Sunscreen Innovation Act (SIA)
On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (Public Law No. 116-136, 134 Stat. 281, 457) was signed into law. Section 505G of the CARES Act reforms and modernizes the OTC drug review process. It also includes provisions that sunsetted the Sunscreen Innovation Act at the end of fiscal year 2022.
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.
Public Communication
- FDA Voice Blog: FDA's Sunscreen Guidance outlines safety and effectiveness data needed for new active ingredients
- From our perspective: Helping to Ensure the safety and effectiveness of sunscreens
Implementing the SIA
Meetings
Additional Background Information
- FDA Voice Blog: Shedding some light on FDA's review of sunscreen ingredients and the Sunscreen Innovation Act
- Rulemaking History for OTC Sunscreen Drug Products
- Consumer Information on Sunscreen