FDA Announces Long-Awaited Changes to Sunscreen Regulations

Of 16 common active ingredients, only two are declared safe and effective.
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FDA announces changes to sunscreen regulations

FDA announced earlier this month a change to over-the-counter sunscreen regulations. The proposal addresses the safety of certain active ingredients, declaring only two of 16 that are currently used – zinc oxide and titanium oxide – as safe and effective.

The rule deems two other ingredients – PABA, or para-aminobenzoic acid, and trolamine salicylate – not safe or effective. Some research suggests that PABA may not effectively block the cellular damage caused by UV light. Trolamine, meanwhile, may contribute to cancer development. Both chemicals may also be endocrine disruptors. Neither of these ingredients is used in American sunscreen brands at this time.

The rule stipulates that more research is needed to ascertain the safety and effectiveness of the remaining 12 ingredients. Some, however, have been linked to health problems, such as oxybenzone, which may contribute to increased risk of endometriosis in women and disrupted sperm production in men. 

“We expect many companies to quickly reformulate to avoid those ingredients that the FDA considers unsafe or for which there is not enough data to prove safety,” says Scott Faber, the senior VP for government affairs at the Environmental Working Group, which applauded the announcement.

Sunscreens with these 12 ingredients will nevertheless remain on the U.S. market for the time being, so consider referring to our expert-approved natural sunscreen list for the best and safest options.

The FDA's new regulations also address SPF levels, which will now be capped at 60+. In addition, the new rule will require active ingredients to be listed on the front of sunscreen bottles, and all sunscreens above SPF 15 will have to contain broad-spectrum protection.

For FDA commissioner Scott Gottlieb, these changes have been a long time coming.

“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,” Gottlieb says in a statement. “The proposal we’ve put forward would improve quality, safety, and efficacy of the sunscreens Americans use every day.”

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