Skip to main content
  • Feature Story

FDA Announces Draft Guidance for OTC Sunscreens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UNITED STATES - The U.S. Food and Drug Administration (FDA) has released draft guidance for over-the-counter (OTC) sunscreens that specifies the FDA’s opinion regarding the safety and effectiveness and the data needed to determine a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 The draft guidance also includes an FDA approach to safety-related final formulation testing for possible future adoption.

The release of the draft guidance is in partial implementation of the SIA (Pub.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The draft guidance is open for public consultation until January 22, 2016.

Source

Get in touch

Have questions, need specifics? Let's get this conversation started.

Help and support

How can we help?