WASHINGTON, D.C. — The Food and Drug Administration approved the sunscreen ingredient bemotrizinol on June 9, adding it to its list of ingredients generally recognized as safe and effective. The FDA considered bemotrizinol for approval over a period of nearly two decades.

Bemotrizinol has been used in sunscreens in Europe, Australia, and Asia for years prior to U.S. approval. "Bemotrizinol has been used safely in Europe for decades," said Health and Human Services Secretary Robert F. Kennedy Jr. in an announcement about the approval. "FDA's action will increase competition and consumer confidence in sunscreen products." In 2024, Kennedy pledged to oppose what he described as the FDA's "war on public health" and "aggressive suppression" of sunshine. The Environmental Working Group and skin care industry groups advocated for the approval. Sunscreen products containing bemotrizinol are expected to become available in the U.S. by the end of the year.

The FDA approval includes bemotrizinol on the same list as zinc oxide and titanium dioxide. DSM-Firmenich, a manufacturer of sunscreen chemicals, submitted the application for its approval. "People will talk more positively about sunscreens," said Carl D'Ruiz, a senior manager at DSM-Firmenich. Bemotrizinol allows for sunscreen formulations that are lighter and less opaque on the skin compared to many existing American options.

"It has strong safety data," said Alexa Friedman, an environmental epidemiologist at the Environmental Working Group. "The documents submitted to the FDA to achieve generally recognized as safe and effective include tests of irritation, sensitization to allergies, two-year animal studies for carcinogenicity, and reproductive health." Friedman also noted that the European Union had concluded homosalate was not safe at concentrations previously used. "The European Union had recently concluded that homosalate was not safe at concentrations that they were using and recommended a very low percentage, which was effectively a ban," said Friedman. "The U.K. also issued a safety evaluation."

Approximately one in five people in the U.S. will develop skin cancer by age 70. Skin cancer is the most common cancer in the U.S. About 3.3 million people in the U.S. are diagnosed annually with basal and squamous cell carcinomas. "One in five Americans will be diagnosed with melanoma," said Dr. Lauren Taglia, a dermatologist at Northwestern Medicine. "It is reported that 23 Americans die a day from the disease." "Bemotrizinol is also referred to as Tinosorb S and PARSOL Shield," said Taglia. "Multiple names exist for the same ingredient, but it is broad spectrum, meaning it covers the UVA and UVB wavelengths of light." "Mineral sunscreens are preferred, especially in patients with more sensitive skin or in children, but they tend to leave a white cast on the skin," said Taglia. "Chemical sunscreens are more easily rubbed into the skin, so patients tend to like that formulation better than mineral sunscreens." "We want to meet patients and consumers where they are," said Taglia. "Making it easier for people to apply a product gives them reassurance that it is regarded by the FDA as safe and effective."

"It is a good UVA block," said Mark Mitchnick, a pediatrician who invented transparent zinc oxide. "It gives us good flexibility. In my mind, it allows you to make really good products without using avobenzone, which I think has a lot of baggage." Mitchnick expects companies to release hybrid sunscreen products combining bemotrizinol and zinc oxide later this year. Avobenzone decreases in effectiveness when exposed to light and has been associated with allergic reactions. Hawaii banned the sale of octinoxate due to concerns it harms marine life. "Properly formulated sunscreens do an excellent job blocking solar UV, which we know is responsible for skin cancers and aging," said J. Frank Nash, a senior director and research fellow at Procter & Gamble.

"People are not shunning sunscreen because they have stopped believing ultraviolet radiation is dangerous," said Joseph Mizikovsky, a director of the Australian Sunscreen Council. "They are shunning it because they have lost trust in what is in the bottle." Mizikovsky added that the FDA should act faster to ban filters that lack safety data. "My view is the FDA should move faster to ban filters that are missing safety data," said Mizikovsky. "The public should focus on physical protection, including shade, clothing, hats, and sunglasses, with sunscreen as the last layer, not the first." Australia experienced a recall of sunscreen products containing bemotrizinol due to claims of ineffectiveness.