (64 FR 13254, 
March 17, 1999) (21 CFR 201.66) for OTC sunscreen products. The Drug 
Facts final rule (21 CFR 201.66) establishes general labeling format 
and content requirements for all OTC drugs. We explained that we 
postponed the implementation date for general Drug Facts labeling 
requirements for sunscreens because we did not expect to issue the 
sunscreen final rule containing UVA testing and product-specific 
labeling requirements (i.e., this document) by the Drug Facts 
implementation date of May 2005. Therefore, we delayed the 
implementation date until further notice to prevent sunscreen product 
manufacturers from having to relabel their products at two closely 
related time intervals, as initially required by the 1999 Drug Facts 
final rule and the 1999 sunscreen final rule.

B. Scope of This Document

    This final rule establishes the labeling and testing requirements 
for OTC sunscreen products containing specific ingredients or 
combinations of ingredients and marketed without an approved 
application under section 505 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355) (the FD&C Act). The requirements in this final rule 
will help ensure that these currently marketed sunscreen products are 
appropriately labeled and tested for both UVA and UVB protection. In 
addition, the requirements in this final rule will help ensure the 
proper use of these sunscreens and greater consumer protection from the 
damaging effects of UV radiation. This final rule also identifies 
claims that render a product that is subject to this rule misbranded or 
are not allowed on any OTC sunscreen drug product marketed without an 
approved application.
    As described in the previous section of this document, we issued 
the 2007 proposed rule as a proposed amendment to the sunscreen 
monograph requirements in 21 CFR part 352 primarily to establish UVA 
testing and labeling requirements so that all OTC sunscreen products 
marketed under the sunscreen monograph would be tested and labeled for 
both UVB and UVA radiation protection. Sunscreen active ingredients, 
UVB testing, UVB labeling, and other conditions under which sunscreens 
would be considered GRASE and not misbranded had been addressed in the 
1999 (stayed) final rule. In response to the 2007 proposed rule, 
however, we received submissions from the public concerning all aspects 
of the sunscreen monograph (i.e., the conditions specified in the 1999 
final rule and the 2007 proposed rule). As discussed further in this 
section, some of the issues regarding the monograph conditions raised 
in the public submissions will require further evaluation by us. 
Therefore, we are not issuing a final monograph with GRASE conditions 
for sunscreens in this document. Instead, we are publishing this final 
rule establishing labeling and the effectiveness testing upon which it 
relies, which applies to the same sunscreens that were the subject of 
the 2007 proposed rule to amend the monograph, because it is in the 
best interest of public health to publish this final rule while we work 
on remaining issues that need to be addressed in order to publish a 
final monograph. This labeling will help ensure that these products are 
not misbranded by providing specific indications, directions, warnings, 
and other important information to help consumers select and use them 
appropriately.
    In this final rule, then, we are codifying in 21 CFR part 201 
requirements for OTC sunscreen products containing specified active 
ingredients and marketed without approved applications under section 
505 of the FD&C Act (21 U.S.C. 355) (hereafter referred to as 
``covered'' products). With respect to these covered products, this new 
section 21 CFR 201.327 includes requirements for labeling and the 
effectiveness testing upon which it relies. Because we have not yet 
resolved all of the issues regarding conditions under which sunscreens 
are GRASE and not misbranded, the stay of 21 CFR part 352 remains in 
effect. Although we are not yet codifying these labeling and related 
effectiveness testing provisions in the monograph regulation, they do 
embody the agency's current determination on appropriate regulation of 
these aspects of sunscreens that were previously identified as falling 
within the monograph in part 352, and supersede the prior approach 
embodied in the never-effective provisions of 21 CFR part 352 subparts 
C and D. While this rule does not lift the stay of part 352, we are 
lifting the delay of implementation date for the Drug Facts labeling 
requirements of 21 CFR 201.66. In addition, this rule codifies certain 
specific claims that render a covered product misbranded or are not 
allowed on any OTC sunscreen drug product marketed in the United States 
without an approved application.
    We note that all provisions of new 21 CFR 201.327 and the 
amendments to 310.545 included in this rule apply only to the 
aforementioned covered products, and references in this document to 
``covered'' products recognize this limitation. Manufacturers of 
sunscreen products that are already being marketed pursuant to an 
approved application can contact FDA's Center for Drug Evaluation and 
Research to discuss supplemental submissions that would enable them to 
include labeling on their products like that specified in this final 
rule.

C. Issues Outside the Scope of This Document

    There are a number of issues that were raised in public submissions 
responding to the 2007 proposed rule that are outside the scope of this 
document. The issues fall into two categories:
     GRASE determination for sunscreen products and active 
ingredients
     Issues affecting multiple OTC drug monographs

As explained below, in this document, we are not addressing these 
issues related to determining the GRASE status of sunscreen products or 
sunscreen active ingredients and are not addressing the issues 
described below affecting multiple OTC drug monographs.

[[Page 35622]]

1. Issues Regarding GRASE Determination for Sunscreen Products and 
Active Ingredients
    A large number of submissions on the 2007 proposed rule raised 
issues related to the conditions that define what constitutes a GRASE 
finished OTC sunscreen product, irrespective of its active ingredients. 
These included over 1000 submissions requesting that we limit the 
monograph to sunscreens that offer broad spectrum protection and have 
SPF values of 15 or higher. Because this final rule is a labeling rule, 
and not a monograph, we do not address these issues here but plan to 
address them in future rulemakings regarding the monograph and 
conditions for general recognition of safety and effectiveness.
    This rule also does not address issues related to the GRASE status 
of sunscreen active ingredients that are included in the 2007 proposed 
rule (proposed 21 CFR 352.10 and 352.20). We received 20 submissions 
raising questions about the safety of ingredients in sunscreens (Ref. 
1). Ten of the submissions specifically asked that we ensure that none 
of the ingredients are carcinogenic. Others asked that we ensure that 
all ingredients in sunscreens are safe without citing a specific 
concern. We intend to address carcinogenicity and other safety 
considerations related to sunscreen active ingredients in a future 
rulemaking.
    We also received submissions requesting that we increase the GRASE 
concentration of avobenzone from 3 percent to 5 percent (Ref. 1). 
Another submission points out that there are two USP \1\ monographs for 
zinc oxide:
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    \1\ United States Pharmacopeia.
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     Zinc oxide (Ref. 2)
     Zinc oxide neutral (Ref. 3)

The submission would like us to clarify that zinc oxide in OTC 
sunscreen products can meet the specifications of either USP monograph 
(Ref. 1). We intend to address all of these issues regarding GRASE 
determination for sunscreen active ingredients in future rulemakings.
    In addition, we received two submissions requesting that we 
classify three new ingredients not previously marketed in the United 
States as GRASE: bemotrizinol, bisoctrizole, and octyl triazone (Ref. 
1). We found these active ingredients eligible for review under the OTC 
drug monograph system in 2003 (octyl triazone) and 2005 (bemotrizinol 
and bisoctrizole) (68 FR 41386, July 11, 2003, and 70 FR 72449, 
December 5, 2005). We are currently reviewing the safety and 
effectiveness data submitted for these and other sunscreen active 
ingredients found eligible for potential addition to the monograph. 
When we complete our review, we will issue proposed rules stating our 
tentative conclusions on the safety and effectiveness of all of these 
ingredients.
2. Issues Affecting Multiple OTC Drug Monographs
    This final rule also does not address three issues raised in 
response to the 2007 sunscreen proposed rule that are not specific to 
sunscreen products. Because these issues apply more generally to 
multiple categories of OTC drug products, we are not addressing these 
issues in this final rule, which is limited to OTC sunscreen products.
    The first issue concerns the inclusion of expiration dates on 
sunscreen labels. We received 12 submissions requesting that we require 
OTC sunscreen products to be labeled with an expiration date (Ref. 1). 
Currently, regulations in 21 CFR 211.137(h) do not require that an 
expiration date be included in labeling if an OTC drug product does not 
have any dosage limitations and is stable for at least 3 years. This 
regulation applies to many OTC drug products, including sunscreen 
products. Any modification of the existing regulations would require 
publication of a proposed rule addressing all OTC drug products 
affected by the expiration date regulations.
    The second issue concerns the term ``final monograph.'' One 
submission argued that we should not use this term because it is 
inaccurate (Ref. 1). As the submission states, ``FDA is to continually 
evaluate products, so nothing is ever finalized.'' This issue applies 
to monographs representing all categories of OTC drug products. 
Therefore, we are not addressing the issue in this document.
    The third issue concerns the country of origin listing for all 
ingredients (i.e., both active and inactive ingredients) on a sunscreen 
drug product. We received a submission requesting that we provide the 
country of origin for each ingredient. The submission also requested 
that manufacturers be required to provide specific details about what 
each ingredient does in the product. This issue applies to all OTC drug 
products and, therefore, we are not addressing it in this document.

D. Enforcement Policy

    As noted, no final monograph is currently in effect for OTC 
sunscreen drug products, and in its absence, questions may arise 
regarding FDA's enforcement policy for OTC sunscreen products marketed 
without approved applications. To clarify expectations for industry, 
elsewhere in this issue of the Federal Register, we are announcing the 
availability of a draft guidance document, explaining the agency's 
intended enforcement policy for these products until a final sunscreen 
monograph becomes effective.

E. Summary of Major Revisions to the Labeling and Effectiveness Testing 
Included in the 2007 Proposed Rule

    In response to the 2007 proposed rule, we received almost 2,900 
submissions from the public. Of these submissions, over 2,500 expressed 
general support for the proposed rule and urged us to finalize and 
implement the new rule quickly. Three hundred twenty-five of the 
submissions raised approximately 90 specific issues related to the 
proposed rule. We have addressed the issues specifically relating to 
labeling and effectiveness testing in this final rule. Based on the 
submissions received, and the information and data included in those 
submissions or otherwise available to us, we have re-evaluated our 
position on several issues in the 2007 proposed rule and made several 
changes to our proposed labeling and testing requirements. Tables 1, 2, 
4, and 5 in this document summarize the labeling and effectiveness 
testing requirements included in the 2007 proposed rule as well as the 
labeling and effectiveness testing required by this final rule:
     Table 1: PDP Labeling (discussed in section III)
     Table 2: Drug Facts Labeling (discussed in section IV)
     Table 4: SPF Test (discussed in section VI)
     Table 5: Broad Spectrum Test (discussed in section VIII)

Rather than summarizing all of the revisions to the labeling and 
testing included in the 2007 proposed rule, we are highlighting what we 
consider to be the most important revisions in this section of the 
document.

    We made the following changes to the proposed labeling:
    1. The proposed UVA ``star rating'' is not required on the PDP.
    2. A combined ``Broad Spectrum SPF'' statement is required on the 
PDP for sunscreen products that pass the broad spectrum test 
established in new 21 CFR 201.327(j). To pass the broad spectrum test, 
the amount of UVA protection must increase as the SPF value increases.
    3. For sunscreen products that pass the broad spectrum test 
established in new 21 CFR 201.327(j) and have SPF

[[Page 35623]]

values of 15 or higher in accordance with the SPF test in 21 CFR 
201.327(i):
    a. The ``Sun Alert'' warning proposed as the first warning in 2007 
is not required (Warning proposed located in 21 CFR 352.52(c)(1)).
    b. A new indication statement may be included to inform consumers 
that using the product ``as directed with other sun protection measures 
(see Directions [in bold italic font]) decreases the risk of skin 
cancer and early skin aging caused by the sun.''
    c. A new direction statement has been added informing consumers 
that exposure to the sun increases the risk of skin cancer and early 
skin aging and providing a list of specific sun protection measures 
that can decrease this risk.
    4. For any OTC sunscreen product that does not pass the broad 
spectrum test in 21 CFR 201.327(j), or that are broad spectrum with an 
SPF value less than 15, this final rule, like the 2007 proposed rule, 
requires that the first warning indicate the adverse consequences of 
spending time in the sun. The wording of this warning has been revised 
to state, ``Skin Cancer/Skin Aging Alert [in bold font]: Spending time 
in the sun increases your risk of skin cancer and early skin aging. 
This product has been shown only to help prevent sunburn, not [in bold 
font] skin cancer or early skin aging.''
    We also made the following changes to the effectiveness testing 
proposed in 2007:
    1. The number of subjects required in the SPF test has been reduced 
from 20 subjects to 10 subjects.
    2. One in vitro test is required to demonstrate broad spectrum 
protection rather than the two previously proposed tests (an in vitro 
test and an in vivo test).
    3. The broad spectrum test is a pass/fail test based on the 
critical wavelength value of 370 nm \2\.
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    \2\ Nanometers.
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II. Administrative and Other Issues

    Some of the submissions that we received following publication of 
the 2007 proposed rule made the following requests involving 
administrative issues (Ref. 1):
     Extend the comment period of the 2007 proposed rule.
     Lift the stay on 21 CFR part 352, imposed in 2001 (66 FR 
67485).
     Allow interim marketing of products containing avobenzone 
with ensulizole and avobenzone with zinc oxide.
     Set an effective date for this final rule other than the 
18 months proposed in the 2007 proposed rule.
     Revise the preemption language included in the 2007 
proposed rule by deleting any references regarding the rule's potential 
preemption of State tort law.

Our positions on these issues are discussed in the remainder of this 
section of the document.
    All of the requests to extend the comment period were submitted 
before the November 28, 2007 Federal Register notice in which we 
extended the comment period of the 2007 proposed rule (72 FR 67264). In 
that notice, we extended the close of the comment period from November 
26, 2007, to December 26, 2007. We have not received any more requests 
to extend the comment period since December 2007.
    With regard to requests to lift the stay of 21 CFR part 352 (the 
OTC sunscreen monograph), as already discussed, our 2007 proposed rule 
anticipated amending the testing and labeling provisions of that 
monograph and subsequently lifting the stay. However, comments received 
on the 2007 proposed rule not only addressed labeling and effectiveness 
testing for final sunscreen formulations, but also raised other issues 
about the monograph conditions for OTC sunscreen products that require 
further consideration. As a result, we are not finalizing amendments to 
part 352 at this time nor lifting the stay placed on that section as 
enacted in 1999 (66 FR 67485). Rather, this final rule establishes in 
21 CFR 201.327 labeling requirements and the effectiveness testing upon 
which it relies for covered OTC sunscreen drug products. We intend to 
lift the stay on part 352 when we reach our final conclusions on the 
conditions under which sunscreen products are GRASE and not misbranded, 
including a determination regarding sunscreen active ingredients, and 
publish a revised final monograph. In the interim, the labeling and 
effectiveness testing provisions of this rule apply to covered OTC 
sunscreen products.
    We received a request that we allow interim marketing of avobenzone 
combinations in proposed Sec.  352.20(a)(2) prior to issuing a final 
rule for part 352. Subject to our enforcement discretion, we will 
continue to allow the marketing of avobenzone combinations provided for 
in the 1999 sunscreen final rule. However, we are not allowing 
marketing of the additional avobenzone combinations discussed in the 
2007 proposed rule until we reach a final conclusion on the GRASE 
determination for sunscreen active ingredients and combinations of 
those ingredients.
    We are requiring that this final rule become effective in 1 year, 
even though we considered 18 months in the 2007 proposed rule (72 FR 
49070 at 49110). We are allowing products with annual sales less than 
$25,000 to comply with this rule in 2 years, as stated in the 2007 
proposed rule. In response to the proposed rule, we received one 
submission arguing that we should require this final rule to become 
effective in 1 year (Ref. 1). The submission stated that a later 
effective date would have a negative public health impact. We received 
eight submissions arguing that we should extend the effective date from 
the proposed 18 months to 3 years (Ref. 1). The submissions listed the 
following reasons for allowing more than 18 months:
     Repackaging
     Relabeling
     Testing/retesting
     Removing products from market
     Impact on small businesses

The most common argument was that more time would be needed to test/
retest OTC sunscreen products for broad spectrum protection in 
accordance with both the in vitro and in vivo UVA test methods included 
in the proposed rule.

    We agree with the submission which stated that it would be 
beneficial for consumers to have this rule become effective within 1 
year. As explained in section VIII.A of this document, we are not 
requiring manufacturers to demonstrate broad spectrum protection by 
conducting in vivo and in vitro tests. This final rule requires that 
manufacturers conduct only the simpler and less expensive nonclinical 
in vitro test to demonstrate broad spectrum protection. In vitro tests 
are substantially shorter than in vivo tests. Therefore, we are setting 
an effective date for this rule 1 year from the date of publication in 
the Federal Register. However, we are providing two years for all 
products with annual sales less than $25,000 to comply with this rule. 
In addition, in order to ensure that limited testing laboratory 
capacity does not result in sunscreen shortages during the transition 
to the new rule, we intend to exercise enforcement discretion for a 
period of time with regard to the SPF test for certain OTC sunscreen 
products on the market by June 17, 2011 (see our draft guidance 
entitled ``Guidance for Industry: Enforcement Policy--OTC Sunscreen 
Drug Products Marketed Without An Approved Application'' announced 
elsewhere in this issue of the Federal Register).
    The submissions stating that additional time is necessary for

[[Page 35624]]

repackaging and relabeling did not submit any information or data to 
support these arguments (Ref. 1). The argument that more than 18 months 
is needed to remove non-compliant products from the market is not 
valid. In the 2007 proposed rule, we indicated that sunscreen products 
which are already distributed by the effective date of the final rule 
would not be expected to be relabeled or retested in conformity with 
the final rule conditions unless these products were subsequently 
relabeled or repackaged after the effective date (72 FR 49070 at 
49109). Consistent with this statement, we do not expect non-compliant 
products introduced or delivered for introduction into interstate 
commerce prior to the compliance dates specified for this final rule to 
be removed from the market.
    We received a submission that expressed concern about the agency's 
preemption discussion in the 2007 proposed rule (72 FR 49070 at 49109 
and 49110) and requested that we delete any discussion regarding the 
rule's potential preemption of State tort law (Ref. 1). The submission 
claimed that we exceeded our authority when we stated that section 
751(a) of the FD&C Act displaces both State legislative requirements 
and State common law duties. The submission argued that Congress 
intended to preserve State common law claims by including section 
51(e), which exempts State product liability claims from express 
preemption under section 751(a) of the FD&C Act. The commenter appears 
to have construed our statement in a way that would nullify section 
751(e) of the FD&C Act. We did not intend to suggest that section 
751(a) of the FD&C Act preempts State product liability claims, whether 
based on State legislative enactments or common law, because section 
751(e) exempts such actions from the express preemption provision in 
section 751(a). However, it is important to note that section 751(e) of 
the FD&C Act exempts only those common law claims that are based on 
State product liability law. Our revised preemption discussion in 
section XII remains consistent with applicable law.
    The submission also requested that we delete any references to 
implied preemption. In this final rule, we have omitted any statement 
regarding implied preemption because, although implied preemption may 
arise, such scenarios are necessarily case-specific. Section XII of 
this document makes clear that the sole statutory provision giving 
preemptive effect to the final rule is section 751 of the FD&C Act.

III. Principal Display Panel (PDP) Labeling

    In response to the 2007 sunscreen proposed rule, we received 45 
submissions requesting that we revise the proposed principal display 
panel (PDP) labeling (Ref. 1). We are revising the PDP labeling based, 
in part, on these submissions (see table 1 of this document). We have 
decided that the PDP labeling included in this document will simplify 
the purchase decision for consumers by allowing them to more easily 
find important information included on the PDP.

  Table 1--Summary of PDP Labeling in the 2007 Proposed Rule and This Final Rule Using a Broad Spectrum SPF 30
 Water Resistant Sunscreen Product as Example A and an SPF 6 Sunscreen That Is Not Broad Spectrum and Not Water
                                             Resistant as Example B
----------------------------------------------------------------------------------------------------------------
         Labeled information                       2007 Proposed rule                     This final rule
----------------------------------------------------------------------------------------------------------------
Effectiveness Rating \1\.............  Example A:                                  Example A:
                                       ``UVB SPF 30 High''                         ``Broad Spectrum SPF 30''
                                       ``UVA [starf][starf][starf][star14] High''
                                       Example B:                                  Example B:
                                       ``UVB SPF 6 Low''                           ``SPF 6''
                                       ``No UVA Protection''
Water Resistance.....................  Example A:                                  Example A:
                                       ``Water Resistant''                         ``Water Resistant (40
                                                                                    minutes)''
                                       Example B:                                  Example B:
                                       No statement on water resistance            No statement on water
                                                                                    resistance
Educational Statement................  Examples A & B:                             Examples A & B:
                                       ``UV rays from the sun are made of UVB and  No educational statement
                                        UVA. It is important to protect against
                                        both UVA and UVB rays.''
----------------------------------------------------------------------------------------------------------------
\1\ The UVA rating in the 2007 proposed rule is a four-tier rating (low, medium, high, highest). The UVA testing
  in this final rule is pass/fail--a product is either allowed or not allowed to include a broad spectrum
  statement depending on results of the test described in new 21 CFR 201.327(j) (see section VIII of this
  document).

A. SPF Statement

    In the 2007 sunscreen proposed rule, we proposed redefining the 
acronym ``SPF'' as the ``sunburn protection factor.'' We also proposed 
that the term ``UVB SPF'' would be required on the PDP of all OTC 
sunscreen products (proposed 21 CFR 352.50(a)). This term would be 
followed by the numerical value determined from SPF testing and one of 
the following descriptors: ``low,'' ``medium,'' ``high,'' or 
``highest.'' For example, a sunscreen product could have contained the 
statement ``UVB SPF 40 High'' on the PDP.
    We received 12 submissions regarding the SPF statement in response 
to the 2007 sunscreen proposed rule (Ref. 1). Collectively, the 
submissions made the following requests:
    1. Do not change the definition of SPF to ``sunburn protection 
factor''
    2. Remove UVB from ``UVB SPF''
    3. Redefine the ``highest'' product category descriptor to include 
SPF 50
    4. Require SPF values expressed in multiples of 5
    5. Label SPF as the percent of UVB radiation screened

As discussed in the remainder of this section, we agree with the first 
and second requests, but are not granting the other three requests.

    In this final rule, unlike the 2007 proposed rule, we have no 
express definitional section. However, we identify ``SPF'' as an 
abbreviation for ``sun protection factor'' in new 21 CFR 201.327(a)(1), 
and use it consistently in this way throughout the rule. This use of 
the term SPF is identical to the definition in the 1999 stayed 
sunscreen final rule (64 FR 27666). For products that are not broad 
spectrum, the term ``SPF'' will appear on the PDP with the numerical 
SPF value calculated according to the test method in new 21

[[Page 35625]]

CFR 201.327(i). For broad spectrum sunscreen products, the term ``Broad 
Spectrum SPF'' will appear on the PDP along with the numerical SPF 
value calculated according to the test method in new 21 CFR 201.327(i).
    The term ``UVB'' will not be required as part of the SPF statement. 
We are also not requiring the descriptor (e.g., ``high'' or ``low''). 
We included these two requirements in the 2007 proposed rule because we 
had concluded that the requirements would help consumers understand the 
side-by-side SPF numerical rating in conjunction with the UVA star 
rating, which included the term ``UVA'' and the same descriptors (72 FR 
49070 at 49084). As discussed in section III.B of this document, the 
UVA star rating is not being included in this final rule, and as 
discussed below, we have concluded that neither the term ``UVB'' nor 
the descriptor is necessary for consumers to understand the 
effectiveness statement.
    Neither the term ``UVB'' nor a descriptor (e.g. ``low'' or 
``high'') had been included on sunscreen labels prior to our 2007 
proposal, and consumers had been able to make purchase and use 
decisions based on SPF values alone. Under this final rule, the SPF 
value will be expressed on the PDP by including the term ``SPF,'' 
followed by the numerical value determined from the SPF test, similar 
to how it has appeared on the labels of OTC sunscreen products for more 
than 30 years. As described in section III.B of this document, for 
products passing the critical wavelength test in new 21 CFR 201.327(j), 
the SPF value statement will be expressed as ``Broad Spectrum SPF'' 
followed by the numerical SPF value calculated according to the test 
method in 21 CFR 201.327(i).
    We received five submissions objecting to the definition of SPF as 
``sunburn protection factor'' and only one submission supporting the 
definition (Ref. 1). The submissions objecting to the definition argued 
that, if the term ``sunburn protection factor'' is used, consumers may 
mistakenly assume that a higher SPF value means a higher probability of 
sunburn. Additionally, they argued that sunscreen products protect 
against various harmful effects of sun exposure, such as early skin 
aging and skin cancer, in addition to protecting against sunburn. Some 
submissions suggested that the term ``sunburn protection factor'' will 
lead consumers with darker skin to assume that they do not need 
sunscreen products because they do not burn easily (Ref. 1).
    We agree with the arguments provided by the submissions suggesting 
that the term ``sunburn protection factor'' may be misleading. In the 
2007 sunscreen proposed rule, we revised the definition of SPF from 
``sun protection factor'' to ``sunburn protection factor'' because we 
thought that the new definition was more descriptive of what an SPF 
value represents (72 FR 49070 at 49077). The SPF value is determined 
from a clinical test with sunburn as the endpoint. However, for broad 
spectrum sunscreen products, the SPF statement also serves as a 
relative measure of the magnitude of broad spectrum protection (Ref. 
4). In this final rule, while we do not codify a separate definitional 
section, we continue to use the term ``SPF'' to mean ``sun protection 
factor,'' as we had done in the 1999 final rule (21 CFR 201.327(a)(1)).
    In this final rule, we are also revising the effectiveness 
statement so that the term ``UVB'' is not required before the term 
``SPF,'' as proposed in the 2007 proposed rule (proposed 21 CFR 
352.50(a)). We received six submissions requesting this revision (Ref. 
1). These submissions argued that ``UVB SPF'' is an incorrect 
representation of the SPF value determined from a test using a solar 
stimulator that emits both UVA and UVB radiation. The submissions point 
out that sunburn is not caused solely by UVB radiation. It is well 
known that UVA radiation contributes up to 20 percent of the skin's 
sunburn response (Refs. 5 and 6). One submission points out that if a 
sunscreen product blocked 100 percent of the incident UVB radiation and 
none of the erythemally effective UVA radiation, the sunscreen product 
would have SPF values no higher than 11 (if only 9 percent or 1/11 of 
UV radiation reaches the skin) (Ref. 4).
    We agree that UVA radiation contributes to the development of 
sunburn. Although the contribution of UVA to sunburn is less than UVB, 
it is still significant (Ref. 5). Further, as stated in the 
submissions, protection against UVA radiation is necessary to achieve 
higher SPF values (Ref. 5). We proposed including the term ``UVB'' in 
the SPF statement in the 2007 proposed rule to help consumers 
understand that the SPF effectiveness rating is different from the UVA 
effectiveness (star) rating being proposed (72 FR 49070 at 49084). 
However, as discussed elsewhere in this final rule we are not requiring 
a UVA effectiveness rating on the PDP (see section III.B.). Therefore, 
the term ``UVB'' is not necessary as part of the SPF statement. In this 
final rule, we are not requiring the term ``UVB'' be placed before the 
term ``SPF.''
    In the 2007 sunscreen proposed rule, we stated that the SPF value 
should be followed by one of the descriptors ``low,'' ``medium,'' 
``high,'' or ``highest'' (proposed 21 CFR 352.50(a)). The proposed 
descriptors were included to help consumers understand the SPF value 
because the label would have included identical descriptors for the UVA 
star rating. As discussed in section III.B. of this document, we are 
not requiring a UVA effectiveness rating on the PDP. Therefore, 
descriptors are no longer required to distinguish the SPF value from 
the UVA rating on a sunscreen label. Because we are not requiring a 
descriptor after the SPF value on the PDP in this document, the request 
to include SPF 50 sunscreen products in the ``highest'' category is no 
longer relevant.
    We received two other requests for revision to the SPF statement 
with which we do not agree. First, a submission stated that SPF values 
should only be labeled in multiples of five to be consistent with SPF 
labeling recommendations by the European Commission (Ref. 7). Second, 
one request from a submission suggested that SPF values should be 
expressed as the percent of UV absorption. The submission argued that 
the current SPF values are misleading because consumers believe an SPF 
15 sunscreen product is not very protective even though it screens 93 
percent of UV radiation.
    We do not agree with either submission. Based on SPF test data we 
have reviewed, we find that SPF values for sunscreen products generally 
can be determined with a precision that allows the products to be 
labeled with SPF values in intervals of less than 5 units (Ref. 1). 
Therefore, there is no mathematical or statistical basis for 
restricting SPF values to multiples of five. Contrary to the second 
request, consumers have relied on SPF values for over 30 years and are 
familiar with this format. Therefore, expressing SPF values as 
percentages may be confusing. It would imply that the stated percentage 
of the entire UV spectrum is absorbed by a sunscreen. However, the SPF 
values only reflect protection against the portion of the UV spectrum 
that causes sunburn. Additionally, the percentages of UV radiation 
screened that the submission notes are theoretical. The percentages are 
determined in a laboratory setting and not under actual use conditions. 
For example, laboratory tests may show that an SPF 15 sunscreen absorbs 
93 percent of UV rays, but, under actual use conditions, the level of 
protection provided by an SPF 15 sunscreen product may be significantly 
below 93 percent. There are a number of factors

[[Page 35626]]

that lead to this decreased protection, the most important being under-
application of the sunscreen product (72 FR 49070 at 49092). Therefore, 
if SPF values were expressed as percentages, consumers might mistakenly 
believe that the sunscreen products they are using provide more 
protection than they really do provide under actual use conditions.

B. Broad Spectrum Statement

    In response to the 2007 proposed rule, we received over 50 
submissions collectively making the following four requests regarding 
the UVA effectiveness rating (Ref. 1):
    1. Do not require UVA 4-star rating system.
    2. Do not require ``no UVA protection'' statement if a product does 
not protect against UVA radiation.
    3. Do not require the UVA statement to be the same size as the SPF 
statement.
    4. Perform label comprehension studies prior to implementing 
proposed PDP labeling.

The submissions included arguments, but no data, to support these 
requests.

    We agree with the first and second requests. However, we are not 
granting the third and fourth requests. Our reasons for these decisions 
are explained below, but we first summarize the related provisions of 
this final rule. We are not requiring a star rating or descriptors to 
indicate the level of UVA protection as proposed. Instead, to indicate 
the level of UVA and UVB protection, we are establishing a pass/fail 
broad spectrum test and a broad spectrum labeling statement. If a 
sunscreen product passes the broad spectrum test (see section VIII.B. 
of this document), under this final rule, the PDP of the product must 
include the statement ``Broad Spectrum SPF [insert numerical SPF value 
resulting from testing under paragraph (i) of this section],'' without 
any ``UVA'' reference (Sec.  201.327(a)(1)(i)). We are requiring the 
Broad Spectrum SPF statement to appear as continuous text with no 
intervening text or graphics. We are also requiring that the entire 
text be the same font style, size and color on the same background 
color. (Sec.  201.327(a)(1)(ii)).
    With regard to the submissions received, nearly all of the 50+ 
submissions argued against requiring the 4-star rating system to 
display the level of UVA protection on the PDP of OTC sunscreen 
products (Ref. 1). Many submissions stated that the presence of stars 
and a number (SPF) on the PDP will lead to consumer confusion. Some 
submissions argued that consumers may be confused when determining 
whether a star is filled or empty, thereby not knowing the UVA 
protection level. Other submissions argued that consumers are familiar 
with star ratings, but that the star rating for items such as movies 
and hotels are based on recommendations and not rigorous data. They 
suggested several options for labeling UVA protection, such as a 
numerical rating or another symbol other than stars.
    Some submissions suggested that the UVA rating should be 
proportional to the SPF value but requested that there not be two 
ratings on the PDP. The submissions cited the European Commission's 
recommendation that UVA protection increase as the SPF value increases 
(Ref. 7). The European Commission recommends a minimum UVA protection 
factor equal to at least one-third of the labeled SPF or a critical 
wavelength of at least 370 nm, but does not recommend that the actual 
value of the UVA protection factor or critical wavelength be displayed. 
The European Commission recommends that the main indicator of sun 
protection be the SPF value. Broad spectrum protection is indicated by 
a symbol on sunscreen labels--the acronym ``UVA'' enclosed within a 
circle the diameter of which should not exceed the height of the SPF 
value.
    We agree with the submissions that the UVA star rating would likely 
be confusing in conjunction with the numerical SPF rating. We also 
agree with the submissions requesting that UVA protection should be 
proportional to the SPF value. We are requiring such proportionality in 
the broad spectrum test described in this document. Because of this 
proportionality, there is no longer a need for a separate UVA rating. 
Instead of a rating, we are requiring a ``broad spectrum'' statement on 
the PDP if a product has a critical wavelength equal to or greater than 
370 nm. This pass/fail ``broad spectrum'' statement is consistent with 
the recommendations in the submissions citing the recommendations of 
the European Commission.
    As noted, several submissions responding to our proposal for a 
separate UVA rating with stars suggested that consumer comprehension 
testing should be performed before the proposed labeling is 
implemented. We agree with the submissions that consumer comprehension 
data can be very helpful in formulating labeling changes. In fact, in 
conjunction with our 1993 proposal to allow products to be labeled as 
``broad spectrum'' if they contained sunscreen active ingredients that 
absorbed UVA radiation (58 FR 28194 at 28233), we requested label 
comprehension study data to allow us to determine consumer 
understanding of the terms ``broad spectrum,'' ``UVA,'' and ``UVB'' (58 
FR 28194 at 28243). Unfortunately, the data we received were not 
sufficient to allow us to determine the level of consumer understanding 
of these terms (72 FR 49070 at 49081 through 49085), and we received no 
further consumer comprehension data in response to the 2007 proposal to 
require the UVA star rating. While we acknowledge the value of consumer 
comprehension data, for reasons explained below, we conclude that 
conducting consumer comprehension testing is not necessary in this case 
in light of the labeling we have selected for the final rule.
    First, submissions suggesting consumer testing were responding to 
the UVA star rating in the proposed rule, the value of which would have 
been based on the results of two tests (72 FR 49070 at 49081 through 
49085). As noted, we agree with the submissions suggesting that the 
2007 UVA labeling proposal was likely to be confusing. Elsewhere in the 
document, we also discuss our final choice of a pass-fail test for 
establishing UV protection (section VIII.B). As a result of these 
changes in the underlying test method and the submissions on the 
proposed labeling, we have incorporated a much simpler labeling 
statement in this final rule. This statement designates as ``broad 
spectrum'' those products that are demonstrated to have a critical 
wavelength of at least 370 nm, using the test in new 21 CFR 201.327(j).
    Second, unlike in 1993 when we first sought consumer data on the 
term ``broad spectrum'', and unlike the UVA star rating that we 
proposed in 2007, consumers are now likely to be familiar with the term 
``broad spectrum'' as included in this document because some sunscreen 
manufacturers have labeled sunscreen products as ``broad spectrum'' for 
over 20 years. For example, the Johnson and Johnson ``Sundown Broad 
Spectrum'' line of sunscreens was on the market in 1988 (Ref. 8). As 
already noted, in our 1993 proposed rule, we not only sought consumer 
data, but in fact proposed that products be permitted to be labeled as 
``broad spectrum'' if they contained sunscreen active ingredients that 
absorbed UVA radiation, although we did not at that time propose to 
require a specific test to demonstrate UVA protection (58 FR 28194 at 
28233). We continued to allow this statement in the 1999 sunscreen 
final rule (64 FR 27666 at 27666 through 27667).
    Many consumers may also be familiar with the term ``broad 
spectrum'' because

[[Page 35627]]

of public health campaigns and news articles about the importance of 
broad spectrum UV protection over the last two decades. For example, an 
article appearing in Working Woman magazine in 1990 urged women to 
``make sure to look for the term `broad spectrum' on the label of a 
sunscreen'' because ``it means you're getting protection from both 
types of radiation'' (Ref. 9).
    For consumers not already familiar with the term ``broad 
spectrum,'' the additional indication statement allowed in this 
document for certain broad spectrum sunscreen products should help 
consumers recognize the benefit of these products. Under ``Uses'' in 
Drug Facts, broad spectrum sunscreen products with an SPF value of 15 
or higher are allowed the following indication statement: ``if used as 
directed with other sun protection measures (see Directions [in bold 
italic font]), decreases the risk of skin cancer and early skin aging 
caused by the sun'' (new 21 CFR 201.327(c)(2)).
    In addition, educational campaigns about sun protection will 
further inform consumers about the benefits of using sunscreens that 
include the term ``broad spectrum'' on their labels and have an SPF 
value of 15 or higher. We expect consumers to learn that a sunscreen 
labeled with the statement ``Broad Spectrum SPF'' 15 or higher, when 
used as directed with other sun protection measures, offers more 
comprehensive protection against sun-induced skin damage than that 
provided by a sunscreen that is not broad spectrum or that are broad 
spectrum with an SPF value less than 15.
    It is important to note that the broad spectrum test required in 
this document captures both UVB and UVA protection for the 
effectiveness of a sunscreen product. The broad spectrum test is not 
limited to UVA wavelengths as was the case with the proposed test (see 
section VIII.B of this document). By requiring that a broad spectrum 
sunscreen provide both UVB and UVA protection in a pass/fail test, the 
amount of UVA protection for a sunscreen product that passes the test 
must increase as the SPF increases. For example, a Broad Spectrum SPF 
40 sunscreen product provides greater protection against both UVB and 
UVA than a Broad Spectrum SPF 20 sunscreen product. In contrast, an SPF 
40 sunscreen product that is not broad spectrum provides more UVB 
protection than a SPF 20 sunscreen product that is not broad spectrum, 
but may not provide more UVA protection.
    This proportionality between UVB and UVA protection is important 
because consumers have been accustomed to basing their purchase 
decision concerning protection level primarily on the SPF value, and 
only secondarily on indications of whether or not the sunscreen 
provides broad spectrum protection. For example, a consumer seeking 
lower protection may have chosen an SPF 15 sunscreen product, whereas a 
consumer seeking higher protection may have chosen an SPF 40 sunscreen 
product. By creating a clear and standardized ``yes/no'' indicator 
regarding broad spectrum protection, these final labeling requirements 
will enable consumers to make better and more informed purchase 
decisions by looking to see if a product has a ``Broad Spectrum SPF'' 
value on the label. Thus, the ultimate purchase decision would be based 
on the numerical value associated with the Broad Spectrum SPF 
statement. For products offering broad spectrum protection, the Broad 
Spectrum SPF value on the PDP will not only indicate the relative level 
of protection against UVB radiation but will also reflect the level of 
UVA protection, with increasing SPF values indicating greater 
protection against both UVA and UVB radiation. For broad spectrum 
products, linking the amount of UVA protection to the SPF value, is 
consistent with the approach taken in Europe (Ref. 7).
    For broad spectrum products, we are requiring the broad spectrum 
statement on the PDP to appear in combination with the SPF statement. 
For example, an SPF 40 sunscreen product which passes the broad 
spectrum test will be labeled ``Broad Spectrum SPF 40'' in a uniform 
font style, size, and color and with the same background color. This 
placement will help consumers recognize that the particular sunscreen 
product is broad spectrum in conjunction with the SPF value. As 
previously explained, the broad spectrum statement and SPF value 
together will provide a relative measure of both UVB and UVA 
protection. Combining the broad spectrum and SPF statements will help 
consumers become more aware of the importance of broad spectrum 
protection.
    Under the 2007 proposed rule, if an OTC sunscreen product was not 
tested for or did not protect against UVA radiation, the statement ``No 
UVA protection'' would have been required on the PDP (proposed 21 CFR 
352.50(b)(1)). Ten submissions argued against requiring this statement 
(Ref. 1). Some submissions argued that this statement is misleading 
because all sunscreen products provide some UVA protection. Submissions 
also stated that a negative statement is inconsistent with the OTC Drug 
Review because a drug should only describe the indications for which it 
is effective. Other submissions suggested that we should require all 
sunscreen products to provide UVA and UVB protection, making this 
statement unnecessary.
    We have concluded that the ``No UVA Protection'' statement is not 
necessary and could be misleading. Under this final rule, the labeling 
on the PDP of sunscreens no longer refers the type of UV radiation (UVA 
or UVB) protection offered; rather, products that pass the critical 
wavelength test in 201.327(j) are labeled with ``Broad Spectrum SPF'' 
values. Under this labeling, consumers who see ``UVA'' on the PDP, even 
if it is part of the statement ``No UVA Protection,'' may mistakenly 
believe that the product offers UVA protection. To eliminate this 
potential misunderstanding, we are not including the ``No UVA 
Protection'' statement on the PDP.
    In contrast to four submissions requesting that we make the UVA 
statement less prominent than the SPF statement, we are requiring the 
SPF and broad spectrum statements to be equally prominent on the PDP by 
appearing as a combined statement. The four submissions stated that 
they believe UVB radiation contributes more to skin cancer and 
photodamage than UVA radiation and argued that more prominence should 
be given to the SPF statement. However, none of the submissions 
included data to support this argument. Some submissions suggested that 
consumers are familiar with SPF ratings and that providing another 
rating with similar prominence may mislead and confuse consumers.
    It is well known that both UVA and UVB radiation contribute to 
photodamage and skin cancer (Refs. 6-7 and 10-12). Therefore, in our 
view, providing consumers with information about the effectiveness of a 
sunscreen product for UVA and UVB radiation protection is equally 
important. We are requiring that the broad spectrum statement be 
displayed in combination with the SPF statement. The two statements 
must not be interrupted with any graphics or text. In addition, the 
broad spectrum statement must be the same font style, size, and color 
as the SPF statement with the same background color. It is important 
for consumers to evaluate both statements when making a purchase 
decision. By requiring this information to be presented with identical 
prominence on the PDP, consumers should be able to quickly and easily 
identify sunscreen products that provide broad spectrum protection, as 
well as the SPF of all sunscreen products. While we are not requiring a 
negative statement on the

[[Page 35628]]

PDP of products that do not pass the critical wavelength test in new 
301.327(j), we caution that such products may be misbranded if they 
include statements regarding UVA protection; such statements may 
misleadingly imply that the product provides benefits that are similar 
or superior to those of products labeled with Broad Spectrum SPF 
values.

C. Water Resistance Statement

    In the 2007 sunscreen proposed rule (proposed 21 CFR 352.52), we 
allowed the PDP of OTC sunscreen products to contain the statement 
``water resistant'' if a sunscreen product was shown to retain the 
labeled SPF value after 40 minutes of water immersion, or ``very water 
resistant'' if a sunscreen product was shown to retain the labeled SPF 
value after 80 minutes of water immersion, according to the test in 
proposed 21 CFR 352.76. We simultaneously proposed that the ``Uses'' 
section of labeling (not the PDP) indicate specifically whether the 
product had been established to be water resistant for 40 minutes or 80 
minutes, and included specific directions addressing times for 
reapplication of each product, dependent on its level of water 
resistance (proposed 21 CFR 352.52(b)(1)(vii), (b)(1)(viii), (d)(2), 
and (d)(3); 72 FR 49070 at 49113). In this document, we are revising 
the PDP to contain the statement ``water resistant (40 minutes)'' or 
``water resistant (80 minutes)'' as determined by the water resistance 
test in new 21 CFR 201.327(i)(7). We are removing this information from 
the indications section of Drug Facts (section IV.B of this document). 
We continue to include directions based on the duration of water 
resistance established under the new water resistance test (section 
IV.D of this document).
    One submission stated that including information about water 
resistance in the indications section as well as in the directions 
section is ``redundant and confusing'' (Ref. 1). The submission 
recommended that we delete the indications statement. We agree with the 
submission. To eliminate redundancy and simplify the labeling for 
consumers, we are relocating the information formerly contained within 
the indication statement to the PDP.
    The content of the labeling as a whole is the same as that included 
in the 2007 proposed rule. However the proposed statement on the PDP 
did not clearly and accurately convey to consumers the difference 
between ``water resistant'' and ``very water resistant'' sunscreen 
products. For example, knowing that a sunscreen product is ``very water 
resistant'' does not give any indication of how much time a consumer 
can safely spend in the water. Under the 2007 proposed rule, a consumer 
would have had to read either the ``Uses'' or the ``Directions'' 
section of the Drug Facts label to determine the duration of water 
resistance for a sunscreen product (proposed 21 CFR 352.52(b)(1)(vii) 
and (b)(1)(viii) and proposed 21 CFR 352.52(d)(2) and (d)(3), 
respectively; 72 FR 49070 at 49113).
    Providing, on the PDP, specific information about the actual time 
(40 or 80 minutes) a consumer can expect a sunscreen product to retain 
its labeled SPF value is likely to be more helpful to consumers because 
the information is displayed in one place--on the PDP and not on 
different parts of the labeling. The revised statements ``water 
resistant (40 minutes)'' or ``water resistant (80 minutes)'' should 
make it clearer and easier for consumers to understand water resistance 
as part of their purchase decision. This water resistance information 
continues to be reinforced by information in the directions regarding 
reapplication.

D. UVB and UVA Educational Statement

    In the 2007 sunscreen proposed rule, we proposed that the following 
educational statement be included on the PDP of all OTC sunscreen 
products (proposed 21 CFR 352.50(c)): ``UV rays from the sun are made 
of UVB and UVA. It is important to protect against both UVB and UVA 
rays to prevent sunburn and other skin damage.''
    We received four submissions regarding the UVB and UVA educational 
statement in response to the 2007 sunscreen proposed rule (Ref. 1). The 
submissions made the following requests:
     Do not require the educational statement on the PDP or
     Combine the educational statement with the sun alert 
statement and include the combined statement in the ``Other 
Information'' section of the Drug Facts label.
    We considered including the proposed educational statement on the 
PDP. We concluded that this information is not critical for effective 
use of sunscreen products, particularly since we are no longer 
requiring other PDP statements to refer separately to UVA and UVB 
protection. An understanding that the sun produces ultraviolet (UV) 
rays or that there are two types of UV rays that reach the earth's 
surface is not necessary to ensure the safe and effective use of 
sunscreen products. The explanation of thes