FDA Adds Bemotrizinol at Up to 6% in First New Sunscreen Ingredient Approval in 20 Years
Updated
Updated · FDA.gov · Jun 9
FDA Adds Bemotrizinol at Up to 6% in First New Sunscreen Ingredient Approval in 20 Years
3 articles · Updated · FDA.gov · Jun 9
Summary
Bemotrizinol can now be used in U.S. over-the-counter sunscreens for adults and children 6 months and older after the FDA finalized its order Tuesday.
The ingredient protects against both UVA and UVB rays, has low skin absorption, and the FDA deemed it generally recognized as safe and effective.
DSM Nutritional Products sought the change, asking to add bemotrizinol at concentrations up to 6% through the OTC monograph process rather than a separate drug application.
The FDA moved from proposed order to final action in 7 months, making bemotrizinol the first new sunscreen active ingredient added under the streamlined CARES Act framework.
Used in Europe for decades, bemotrizinol's addition narrows a long-standing gap with overseas sunscreen markets and could increase competition in U.S. products.
After a 25-year wait, will this new ingredient finally make Americans enjoy using sunscreen?
The U.S. approved a filter Europe has used for decades. Is the global sunscreen gap finally closing?
Bemotrizinol Approved by FDA: How a New UV Filter Will Transform U.S. Sunscreen Options and Public Health
Overview
On June 9, 2026, the FDA approved bemotrizinol as a new over-the-counter sunscreen ingredient, marking a major milestone for sun protection in the U.S. This approval, made possible by an updated regulatory framework, allows bemotrizinol to enter the American market after years of international use and expert anticipation. Recognized as safe and effective, bemotrizinol offers important advantages over existing sunscreens, including better efficacy and safety. The FDA’s rigorous standards ensure consumers can trust these new products, and the streamlined process helps bring innovative sun protection options to the public more efficiently than before.