The FDA is Tightening Restrictions on This Dermatologist-Favorite Skincare Product

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The FDA is Tightening Restrictions on This Dermatologist-Favorite Skincare Product featured image
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There’s been a lot of talk about the negative effects of sunscreen on the coral reef in Hawaii and Key West, FL lately, however, a new announcement from the Food and Drug Administration is now highlighting the potential risk of sunscreen on humans. According to Reuters, the FDA is proposing new regulations on over-the-counter sunscreens in order to ensure the safety of the products sold.

The proposal, which was announced on Thursday, discusses the safety of popular sunscreen ingredients, their dosage forms, sun protection factor (SPF) and broad-spectrum requirements, CNN reports. Of the 16 currently marketed active ingredients used in sunscreen, only two ingredients—zinc oxide and titanium dioxide—are currently recognized as safe chemicals in sunscreen. Twelve of these ingredients do not have the data necessary to prove their safety and two of those 16 ingredients, trolamine salicylate and PABA, have just been declared unsafe by the FDA and will be banned from non-prescription sunscreen products. These findings have prompted the FDA’s new proposal to necessitate additional testing on those 12 active ingredients before allowing them to be sold on store shelves.

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“Since the initial evaluation of these products, we know much more about the effects of the sun and about sunscreen’s absorption through the skin,” FDA Commissioner Dr. Scott Gottlieb said in a statement. Since sunscreen is absorbed into the body at a much higher rate than we previously thought, it’s vital to ensure the ingredients in each product aren’t harmful.

According to Brookline, MA dermatologist Papri Sarkar, MD, banning ingredients PABA and trolamine salicylate is a good move by the FDA. “[PABA] has been a troublesome ingredient for many, many years,” says Dr. Sarkar. “It causes irritant and allergic reactions in tons of people.”

Additionally, the new regulations would also raise the maximum proposed SPF value on sunscreen labels from SPF 50+ to SPF 60+. While there are sunscreens on the market that boast an SPF 100, Scott Faber, the senior vice president for government affairs at Environmental Working Group, says these products have “bamboozled” consumers into believing they’re getting extra protection from the sun when they’re not, NY Post reports.

Dr. Sarkar agrees with raising the SPF maximum, saying that “numerous studies have shown that when patients apply sunscreen on their own they apply anywhere from 25 to 50 percent of the sunscreen they’re supposed to. So instead of getting an SPF 30 when they apply something labeled SPF 30, they’re really getting at max a SPF 15. Getting to a SPF 60 means more people will hopefully get to an SPF 30.”

Once approved, these new regulations might trigger a huge revamp of the sunscreen market, with companies quickly reformulating their products to avoid ingredients that the FDA finds questionable and possibly even pulling popular sunscreens from store shelves if they don’t meet the new requirements.

Ultimately, the proposed regulation should not deter anyone from continuing to use SPF. After all, sunscreen is vital for preventing skin cancer (and premature wrinkles!), so it should still be a fundamental part of all skincare routines.

We’ve reached out to a dermatologist for comment and will update this post once we hear back.

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