Guidance, Compliance & Regulatory Information > Sunscreen Innovation Act (SIA)

Guidance, Compliance & Regulatory Information > Sunscreen Innovation Act (SIA)

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.

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

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

• Regulatory Policy Information

Meetings

• Sunscreen meetings

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.

• 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 Rulemaking History for OTC Sunscreen Drug Products
• Consumer Information on Sunscreen This page provided consumer information about sunscreen and sun protection. It goes into the topics of SPF, ingredients, how to use properly, and other topics. Videos are also provided.

Contact FDA

Toll Free

(855) 543-3784, or

(301) 796-3400

druginfo@fda.hhs.gov

Human Drug Information

Division of Drug Information (CDER)

Office of Communications

Feedback Form

10001 New Hampshire Avenue

Hillandale Building, 4th Floor

Silver Spring, MD 20993