The FDA has approved bemotrizinol (BEMT) as a new active ingredient for over-the-counter sunscreens, marking the first new U.S. sunscreen filter in more than two decades.

Bemotrizinol’s approval expands the U.S. list of allowed sunscreen ingredients to 17, and it is expected to be used in products possibly before the end of summer.

The move comes with the first U.S. product launch featuring BEMT, Parsol Shield from DSM Nutritional Products, which will have an 18-month exclusivity period before others can use the ingredient.

The approval reflects changes in U.S. regulation that permit consideration of non-animal, laboratory evidence under a new law, broadening the set of permissible ingredients.

The approval process followed years of effort, with the initial filing in 2005 and prior FDA proposals in 2025, amid criticisms from groups like the Environmental Working Group about slow progress.

Bemotrizinol had long been used in Europe, Australia, and Asia, and had been investigated after DSM applied for its use in concentrations up to 6%.

BEMT stands out for providing stronger UVA protection and broader spectrum coverage, and it is more stable under sun exposure than many existing filters.

In the U.S., most chemical UV filters require combinations to achieve broad-spectrum protection; BEMT could offer robust single-filter coverage, potentially changing formulation practices.

Experts believe BEMT addresses consumer concerns about efficacy and feel, potentially encouraging higher daily sunscreen use.

Bemotrizinol could influence consumer choices, product formulations, and regulatory discussions surrounding sunscreen safety and efficacy.

Safety and efficacy testing for BEMT is robust, and it is the first organic sunscreen filter to receive FDA’s GRAS status for over-the-counter use, signaling confidence in its safety profile.

Public health guidance continues to emphasize daily sunscreen use on exposed skin, with SPF 30 or higher and reapplication every two hours or after swimming/sweating.