The Food and Drug Administration announced Thursday a proposal to add another sunscreen ingredient to the U.S. approval list for manufacturers.
The FDA regulates sunscreen, but U.S. standards have not been updated since 1999. The proposal to add bemotrizinol, which is already popular in Asia and Europe, comes amid rising criticism over the lack of innovation in the U.S. sunscreen market.
Many dermatologists have been sounding the alarm over the limited options in the United States and some social media users upset about wanting more variety have fueled an anti-sunscreen movement.
The agency said in a statement that the active ingredient, bemotrizinol, is “generally recognized as safe and effective for use by adults and children 6 months of age and older, expanding consumer choice.”
Henry W. Lim, senior vice president of academic affairs and former chair of dermatology at Henry Ford Health and spokesman for the American Academy of Dermatology, said this is a good move because it’s one of the most well-studied, broad spectrum UV filters.
“So far it has been very difficult to get any new filter approved in the U.S., and so this one is a breakthrough,” Lim said.
The proposed ingredient is a chemical sunscreen, which forms a thin protective film to absorb UV radiation, as opposed to mineral sunscreens such as zinc oxide, which physically block UV rays from reaching the skin.
Lim also said that the ingredient is photostable so it does not easily break down in sunlight, and its large molecular size limits skin penetration, which is a concern with some older chemical filters.
If approved, the FDA would place bemotrizinol in the same regulatory status as zinc oxide and titanium dioxide, the two mineral filters recognized as safe and effective.
Michael Girardi is a professor of dermatology at the Yale School of Medicine and said one of the reasons for lag in approvals can be attributed to concerns of some studies that showed sunscreen ingredients were being absorbed into the bloodstream at higher levels than were previously known.
“That really made the FDA pump the brakes on new applications at that point, largely because of significant safety concerns,” Girardi said.
Skin cancer is the most common form of cancer in the U.S., according to the Centers for Disease Control and Prevention, and more than 8,000 people die annually of it.
Dermatologists recommend daily use of broad-spectrum SPF 30 or higher. Mineral sunscreens with zinc oxide or titanium dioxide are also considered safe.
Along with wearing protective clothing, regular sunscreen use has been shown to reduce the risk of skin cancer. In the Nambour Skin Cancer Prevention Trial, a randomized controlled study in Australia that followed more than 1,600 people for about 10 years, participants who used sunscreen daily developed fewer melanomas compared with those who applied it only occasionally.
Another prospective cohort study of more than 143,000 Norwegian women found that using sunscreen with an SPF of 15 or higher was associated with a 33 percent lower melanoma risk compared with using lower-SPF products.
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