FDA Approves Bemotrizinol for Sunscreen

The U.S. Food and Drug Administration added bemotrizinol to the list of permitted sunscreen active ingredients, marking a significant milestone in the agency’s efforts to advance sunscreen innovation.

Bemotrizinol, also known as BEMT, is the first new active ingredient added to the over-the-counter (OTC) sunscreen monograph since the late 1990s.

FDA finalized this action within seven months of issuing the proposed order, as seen here. The new ingredient has been marketed as a sunscreen ingredient in Europe and many countries around the world for years.

“This is exactly the kind of progress we can achieve when we modernize our processes and apply sound science to regulatory decisions,” said Mike Davis, M.D., Ph.D., Acting Director of the FDA Center for Drug Evaluation and Research (CDER). “The FDA is committed to ensuring the American consumer has access to the most effective and safe therapies, including over-the-counter products like sunscreens.”

FDA Background

Bemotrizinol provides protection against both ultraviolet A and B rays and has low levels of absorption through the skin into the body. The FDA considers bemotrizinol to be generally recognized as safe and effective (GRASE) for use in sunscreens by adults and children 6 months of age and older, said FDA.

DSM Nutritional Products LLC submitted an OTC monograph order request to add bemotrizinol, at concentrations up to 6 percent, as a new active ingredient in the OTC monograph for sunscreens. The FDA reviewed the request and proposed to amend the OTC monograph to add bemotrizinol as a sunscreen active ingredient.

“The FDA’s move to expand sunscreen options is a pivotal step for photoprotection and skin cancer prevention in the US,” noted Carl D’Ruiz of DSM-Firmenich on LinkedIn.

The agency issued a proposed order on December 12, 2025, to this effect, and the public could submit comments from December 12, 2025 – January 26, 2026. The agency reviewed public comments on the proposed order and is now issuing the final order.

In February 2026, DSM’s Parsol Shield (bemotrizinol) was approved for use in Canada, as reported in Happi.

Check out Happi’s coverage of DSM’s suncare ingredients here and here.