The FDA approved the first new sunscreen ingredient in nearly 20 years

Too greasy. Too ghostly. Too chalky. Too thick. American sunscreens are often the subject of ridicule for their unpleasant look or feel. That’s in part why only 13 percent of American adults apply sunscreen every day—despite its importance for protecting skin from both cancer and aging. But a shift in the sunscreen market is finally here.

Today, the U.S. Food and Drug Administration approved bemotrizinol (BEMT) for use in sunscreens—the first new ingredient to make the list in almost 20 years. Manufacturers are expected to incorporate BEMT to their product lines, possibly before the end of summer.

A staple in European and Asian sunscreens for more than two decades, BEMT offers several benefits over the older ingredients, technically known as filters. It protects against a broader range of ultraviolet radiation, lasts longer on the skin, irritates less, and, crucial for many users, has a more pleasing feel.

“It’s quite overdo to come to the U.S. market, because it has important advantages over our current sunscreens,” says Kathleen Suozzi, a dermatologic surgeon at the Yale School of Medicine.

The new filter offers broad-spectrum protection

The sun emits two types of harmful ultraviolet radiation: short-wavelength ultraviolet B (UVB) that causes sunburns and some skin cancers, and longer-wavelength ultraviolet A (UVA)—the vast majority of exposure—that penetrates deeper and causes wrinkles, age spots, and cancer.

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Some sunscreens protect against one, but the most effective cover both. Bemotrizinol offers this broad-spectrum protection—and filters an even longer range of radiation than most current ingredients, says Saranya Wyles, a dermatology researcher at the Mayo Clinic, whose laboratory does work for a sunscreen manufacturer.

Sunscreens come in two categories: chemical and physical. BEMT is a chemical sunscreen, like avobenzone and oxybenzone, which works by converting the sun’s radiation into heat that quickly dissipates. Physical, or mineral, sunscreens, including zinc oxide and titanium dioxide, instead reflect UV rays off the skin. Both types effectively prevent the radiation from penetrating the skin’s surface.

Some consumers worry that chemical sunscreens can be absorbed into the body, especially after a study in 2020 found certain ingredients appeared in the bloodstream in higher amounts than the FDA recommends.

But there’s no evidence even the increased blood levels make those ingredients dangerous, Suozzi says. “People have been slathering sunscreens on their body for decades, and we don't see an increased signal of anything concerning. The fact that it's absorbed is probably not clinically relevant at all.”

Still, BEMT is absorbed in lower amounts than older filters. “It has a larger molecular structure and a higher molecular weight. That allows it to sit on top of the skin and have lower dermal penetration,” Suozzi says. Other properties enable it to last longer because it breaks down more slowly when exposed to sunlight.

New FDA regulations may bring even more sunscreens to market

BEMT’s approval was a longtime coming. Many countries regulate sunscreens as cosmetics, but the U.S. considers them an over-the-counter drug, requiring more extensive testing. This has led to Europe allowing some 30 ingredients in its sunscreens, while the U.S. approved just over a dozen, the last in 1999.

Laboratory and human studies must show that sunscreen ingredients are generally recognized as safe and effective, or GRASE, which requires animal studies. But a new law passed last fall enabled other types of laboratory evidence. The act also instructed the agency to review sunscreens considered safe and effective elsewhere, such as BEMT.

Preliminary guidance offered by the FDA six months ago found that BEMT met its safety thresholds at concentrations up to six percent. With the agency’s formal sign-off, that amount of the filter has now landed on its list of allowable sunscreen ingredients.

Many applaud the new review process and the impending authorization of BEMT. “For too long, American families have had to rely on outdated ingredients while likely safer, more effective options were available overseas,” Melanie Benesh, an executive at the nonprofit Environmental Working Group said in a statement. In 2021, the organization’s test of 51 U.S. sunscreens found many provide only half the protective prowess as stated on their label’s sun protection factor (SPF) rating.

Even on cloudy days, people still need sunscreen

Dermatologists hope the new options encourage more people to regularly protect themselves from the sun’s rays. Daily sunscreen use slashes cases of the deadly skin cancer melanoma in half and reduces localized squamous cell carcinoma by 40 percent, according to a study that tested 1,600 people for four years and followed them for more than a decade after.

The American Academy of Dermatology (AAD) recommends that everyone use sunscreen daily on all body parts not covered by clothing. (Even people with darker skin or who never burn still require the UVA protection.) This includes overcast days, because up to 80 percent of harmful UV rays penetrate through clouds, and also when people are driving. “You're still getting UVA through the window tint,” Wyles says.

The AAD calls for using a shot-glass amount of a broad-spectrum product with a SPF of 30 or higher. Half-a-teaspoon worth—the size of a classic board game die—should go on the face, ears, and neck.

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To remain effective, sunscreen must be reapplied every two hours—more often when swimming or sweating—or, if people spend most of the day in an office, whenever they head outside. “I tell people to keep sunscreen in the car or their purse to remind you to apply again,” Wyles says. Those who remain inside at the height of the day still need coverage during early morning or late afternoon outings.

Sleep, exercise, stress reduction, and a healthy diet are all crucial to maintaining healthy skin function and appearance throughout a person’s life, Wyles says. “But the number one skin longevity product is sunscreen.”