FDA approves first new sunscreen ingredient in more than 20 years

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The Food and Drug Administration (FDA) on Tuesday added bemotrizinol to the list of permitted sunscreen active ingredients, the first such addition since the late 1990s.

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

Health and Human Services Secretary Robert F. Kennedy Jr. said in the release that his agency is “advancing innovation” in the sunscreen market with the move.

“Bemotrizinol has been used safely in Europe for decades, and FDA’s action will increase competition and consumer confidence in sunscreen products,” Kennedy added.

The addition of bemotrizinol is in line with a September report from the Trump administration’s Make America Health Again Commission, which included Kennedy, Agriculture Secretary Brooke Rollins, Education Secretary Linda McMahon and other administration officials.

The 20-page report called on the FDA to “promote innovation in the sunscreen market, and improve regulatory processes for over-the-counter sunscreen, which has fallen behind other countries.”

DSM Nutritional Products, part of Dutch multinational corporation DSM, submitted a request for the FDA to add bemotrizinol, at concentrations up to 6 percent, to the over-the-counter sunscreen monograph last year.

The FDA proposed the addition in December, writing in an order that studies submitted by DSM sufficiently show that repeat exposure to bemotrizinol “did not cause irritation or elicit a sensitization, photo-allergenic, or phototoxicity response.”

The agency will finalize the order on Wednesday. The final order states that “there is adequate evidence from two independent human clinical efficacy studies” to support the efficacy of bemotrizinol as an active sunscreen ingredient.

Dr. Mike Davis, the acting director of the FDA Center for Drug Evaluation and Research, said in the release that the agency is “committed to ensuring the American consumer has access to the most effective and safe therapies, including over-the-counter products like sunscreens.”

DSM will exclusively sell bemotrizinol, under the brand name Parsol Shield, in the U.S. for 18 months from when the order goes into effect on Aug. 9. After that period ends, other manufacturers will be able to market it.

The FDA recommends that you should apply sunscreen 15 minutes before exposure and cover your entire face and body — except for the eyes and mouth. You should reapply at least every two hours, and more often if you’re swimming or sweating, according to the FDA.

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Brooke Rollins

Linda McMahon

Robert F. Kennedy Jr.

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