FDA Approves Bemotrizinol for Use in U.S. Sunscreens
The FDA approved bemotrizinol, a UV filter used in Europe and Asia for more than 20 years. The approval marks the first new sunscreen ingredient cleared in the United States since 1999. New products containing the ingredient are not expected for over a year.
Bemotrizinol absorbs both UVA and UVB rays and remains stable when exposed to sunlight. It has been an ingredient in sunscreens sold in Europe and Asia for more than 20 years.
First new filter since 1999 The FDA classifies sunscreens as over-the-counter drugs, requiring each active ingredient to complete a lengthy review. No new UV filter had been approved since 1999. Dermatologist Ellen Gendler said U.S. sunscreens block UVB rays effectively but rely on a single approved UVA ingredient, avobenzone, which she described as unstable.
Differences in regulation and texture Other countries classify sunscreens as cosmetics, allowing faster approval of new filters. Products sold in those markets often provide broader UVA protection and apply with less white residue. Gendler said patients using U.S. sunscreens with high SPF ratings sometimes still tan because of limited UVA coverage.
Timeline for new products DSM Nutritional Products submitted the application for bemotrizinol. The company and manufacturers will need additional time to formulate, test, and distribute products containing the new filter. Consumers seeking sunscreens with bemotrizinol will continue to rely on imported products for at least another year.
