For the first time in more than 25 years, the U.S. Food and Drug Administration (FDA) has approved a new sunscreen ingredient: bemotrizinol, also known as BEMT. It has been widely used in Europe and many countries around the world, including Israel, since 1999. The ingredient protects against both UVA and UVB radiation, is minimally absorbed into the skin and is approved for use in adults and children from six months of age at concentrations of up to 6%.
U.S. Health Secretary Robert F. Kennedy Jr. said that “bemotrizinol has been used safely in Europe for decades, and FDA’s action will increase competition and consumer confidence in sunscreen products.” The approval aligns with the Trump administration’s Make America Healthy Again (MAHA) initiative, under which the FDA has pledged to advance innovation in sunscreen products and improve regulatory processes that have lagged behind other countries.
The reason for the approval is a well-known limitation in U.S.-made sunscreens. Chemical UV filters work by absorbing into the skin and triggering a reaction that converts ultraviolet radiation into heat. However, the chemical ingredients currently used in the US mainly protect against UVB rays, which cause visible sunburn, but are less effective against UVA rays, which penetrate deeper into the skin and are a major cause of skin cancer, premature aging and immune system damage.
In contrast, mineral sunscreens, which contain ingredients such as zinc oxide, sit on the surface of the skin and physically reflect sunlight. Because they are not absorbed into the skin, they tend to cause minimal irritation or toxicity. A study by the Environmental Working Group found that U.S. sunscreen products provide on average only 24% of the UVA protection implied by their SPF rating.
Bemotrizinol bridges this gap. It protects against both types of radiation and is photostable, meaning it does not break down under sunlight, unlike avobenzone, currently the only widely used U.S. chemical ingredient that provides significant UVA protection. “unlike the older non-mineral filters, it can be combined with zinc oxide to provide strong broad spectrum protection with less white cast,” said Alexa Friedman, senior scientist at the EWG. Out of 550 sunscreen products recommended in the EWG 2026 report, 497 are primarily mineral-based.
Bemotrizinol was approved in Europe in 1999 and first submitted for FDA approval in 2005, but it was delayed for decades due to the agency’s heavy bureaucracy regarding over-the-counter drug ingredients. It became the first ingredient to go through an accelerated approval pathway authorized by Congress in 2020.
“This is exactly the kind of progress we can achieve when we modernize our processes and apply sound science to regulatory decisions,” said Dr. Mike Davis, acting director of the FDA’s drug evaluation center.
Some of the delay also stemmed from safety concerns about existing ingredients. In 2019, FDA scientists found that six of the most common chemical sunscreen ingredients could enter the bloodstream at potentially unsafe levels after just one day of use. Two of them, homosalate and oxybenzone, remained in the bloodstream above safety thresholds for more than two weeks after use stopped. None of these ingredients has been formally re-evaluated since and the FDA has not yet issued updated regulations.
“For decades, Americans have used outdated sunscreen tech while the rest of the world moved forward. The approval of bemotrizinol will help change that,” said David Andrews, chief scientist at the EWG.
What happens next?
Bemotrizinol will initially be sold in the U.S. by Dutch manufacturer DSM Nutritional Products under the brand name Parsol Shield, launching later this year. After an 18-month exclusivity period, other manufacturers will be able to incorporate it into their products.
Sunscreen manufacturers welcomed the decision but called on the FDA to continue advancing. ““While we commend FDA for this progress, continued efforts are needed to establish a more efficient and modern approach for approving additional sunscreen active ingredients,” said a spokesperson for the Personal Care Products Council.
Sunscreen application
Applying sunscreen is one of the most important and proven steps in preventing skin cancer.
Broader reform proposals for sunscreen regulation, submitted in 2019 and published in 2021, including clearer labeling requirements for active ingredients and SPF levels, have still not been finalized.
While the U.S. approval is major news domestically, Israeli consumers are already familiar with the ingredient, even if they are not aware of it. In Israel, as in Europe, some sunscreen products are classified as cosmetics rather than drugs, unlike in the U.S. where the FDA regulates them as drugs. As a result, European and Asian products containing bemotrizinol, often sold under the brand name Tinosorb S, have been available in Israel for years. Anyone buying sunscreen in France, South Korea, Japan or Israel has likely already been using the ingredient without knowing it. To check whether a product contains it, look for “Bemotrizinol” or “Tinosorb S” in the ingredients list.