Congress Advances Sunscreen Reform to Strengthen Skin Cancer Prevention
Congress has passed long-awaited sunscreen reform legislation that modernizes the U.S. Food and Drug Administration’s (FDA) outdated review process and will help expand Americans’ access to safe, effective, and innovative sunscreen ingredients widely used around the world.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 proposed adding bemotrizinol as a new sunscreen active ingredient – the first proposed addition in more than 20 years. Bemotrizinol offers broad-spectrum UVA/UVB protection, low systemic absorption, and a strong safety profile, and is already used in sunscreens available internationally. This proposal represents an early example of how the updated framework can accelerate access to modern sun protection options.
Surgeon General Call to Action
Amid rising skin cancer rates, in July 2014, U.S. Surgeon General Dr. Boris Lushniak released a critical call to action for all Americans to combat skin cancer. The call to action declared skin cancer a public health crisis in the face of staggering statistics showing that nearly 5 million people were treated for skin cancer in the U.S. each year at an estimated cost of 8.1 billion dollars. In response, to combat one of the largest contributors to skin cancer rates at the time, key legislators and public health officials worked to educate the public on indoor tanning’s threats and implement policy measures that protected minors. The efforts successfully helped to reduce skin cancer rates associated with the practice of indoor tanning but even with this progress more than a decade later, skin cancer remains the most common cancer in the U.S.
ASDSA urges the U.S. Surgeon General to renew the Call to Action to Prevent Skin Cancer and develop a plan that will spur meaningful progress in addressing skin cancer.