FDA approves new sunscreen ingredient used for years in Europe and Asia

By Sandee LaMotte, CNN

(CNN) — For the first time in 20 years, the US Food and Drug Administration approved a new sunscreen ingredient — bemotrizinol, or BEMT — that experts say is a safer option than many chemical ingredients currently in use in the United States.

“Bemotrizinol has been used safely in Europe for decades, and FDA’s action will increase competition and consumer confidence in sunscreen products,” US Health and Human Services Secretary Robert F. Kennedy said in a statement announcing the change.

Adding BEMT is welcome news to many because there are few choices on US store shelves that are both safe and effective, according to an annual report by the Environmental Working Group, or EWG, a nonprofit health and environmental advocacy organization.

Sunscreens on US store shelves today excel at blocking the radiation that causes visible sunburns, called ultraviolet B rays. However, critics say they routinely fail to shield against deep-penetrating ultraviolet A, or UVA rays, which drive premature aging, suppress the immune system and are the primary contributor to skin cancer, according to the American Cancer Society.

Peer-reviewed research by EWG has found US sunscreens deliver on average just 24% of the UVA protection implied by their sun protection factor, or SPF, labels.

However, BEMT is a chemical filter that provides adequate UVA protection, is not easily absorbed into the skin, and has the most robust safety data on any UV filter to date, said Alexa Friedman, a senior scientist at EWG.

“Bemotrizinol changes the calculus of sun care. It is highly photostable — meaning it won’t break down when hot summer sun hits your skin — unlike avobenzone, currently the only non-mineral filter in the U.S. that provides meaningful UVA coverage,” she said in a statement.

“Better yet, unlike the older non-mineral filters, it can be combined with zinc oxide to provide strong broad spectrum protection with less white cast,” Friedman said.

A new, safer chemical sunscreen

Of the 550 sunscreen products recommended by EWG in their 2026 report, 497 are predominantly made from minerals that sit on the skin and physically deflect and block the sun’s rays. Because mineral-based sunscreens are not absorbed into the dermis, they cause little skin irritation or toxicity. In the past, products were known for the “white cast” they left on the skin, but newer products on the market have overcome that concern.

Chemical sunscreens, however, are designed to soak into the skin and work by creating a chemical reaction that absorbs ultraviolet radiation as energy, dispersing it as heat. A dozen types of chemicals were used for decades in sunscreens without concern. Then, in 2019, FDA scientists found six of the most commonly used ingredients could enter the human bloodstream at unsafe levels after only one day of use.

Those chemicals remained in the blood days after application stopped. In fact, two of the ingredients — homosalate and oxybenzone — stayed in the bloodstream above safety thresholds for more than two weeks.

All of the chemicals are part of a dozen the FDA wants manufacturers to research before they can be considered GRASE or “generally regarded as safe and effective.” To date, those studies have not been announced, nor has the FDA passed any updated regulations on those chemicals, experts say.

That’s a key reason the approval of a new, safer chemical ingredient for sunscreens is such good news, said David Andrews, EWG’s chief science officer.

“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,” Andrews said in a statement.

“For decades, Americans have used outdated sunscreen tech while the rest of the world moved forward. The approval of bemotrizinol will help change that,” Andrews added. “This is a win that has been a long time coming.”

More to be done

The Personal Care Products Council, which represents sunscreen manufacturers, applauded the FDA’s action as “a significant advancement for the personal care products industry and consumers,” but called on the FDA to do more.

“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 PCPC spokesperson Tesia Williams in an email.

Recommended changes to how the FDA regulates sunscreens were first proposed in 2019 and announced in 2021. Recommendations included requiring sunscreen manufacturers to clearly label their products with active ingredients on the front, as well as clearer formats for SPF, broad-spectrum and water-resistant statements. To date, those proposals remain in limbo.

The FDA’s action on bemotrizinol aligns with the Make America Healthy Again (MAHA) Strategy Report priority, the administration stated. “FDA will promote innovation in the sunscreen market, and improve regulatory processes for over-the-counter sunscreen, which has fallen behind other countries.”

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