SAFE Sunscreen Standards Act

This bill updates how the FDA reviews over-the-counter skin products, like sunscreen and other creams. It lets the FDA use real-world evidence, not just traditional clinical trials, to judge if active ingredients in topical products are safe and work well. It also pushes the FDA to consider non-animal testing methods and to issue guidance within one year on how companies can use these alternatives for topical drugs .

For sunscreen, the FDA’s final rules must consider past safety data on ingredients already used in the U.S., recognize the role of broad spectrum SPF 15+ sunscreens in preventing skin cancer, and include the updated evidence and testing standards. The Department of Health and Human Services must report on progress within 18 months and then yearly for five years, and post those reports online within a week so the public can see what’s happening .

• Who is affected: Consumers using sunscreen and other over-the-counter skin products; companies that make these products; the FDA.
• What changes: More flexible evidence (including real-world data), encouragement of non-animal testing, sunscreen rules that reflect proven cancer prevention benefits and past safety data, and public reporting on progress .
• When: FDA guidance on non-animal testing due within 1 year; first public progress report due in 18 months, then annually for 5 years .