For the first time in twenty years, the FDA has just added a new ingredient to its list of active ingredients authorized in over-the-counter (OTC) sun protection products. THE bémotrizinol (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 active ingredient added to the US over-the-counter sunscreen product monograph since the late 1990s.
The final decision comes seven months after the FDA published a first draft order on December 11, 2025.
“This is precisely the type of progress we can make by modernizing our procedures and applying rigorous science to our regulatory decisions,” underlines the Dr. Mike Davis, Acting Director of the FDA’s Center for Drug Evaluation and Research (CDER). “The FDA is committed to ensuring American consumers have access to the most effective and safe treatments, especially when it comes to over-the-counter products like sunscreen.”
Broad spectrum UV filter
Bemotrizinol is a broad-spectrum UV filter that protects against ultraviolet A and B rays. Tests have demonstrated its low skin absorption.
According to dsm-firmenich, which manufactures and markets bemotrizinol under the PARSOL Shield brand, clinical studies “conducted with nearly 500 participants representative of the diversity of the American population demonstrated exceptional UV effectiveness, excellent tolerance and an excellent safety profile” for this UV filter.
“The FDA’s approval of PARSOL Shield represents a major breakthrough for sun protection in the United States. It builds on years of scientific leadership and regulatory excellence, while helping to fill a persistent innovation gap in the market. After more than twenty years, this new active ingredient finally delivers what our customers have been waiting for. It enables sunscreen manufacturers to develop next-generation, globally deployable solutions that improve the consumer experience,” comments Parand Salmassinia, president of the Beauty & Care division of dsm-firmenich.
Already approved in many parts of the world, bemotrizinol offers sunscreen formulators in the United States new opportunities to create lightweight sunscreens with strong photostability.
The Personal Care Products Council (PCPC)the trade organization representing the beauty and personal care industry in the United States, has welcomed the FDA’s addition of bemotrizinol (BEMT) to its list of “generally recognized as safe and effective” (GRASE) UV filters.
“BEMT is a broad-spectrum, photostable UV filter that provides effective protection against harmful UV rays and has been used safely around the world for years. Expanding access to innovative sunscreen ingredients is a crucial step to modernizing the U.S. sunscreen market, providing more consumer choice and preventing skin cancer,” it says.
For its part, theEnvironmental Working Groupan association campaigning for stricter regulation of sun protection products, welcomes the FDA’s decision, emphasizing that bemotrizinol offers better protection against UVA.
“This is a great day for American consumers and all those who have fought for more sun protection options and close the UVA protection gap in the United States,” said David Andrews, scientific director of the organization, in a press release.
