Drugs

Sunscreen Innovation Act (SIA)

The Sunscreen Innovation Act (SIA) was enacted on November 26, 2014 to provide an alternative process for the review of safety and effectiveness of nonprescription sunscreen active ingredients.

The SIA supplements the FDA’s Time and Extent Application (TEA) regulation with new statutory procedures. The SIA also requires FDA to establish timeframes for review of TEAs for OTC drugs other than sunscreen active ingredients.

Implementing the SIA

Includes SIA statutory deadlines, FDA’s progress in meeting them, and links to published regulatory materials

Additional Background Information

  • On September 4-5, 2014, the Nonprescription Drugs Advisory Committee discussed the scope of safety testing that should be required for sunscreen active ingredients to be marketed in U.S. over-the-counter (OTC) sunscreen products.

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Page Last Updated: 11/22/2016
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