FDA Approves New Sunscreen Ingredient Bemotrizinol

The U.S. Food and Drug Administration (FDA) has approved bemotrizinol, a new ingredient for over-the-counter sunscreens, marking the first addition to the list of permitted active ingredients in more than two decades.

According to multiple reports, bemotrizinol is considered Generally Recognized As Safe and Effective (GRASE) by the FDA. The approval allows up to 6% concentration of the ingredient in sunscreen products for adults and children aged 6 months and older. Health and Human Services Secretary Robert F. Kennedy Jr. praised the decision, stating that "bemotrizinol has been used safely in Europe for decades, and FDA's action will increase competition and consumer confidence in sunscreen products."

Experts highlight that bemotrizinol offers broad-spectrum protection against both UVA and UVB rays. Dr. Amank Jambhekar, a melanoma surgical oncologist told HuffPost, that the ingredient is photostable, meaning it doesn’t break down easily in sunlight. As it’s oil-soluble, it dissolves in oil rather than water, making it easy to spread across the skin. It also has low skin absorption and is suitable for people with sensitive skin.

Currently available chemical-blocking ingredients only protect against one or the other. Companies generally mix the chemicals in combination to achieve 'broad spectrum protection.' Mineral-based ingredients, including zinc oxide, block both UVA and UVB but leave a chalky white residue.

The ingredient will initially be sold as Parsol Shield, manufactured by Dutch company DSM Nutritional Products. It is expected to launch later in 2026 according to the Associated Press (AP). The ingredient will be available for use by other manufacturers after an 18-month exclusivity period.

The FDA noted that bemotrizinol is "generally recognized" as safe and effective for adults and children aged six months and older. Commissioner Marty Makary commented in a statement that the agency has historically moved too slowly, leaving Americans with fewer options than consumers abroad. He emphasized the need to modernize regulations to ensure timely access to the best over-the-counter products available.

Karen Murry, MD, acting director of the Office of Nonprescription Drugs in Maryland, commented that bemotrizinol would be a welcome addition to the current array of effective sunscreen active ingredients already available to American consumers. The FDA continues to regulate sunscreen products to ensure they meet safety and effectiveness standards while encouraging public use of numerous protective measures.