FDA approves first new sunscreen ingredient in 20 years

American sunscreen makers can now use a new active ingredient that regulators approved for the first time in two decades, a move that could soon give consumers products with broader UVA protection and more elegant formulas on store shelves. The Food and Drug Administration finalized approval of bemotrizinol, also known as bis-ethylhexyloxyphenol methoxyphenyl triazine, on June 9, 2026, and said manufacturers may begin including it in sunscreens on Aug. 9, 2026.

The agency said bemotrizinol protects against both ultraviolet A and ultraviolet B rays, is absorbed only at low levels through the skin, and is generally recognized as safe and effective for adults and children 6 months of age and older. The final order allows concentrations of up to 6 percent, opening the door for reformulated products that the industry says could feel sheerer and lighter while covering a broader range of UV exposure.

The decision also lays bare how slowly U.S. sunscreen regulation has moved compared with other markets. The ingredient has been used for years in Europe, Asia and many countries around the world, while the American Academy of Dermatology Association said Europe approved it in 2000. The association called the FDA action an important public health step that could expand access to safe and effective sunscreens and help prevent skin cancer, the most common cancer in the United States. It also noted that the United States still trails many other countries in approved sunscreen ingredients, with nearly twice as many available elsewhere.

The approval came after DSM Nutritional Products LLC filed an over-the-counter monograph order request on Sept. 23, 2024, seeking use of bemotrizinol at up to 6 percent. FDA issued a proposed order on Dec. 11, 2025, the public comment period closed Jan. 26, 2026, and the agency said the final action followed seven months later. It was the first new active ingredient added to the OTC sunscreen monograph since the late 1990s and the first added through the streamlined administrative order process created by the CARES Act.

The move fits a broader push inside the U.S. Department of Health and Human Services to modernize sunscreen regulation. FDA said the approval aligns with the Make America Healthy Again Strategy Report’s priority to improve oversight of over-the-counter sunscreens, while HHS Secretary Robert F. Kennedy Jr. said the change should increase competition and consumer confidence. KFF Health News reported that officials, environmental health advocates and skin care industry groups had hoped the approval would help restore Americans’ wavering faith in sunscreen, a market where global rivals have long offered more advanced filters.