SAFE Sunscreen Standards Act

This bill aims to get safe, effective sunscreen ingredients to store shelves faster while keeping people protected. It tells the FDA to set clear, science-based rules for judging sunscreen ingredients and to accept real-world evidence and observational studies, not just traditional clinical trials. It also pushes the FDA to use non‑animal testing methods and to publish guidance within 180 days explaining how companies can meet safety standards without animal tests.

The FDA’s final decision on pending over‑the‑counter sunscreen ingredients must consider past safe use, highlight that sunscreen helps prevent skin cancer, and follow the new evidence standards in this bill. The Department of Health and Human Services must report each year (starting within 1 year) on how these changes are working, including progress on alternatives to animal testing, and post those reports online within a week. The bill cites how common and deadly skin cancer is, and notes that no new over‑the‑counter sunscreen active ingredients have been approved since 1999, showing why a better review process is needed.

Key points

• Who is affected: Sunscreen makers, the FDA, and consumers who want effective sun protection.
• What changes: Clear FDA standards; acceptance of real‑world evidence; more use of non‑animal testing; FDA must factor in historical safety data; yearly public reports on progress .
• When: FDA guidance on non‑animal testing due within 180 days; annual reports begin within 1 year and are posted online within 7 days of submission .