FDA clears UV filter long used in Europe and Asia, first new one in 20 years

For the first time in 20 years, the US Food and Drug Administration approved a new sunscreen ingredient — bemotrizinol or BEMT — to its list of permitted active ingredients in over-the-counter (OTC) sunscreens. The compound can now be used in sunscreens marketed in the United States.

Also known as PARSOL Shield [1], bemotrizinol is a chemical UV filter that has been used widely in sunscreens in Asia and Europe for decades. Bemotrizinol is the first new active ingredient added to the OTC sunscreen monograph since the late 1990s.

FDA finalized this action within seven months of issuing the proposed order on December 11, 2025.

“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.”

Broad-spectrum UV filter

Bemotrizinol is broad-spectrum UV filter, which provides protection against both ultraviolet A and B rays and tests have shown that it has low levels of absorption through the skin into the body.

According to dsm-firmenich, which manufactures and markets bemotrizinol under the brand PARSOL Shield, clinical studies “involving nearly 500 participants representing the diversity of the U.S. population, demonstrate exceptional UV efficacy, excellent tolerability, and an excellent safety profile” for the UV filter.

“The FDA approval of PARSOL Shield represents an important step forward for sun protection in the United States. It builds on years of scientific leadership and regulatory excellence, while helping address a longstanding innovation gap in the market. After more than two decades, this new active ingredient delivers what our customers have been waiting for. It gives suncare manufacturers the flexibility to develop next-generation, globally scalable solutions that enhance the consumer experience,” commented Parand Salmassinia, Beauty & Care President at dsm-firmenich.

Already approved across multiple regions around the world, bemotrizinol provides formulators of sun care products in the United States with new opportunities to create lightweight sunscreen textures with strong photostability.

The Personal Care Products Council (PCPC), the trade organization representing the beauty and personal care industry in the U.S. has applauded the FDA addition of bemotrizinol (BEMT) to its list of UV filters ‘generally recognized as safe and effective’ (GRASE).

“BEMT is a photostable, broad-spectrum UV filter that provides strong protection against harmful UV rays and has been safely used globally for years. Expanding access to innovative sunscreen ingredients is a critical step toward modernizing the U.S. sunscreen landscape, increasing consumer choice, and providing tools to support skin cancer prevention,” they added.

The Environmental Working Group, an activist group that advocates for stricter sunscreen regulations, praised the FDA’s move and said that bemotrizinol offers better protection against UVA in particular.

“This is a great day for American consumers and everyone who has fought to improve sunscreen options and close the UVA protection gap in U.S. sunscreens,” David Andrews, the organization’s chief science officer, said in a statement.