As part of its efforts to advance sunscreen innovation, the U.S. Food and Drug Administration (FDA) has added bemotrizinol to the list of permitted sunscreen active ingredients. The first new active ingredient added to the over-the-counter (OTC) sunscreen arsenal since the late 1990s, bemotrizinol has been marketed as a sunscreen ingredient and used safely in Europe and many countries around the world for years.
Under FDA rules, all sunscreens must protect against UVB rays, which cause most sunburn, as well as UVA rays, which contribute to skin cancer risk and premature skin aging.
Currently available chemical-blocking ingredients only protect against one or the other, with sunscreen manufacturers mixing the chemicals to achieve “broad spectrum protection.” While mineral-based ingredients like zinc oxide block both UVA and UVB rays, they can leave a chalky white residue that some consumers find off-putting.
Bemotrizinol protects against both UVA and UVB rays, has low levels of absorption through the skin into the body, and is generally recognized as safe and effective (GRASE) for use in sunscreens by adults and children 6 months of age and older.
The first new active ingredient added to an OTC monograph under the streamlined process established by the CARES Act, bemotrizinol was approved less than seven months after the FDA issued the proposed order on December 12, 2025. The public was given a year to submit comments, which the agency reviewed before issuing the final order.
“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, MD, PhD, 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.”
The addition of bemotrizinol to the list of approved ingredients is expected to increase competition and consumer confidence in sunscreen products. The ingredient protects against both UVA and UVB rays without leaving the white streaks often associated with mineral-based sunscreens, causes little irritation, and demonstrates minimal absorption into the body. CBS News chief medical correspondent Jon LaPook, MD, added that because bemotrizinol is more photostable than many currently available sunscreen ingredients, its protection may last longer.
Initially, bemotrizinol will be sold in the U.S. by the Dutch manufacturer DSM Nutritional Products under the brand name Parsol Shield. After an 18-month exclusivity period, the ingredient will be available for use by other manufacturers.
“For decades, Americans have used outdated sunscreen technology while the rest of the world moved forward,” said David Andrews, PhD, chief science officer of the Environmental Working Group, which has long advocated for updated sunscreen standards and access to new ingredients. “The approval of bemotrizinol will help change that.”
