On June 9, 2026, the U.S. Food and Drug Administration (FDA) announced the addition of bemotrizinol to its list of permitted sunscreen active ingredients. This marks the first new ingredient added to the over-the-counter sunscreen monograph since the 1990s.
Bemotrizinol has been used as a sunscreen ingredient in Europe and many other regions around the world for years. The proposal for FDA approval was submitted by dsm-firmenich, under the tradename PARSOL Shield.
“This is exactly the kind of progress we can achieve when we modernize our processes and apply sound science to regulatory decisions,” said Mike Davis, MD, PhD, acting director of the FDA Center for Drug Evaluation and Research. “The FDA is committed to ensuring the American consumer has access to the most effective and safe therapies, including over-the-counter products like sunscreens.”
According to the organization’s press release, bemotrizinol provides protection against ultraviolet A and B rays and has low levels of absorption through the skin into the body. The ingredient is considered generally recognized as safe and effective (GRASE) for use in sunscreens by adults and children six months of age or over.
“The FDA’s rigorous standards ensure consumers can be confident in the sunscreens and other nonprescription drugs they use,” said Karen Murry, MD, director of the Office of Nonprescription Drugs. “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.”
Bemotrizinol is the first new active ingredient to be added to an over-the-counter monograph under the new process established by the CARES Act.
