By Vincent Gallon
After two decades of regulatory gridlock, the US will finally have access to a sunscreen that is already widely used in Europe and Asia. On Tuesday, the US Food and Drug Administration (FDA) added bemotrizinol to its list of permitted active ingredients in sunscreen products, finally opening up the US market for a new generation of sunscreens.
For the first time in twenty years, the FDA has just added a new ingredient to its list of permitted active ingredients in over-the-counter (OTC) sunscreen products. Bemotrizinol (or BEMT) can now be used to formulate sunscreens sold in the United States.
Also known as PARSOL Shield [1], bemotrizinol is a chemical UV filter widely used in sunscreens in Asia and Europe. This is the first asset added to the US over-the-counter solar product monograph since the late 1990s.
The final decision comes seven months after the FDA published a first draft of the order on December 11, 2025.
“This is precisely the kind of progress we can make by modernizing our procedures and applying rigorous science to our regulatory decisions,” says Dr. Mike Davis, Acting Director of the Centre for Drug Evaluation and Research (CDER). of the FDA. “The FDA is committed to ensuring that American consumers have access to the most effective and safest treatments, especially when it comes to over-the-counter products like sunscreen.”
