Department of Health and Human Service May 2018 – Federal Register Recent Federal Regulation Documents

Enforcement Policy-Over-the-Counter Sunscreen Drug Products Marketed Without an Approved Application; Guidance for Industry; Availability
Document Number: 2018-10994
Type: Notice
Date: 2018-05-23
Agency: Food and Drug Administration, Department of Health and Human Services, Department of Health and Human Service
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Enforcement PolicyOTC Sunscreen Drug Products Marketed Without an Approved Application.'' This guidance describes FDA's approach to enforcement for over-the-counter (OTC) sunscreen products marketed without approved applications before a final OTC sunscreen drug monograph becomes effective. This guidance finalizes the draft guidance of the same name issued June 17, 2011.