US EditionFDA proposes allowing sunscreen ingredient already used in Europe and Asia
Bemotrizinol offers broad-spectrum UVA/UVB protection, is photostable, has low skin absorption, and is safe for children 6 months and older, FDA said in a Dec. 11 proposal.
- On December 11, 2025, the U.S. Food and Drug Administration proposed adding bemotrizinol as a permitted sunscreen active ingredient that protects against UVA and UVB and is more photostable than many filters.
- The United States currently approves 16 main sunscreen filters compared with about 30 in Europe, and the last new ingredient was added in 1999, with the FDA acknowledging slow progress.
- DSM Nutritional Products LLC submitted an OTC Monograph Order Request to add bemotrizinol at concentrations up to 6 percent, and the FDA proposed the change through the OTC monograph administrative order process, seeking public comment.
- If finalized, the ingredient would be considered safe for adults and children 6 months and older; Ben Nichols, FDA spokesman, said the agency expects a final order next summer or fall with products sold by late 2026.
- Dermatologists and formulators say bemotrizinol is photostable and less irritating, enabling lighter textures and improving tolerance for sensitive skin.
70 Articles
70 Articles
FDA Poised to Allow a Big Sunscreen Improvement
American sunscreen options may soon look a lot more like what's already on shelves in Europe and Australia. The Food and Drug Administration on Thursday proposed allowing bemotrizinol, an ultraviolet filter widely used overseas, to be added to the list of active ingredients US sunscreen makers can use. Dermatologists say...
US proposes major change to sunscreen regulations
A new proposal from the US Food and Drug administration would allow sunscreens in the US to include an active ingredient already commonly used in Australia, Europe, and parts of Asia.Bemotrizinol is a chemical that provides broad-spectrum protection against both ultraviolet A and B rays. It "has low levels of absorption through the skin into the body, and rarely causes skin irritation," the FDA said in a news release today.The FDA regulates the …
FDA Proposes Allowing Sunscreen Ingredient Used in Other Countries
The Food and Drug Administration announced on Dec. 11 that it has formally proposed letting companies add bemotrizinol to sunscreen. Data show the light filter protects against ultraviolet rays, is only absorbed into the body through the skin at low levels, and rarely causes skin irritation, the FDA said in its proposed order. That includes data from clinical studies involving healthy adults, the FDA said in a scientific review of bemotrizinol’s…
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