Congress Advances Sunscreen Reform to Strengthen Skin Cancer Prevention
Congress passed long-awaited sunscreen reform legislation that modernizes the U.S. Food and Drug Administration’s (FDA) outdated review process and will help expand Americans’ access to safe, effective, and innovative sunscreen ingredients widely used around the world. The SAFE Sunscreen Standards Act (H.R. 3686) was signed into law on November 13, 2025, and marks a significant step forward in strengthening the nation’s skin cancer prevention efforts amid rising rates of melanoma and other skin cancers.
The new law allows the FDA to consider real-world evidence, non-animal testing data, and other modern scientific methods when evaluating ultraviolet (UV) filters for approval. It also pauses pending administrative orders until they can be reviewed under these updated standards and directs the agency to issue implementation guidance within one year. Together, these changes remove longstanding regulatory barriers that have prevented new sunscreen ingredients from reaching U.S. consumers for more than two decades.
ASDSA coordinated advocacy efforts for a broad coalition of dermatologic and patient advocacy organizations to advance these reforms. Through direct Capitol Hill meetings, coordinated coalition letters, and ongoing engagement with federal policymakers, ASDSA worked to keep skin cancer prevention and patient safety a key priority of congressional action and build the bipartisan support needed to move the legislation across the finish line.
Following passage of the reform, the FDA has finalized the addition of bemotrizinol as a new sunscreen active ingredient – the first new ingredient added to the OTC sunscreen monograph in more than 20 years. According to the FDA, bemotrizinol provides protection against both UVA and UVB radiation, has low levels of absorption through the skin into the body, and is considered generally recognized as safe and effective (GRASE) for use in adults and children six months of age and older. The ingredient has been used in sunscreen products available internationally for many years and was approved for use in sunscreen formulations at concentrations up to six percent. This addition represents an early example of how the updated framework can accelerate access to modern sun protection options.