The FDA has added bemotrizinol to its list of permitted sunscreen active ingredients.
It is the first new active ingredient added to the over-the-counter sunscreen monograph since the late 1990s.
The ingredient protects against both UVA and UVB rays and is considered safe and effective for adults and children six months and older.
For the first time in more than 20 years, the U.S. Food and Drug Administration (FDA) has expanded the list of active ingredients that can be used in over-the-counter sunscreens.
The agency announced that it is adding bemotrizinol to the sunscreen monograph, a regulatory framework that outlines which ingredients can be used in certain nonprescription products.
The move marks a significant update for the sunscreen category, which has not seen a new active ingredient added since the late 1990s. According to the FDA, the decision reflects ongoing efforts to support innovation while maintaining the agency’s standards for safety and effectiveness.
“The FDA’s rigorous standards ensure consumers can be confident in the sunscreens and other nonprescription drugs they use,” Karen Murry, M.D., Director of the Office of Nonprescription Drugs in CDER, said in a news release. “Now, through the best available science and updated regulatory framework, we can work with companies to get innovative products to market in a more efficient manner than ever before.”
What is bemotrizinol?
Bemotrizinol is a sunscreen ingredient that has been used in Europe and other countries around the world for years. The FDA says it provides protection against both ultraviolet A (UVA) and ultraviolet B (UVB) rays. The agency also noted that the ingredient has low levels of absorption through the skin into the body.
Based on the data it reviewed, the FDA determined that bemotrizinol is generally recognized as safe and effective for use in sunscreens by adults and children who are at least six months old. The ingredient may be used in sunscreen formulations at concentrations of up to 6%.
The approval came through a process established under the CARES Act, which allows the FDA to update over-the-counter drug monographs through administrative orders. In this case, DSM Nutritional Products LLC submitted a request to add bemotrizinol to the sunscreen monograph. The FDA issued a proposed order in December 2025, reviewed public comments, and has now finalized the change.
What this means for consumers
For consumers, the biggest impact is likely to be greater choice in the sunscreen aisle over time. By adding bemotrizinol to the list of permitted active ingredients, the FDA has opened the door for manufacturers to develop and market sunscreen products that include the ingredient, provided they meet the monograph’s requirements.
The FDA says the action is intended to support innovation and increase competition in the sunscreen market. While consumers may not see new products appear immediately, the change creates a pathway for companies to bring additional sunscreen formulations to market in the future.
“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,” said David Andrews, Ph.D., chief science officer at EWG.
“For decades, Americans have used outdated sunscreen tech while the rest of the world moved forward. The approval of bemotrizinol will help change that. The FDA’s go-ahead will finally bring more effective, safer sun protection to American store shelves. This is a win that has been a long time coming."