FDA Approves Bemotrizinol: First New Sunscreen in 20 Years

The Food and Drug Administration expanded its list of allowed sunscreen ingredients on Tuesday to include the chemical compound bemotrizinol. This marks the first time in more than 20 years the FDA has permitted a new compound onto its sunscreen ingredient list. The approval comes after years of advocacy by dermatologists and health organizations pushing for better sun protection options.

Bemotrizinol, also known as BEMT, has long been popular in Europe, Australia, and some Asian countries. Experts hail the ingredient as a safer and more effective option than many chemical filters currently available in the United States. The change has been eagerly anticipated for years, with dermatologists aware of its ability to provide superior protection against harmful ultraviolet rays.

“This is a meaningful advancement for sunscreen innovation in the US,” Dr. Jessica Weiser, a dermatologist and founder of Weiser Skin MD, told The Post. “Bemotrizinol has been widely used in Europe for years, and dermatologists have long been aware of its ability to provide broad-spectrum protection against both UVA and UVB rays.”

US Health and Human Services Secretary Robert F. Kennedy announced that the ingredient has been used safely in Europe for decades. The FDA’s action will increase competition and consumer confidence in sunscreen products, he noted in a statement. The approval represents a significant shift in how American consumers can protect themselves from sun damage.

Understanding UV Protection and Current Limitations

Bemotrizinol functions as a UV light filter, blocking harmful ultraviolet rays from the sun. To be most effective, these filters need to be broad-spectrum, meaning they block both UVA and UVB rays. UVA rays cause aging and wrinkles, while UVB rays cause sunburn, according to the American Academy of Dermatology. Both contribute to skin cancer, according to the Skin Cancer Foundation.

UV filters come in two formats: mineral or chemical. Mineral sunscreens contain zinc oxide or titanium dioxide and block both UVA and UVB rays, but often leave a white cast on the skin. Currently, the chemical filters available in the United States protect against either UVA or UVB. None are broad-spectrum on their own, and products often contain a mix to block both types of rays.

Chemical sunscreens also break down in the sun and need regular reapplication. 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 rays, which drive premature aging, suppress the immune system, and are the primary contributor to skin cancer.

Why Bemotrizinol Stands Out

Bemotrizinol is broad-spectrum and far more stable, so it doesn’t break down in the sun. It also has low levels of absorption into the body, according to the FDA. There has been concern that other sunscreens may seep into the bloodstream, though it remains unclear whether this is harmful. The newest ingredient will be included in the GRASE category because absorption into the skin is low.

The oil-soluble chemical offers protection against both UVB and UVA rays. While UVA rays penetrate deep into skin, causing premature aging and the development of skin cancers, UVB rays directly damage cellular DNA, which can create mutations that lead to basal cell carcinoma, squamous cell carcinoma, and melanoma. Skin cancer is one of the most common cancers in the US, with more than 5 million people diagnosed every year.

Peer-reviewed research by the Environmental Working Group has found US sunscreens deliver on average just 24% of the UVA protection implied by their sun protection factor, or SPF, labels. Bemotrizinol changes this equation significantly.

Enhanced Protection and Safety Profile

Alexa Friedman, a senior scientist at EWG, explained that bemotrizinol 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. The ingredient 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.

“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 in a statement.

The FDA previously designated zinc oxide and titanium dioxide as the only two active ingredients that are Generally Recognized As Safe and Effective, or GRASE. Other common chemical filters, like oxybenzone, remain under safety review as their long-term safety and potential toxicity is unclear. Bemotrizinol now joins this exclusive approved list.

Industry and Consumer Impact

The Environmental Working Group, an activist organization that advocates for stricter sunscreen regulations, praised the FDA’s move. The group said that bemotrizinol offers better protection against UVA in particular. David Andrews, the organization’s chief science officer, called it a great day for American consumers and everyone who has fought to improve sunscreen options.

“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.

Of the 550 sunscreen products recommended by EWG in their recent 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. Newer products on the market have overcome the white cast concern that plagued earlier formulations.

Looking Ahead

The popular ingredient often used in Korean skin products is a skin-protecting chemical that dermatologists praise as great for skin. Sunscreens with bemotrizinol are expected to become available to American consumers soon, according to the ingredient manufacturer DSM-Firmenich. Having another FDA-recognized sunscreen filter available expands options and supports the development of more elegant, effective formulations that can encourage daily sunscreen use.

The approval represents a meaningful step forward in sunscreen innovation and consumer protection. With broader spectrum coverage, greater photostability, and lower skin absorption, bemotrizinol offers American consumers access to sun protection technology that has been available in other parts of the world for years. This advancement may encourage more consistent sunscreen use and better long-term skin health outcomes for millions of Americans.