FDA鈥檚 Greenlight of Old Chemical Offers Chance To Restore Faith in Sunscreen
Officials, environmental health advocates, and skin care industry groups are expressing hope that the Food and Drug Administration鈥檚 approval of a sunscreen ingredient on June 9 鈥 after consideration for two decades, and global use for nearly as long 鈥 will help in sunscreen.
鈥淏emotrizinol has been used safely in Europe for decades,鈥 Health and Human Services Secretary Robert F. Kennedy Jr. about the approval. 鈥淔DA鈥檚 action will increase competition and consumer confidence in sunscreen products.鈥
Nonprofits that advocate for health, such as the Environmental Working Group, and the skin care industry alike had lobbied for approval of the ingredient, which makes sunscreens sheerer and lighter on the skin than many available American options while blocking a wider spectrum of ultraviolet rays that can cause premature aging and skin cancer.
The newly approved sunscreen filter will allow companies to reformulate sunscreens to address consumers鈥 concerns, said Carl D鈥橰uiz, a senior manager at , a Swiss maker of sunscreen chemicals that applied for the FDA approval. In addition to allowing companies to offer what the FDA calls safe and effective formulations, he said, the approval will allow sunscreens that are more like sought-after South Korean brands to be sold in the U.S. by autumn.
Confidence in U.S. sunscreen has faltered on two fronts: among those concerned about what鈥檚 in the sunscreens they use and those who believe sun exposure is healthy. But will the new ingredient win the trust of Make America Healthy Again skeptics and Gen Zers intentionally tanning? RFK Jr., strikingly bronzed, has helped stoke this confusion by pledging in 2024 to fight what he called the FDA鈥檚 鈥渨ar on public health鈥 and . Under his leadership, the FDA from a plan in March to ban people under 18 from using tanning beds.
All this matters because by age 70 in the United States. It is the in the nation, where about 3.3 million people are diagnosed each year with basal and squamous cell carcinomas.
D鈥橰uiz said he thinks bemotrizinol, also known as BEMT, will change the dynamic. 鈥淧eople will talk more positively about sunscreens,鈥 he said.
In the U.S., new sunscreen chemicals are regulated as over-the-counter drugs like aspirin or cough syrup rather than as cosmetics, as in Japan and the European Union. That means they face more elaborate testing and safety protocols, such as animal testing that runs afoul of EU laws, which is why the for bemotrizinol took nearly two decades, D鈥橰uiz said.
What鈥檚 鈥済enerally recognized as safe and effective,鈥 otherwise known as 鈥淕RASE鈥 in FDA-speak, is at the center of the American sunscreen debate. Bemotrizinol joins zinc oxide and titanium dioxide on the FDA鈥檚 .
That could help rebuild trust, said , an environmental epidemiologist at the , a nonprofit that researches the ingredients in consumer products.
鈥淚t has strong safety data,鈥 Friedman said. 鈥淭he documents submitted to the FDA to achieve 鈥榞enerally recognized as safe and effective鈥 include tests of irritation, sensitization to allergies, two-year animal studies for carcinogenicity, and reproductive health.鈥
The approval will also give consumers access to sunscreens that don鈥檛 leave as much of a white cast, she said, which makes some people hesitant to use mineral sunscreens such as zinc oxide and titanium dioxide.
Bemotrizinol鈥檚 approval won鈥檛 change the possibility of several chemicals with unclear safety profiles being added to sunscreens.
In 2019, the there was insufficient data to support a positive 鈥済enerally recognized as safe and effective鈥 determination for 12 commonly used sunscreen chemicals.
The concerns emerged after the that said some sunscreen ingredients had been found in humans鈥 bloodstreams. Though the industry has since phased out several of those chemicals lacking GRASE status, four are still widely used: avobenzone, homosalate, octisalate, and octinoxate.
鈥淭he European Union had that homosalate was not safe at concentrations that they were using and recommended a very low percentage 鈥 which was effectively a ban,鈥 Friedman said. 鈥淭he U.K. also issued a safety evaluation.鈥
Octisalate and octinoxate have been associated with disruption of the endocrine system, and octinoxate was due to concerns that it harms marine life and bleaches coral reefs.
Avobenzone breaks down when exposed to light, making it less effective, Friedman said, and has been associated with allergic reactions.
Mark Mitchnick, a pediatrician who , which is known under the brand Z-Cote, said bemotrizinol will give chemists a new tool to make sunscreens that people will want to wear.
鈥淚t鈥檚 a good UVA block,鈥 he said. 鈥淚t 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.鈥
Most of the UV rays people are exposed to are UVA rays that can penetrate the middle layer of the skin and cause up to 90% of skin aging, along with a smaller amount of UVB rays, which are . falls on the electromagnetic spectrum between X-rays and visible light.
Mitchnick said major companies have used chemical filters because they work better on a per-pound basis compared with mineral sunscreens made with zinc oxide and titanium dioxide. 鈥淭hat鈥檚 why hybrids are great 鈥 you get the best of both worlds.鈥 He said he expects companies, including , to release hybrid products containing bemotrizinol and zinc oxide later this year.
J. Frank Nash, a senior director and research fellow at Procter & Gamble, said skepticism about sunscreen is unfortunate because properly formulated sunscreens do an excellent job blocking solar UV, 鈥渨hich we know is responsible for skin cancers and aging.鈥
He worries the industry has contributed to the trust gap by , called boosters, to mineral sunscreens, to raise sun protection factor ratings, or SPF. This leads consumers to wonder what鈥檚 in the products they鈥檙e buying.
Still, in Australia, where bemotrizinol has been used in sunscreens for years, a shows that even when regulators allow lauded UV filters, bad actors can taint a whole industry.
鈥淧eople are not shunning sunscreen because they have stopped believing UV is dangerous,鈥 said Joseph Mizikovsky, a director of the . 鈥淭hey are shunning it because they have lost trust in what is in the bottle.鈥
He applauds the FDA鈥檚 transparency with American consumers about the lack of safety data for filters without GRASE status, and FDA鈥檚 insistence on mandatory microbial testing of products.
But he said the FDA could do more to rebuild trust in sunscreens.
鈥淢y view is the FDA should move faster to ban filters that are missing safety data, and the public should focus on physical protection 鈥 shade, clothing, hats, sunglasses 鈥 with sunscreen as the last layer, not the first.鈥