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As of the publish date, we have 17 approved UV filters in the U.S., the last of which was approved 25 years ago. However, companies only utilize a few of those 17—the rest are either too difficult to formulate or may cause side effects. On the flip side, there are over 30 filters actively approved and used in Europe, Korea, and Australia, nearly all of which, according to board-certified dermatologist Jessie Cheung, MD, are longer lasting than their U.S. counterparts, and come with better broad-spectrum coverage and less potential for allergies and irritation. How exactly did this happen?
According to double board-certified dermatologist Karan Lal, MD, it’s largely the result of how governments classify and regulate sunscreen.
In the United States, sunscreens are deemed over-the-counter drugs and are thus limited to the FDA’s rules, regulations, and rigorous testing and approval processes. As Kelly Dobos, cosmetic chemist and professor of cosmetic science at the University of Cincinnati, explains, sunscreens in the U.S. must meet the stringent criteria of being efficacious and safe enough for consumers to use without the guidance of a physician and a prescription. As a result, the data needed to apply for new sun filter approval is extensive, costly, and time-consuming.
Even if all the necessary paperwork and requirements are met, the FDA still needs to be consulted and give final approval. At least eight new sunscreen filters have been filed and awaiting FDA approval since 2002.
“The FDA moves extremely slowly to approve new over-the-counter drugs,” explains board-certified dermatologist and founder of REMEDY, Muneeb Shah, MD. “There have been several proposals that never went into effect, and no sense of urgency by the FDA to update the list.”
Then, there’s the whirlpool of misinformation surrounding sunscreen safety, which cosmetic chemist Joyce de Lemos, co-founder of Dieux Skin, says has made the American public’s perception of newer sunscreen filters difficult to predict.
It’s no wonder companies are hesitant to invest in launching new sun filters in the U.S.—an investment that hasn’t proven successful since the 1990s.
Meanwhile, in Europe, Asia, and other areas of the world, sunscreens are classified as cosmetics, like moisturizers or lipstick, and don’t need to adhere to the stringent regulations of over-the-counter drugs, making it far easier to gain approval. This means non-U.S. beauty brands can access more and better UV filters than their U.S. counterparts.
However, experts aren’t necessarily pushing the FDA to change the classification of sunscreen. “I support the classification of sunscreens as over-the-counter drugs because it ensures the products are legitimate,” Dobos explains. “They are held to higher standards for manufacturing, safety, and efficacy. But that doesn’t take away from the fact that there are drawbacks to this approach.”