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FDA Announces Draft Guidance for OTC Sunscreens

December 17, 2015

UNITED STATES - The U.S. Food and Drug Administration (FDA) has released draft guidance for over-the-counter (OTC) sunscreens that specifies the FDA’s opinion regarding the safety and effectiveness and the data needed to determine a non-prescription sunscreen’s active ingredient or combination of active ingredients. The draft guidance also includes an FDA approach to safety-related final formulation testing for possible future adoption.

The release of the draft guidance is in partial implementation of the SIA (Pub. L. 113-195), enacted November 26, 2014, which amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

The draft guidance is open for public consultation until January 22, 2016.


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