FDA Proposes Major Updates for OTC Sunscreen

Prompted by the latest scientific data, the U.S. Food and Drug Administration (FDA) has proposed a new rule that would update regulations on most over-the-counter sunscreen products sold in America.

Announced February 21, 2019, the proposal addresses sun protection factor (SPF) levels, types of products, labeling requirements, and the safety of active ingredients.

The FDA’s commissioner, Scott Gottlieb, MD, recognized that the effort is a long time in coming, saying that some requirements for sunscreen products haven’t been updated in decades.

“Since the first evaluation of these products, we know much more about the effects of the sun and about sunscreen’s absorption through the skin,” Dr. Gottlieb said in a statement. “The proposal we’ve put forward would improve quality, safety, and efficacy of the sunscreens Americans use every day.”

Which Sunscreen Ingredients Are Being Reviewed for Their Safety?

Of the 16 sunscreen ingredients currently available for use, just two — zinc oxide and titanium dioxide — have been identified as “generally recognized as safe and effective” or GRASE.

Two other ingredients (PABA, or para-aminobenzoic acid, and trolamine salicylate), however, are not considered safe or effective under the proposed new FDA rule.

“PABA has been shown to absorb UV light, but there are some early data that suggest that it may not be blocking the cellular damage induced by ultraviolet light,” says Erum Ilyas, MD, a dermatologist in King of Prussia, Pennsylvania, and a member of the Society for Pediatric Dermatology. “It has also been implicated in cases of contact dermatitis,” which is a common type of eczema marked by inflammation of the skin.

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Dr. Ilyas adds that trolamine may be able to combine with nitrites to potentially contribute to cancer development, and both chemicals may be endocrine disrupters.

As far as the remaining 12 sunblock chemicals are concerned, the FDA notes that more data is needed to determine their safety and effectiveness. These ingredients are cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, and avobenzone.

“The announcement is not saying that these ingredients are completely unsafe, just that there is insufficient evidence to make a conclusion,” says Seemal Desai, MD, a dermatologist in Plano, Texas, and a board of directors member with the American Academy of Dermatology.

Because the research is uncertain, Michele S. Green, MD, a dermatologist with Lenox Hill Hospital in New York City, stresses that she won’t be advising her patients to throw away their current sunblock. “The takeaway is that there are more unknowns than knowns in this FDA statement,” says Dr. Green. “If you want to be conservatively cautious, just look for a sunscreen that has zinc oxide or titanium oxide in it.”

Currently, people living in Canada, Australia, Japan, and countries in Europe have access to different sunscreens from people in the United States, and these products may do a better job at preventing skin cancer, according to a report in Bloomberg Business. Some dermatologists see this move by the FDA as a step toward having access to more and better sunblocks.

“We want to make sure that Americans can get new and advanced UV filtering ingredients, many of which are available in other countries but can’t be used here because they haven’t been through the FDA process,” says Dr. Desai.

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How the Proposal’s SPF Clause May Offer You More Protection From the Sun

Not protecting yourself from the sun’s UV rays is a major risk factor for skin cancer. The American Academy of Dermatology Association (AADA) advises a comprehensive sun protection plan that includes seeking shade; wearing protective clothing, including a lightweight long-sleeved shirt, pants, a wide-brimmed hat and sunglasses; and generously applying a water-resistant, broad-spectrum sunscreen to exposed skin. Broad-spectrum means the block protects from both UVA (long-wave) and UVB (short-wave) rays.

The AADA also suggests using products with an SPF of 30 or higher. The new FDA proposal recommends raising the maximum SPF value on sunscreen labels from SPF 50+ to SPF 60+.

“I tell my patients the higher the SPF, the better,” says Desai. “Research says that an SPF 30 blocks about 98-plus percent of rays, so anything higher will only get an incremental increase. I still think, even though you might be blocking just 1 percent more rays with a higher SPF, if that 1 percent offers you more protection, why not do it?”

Which Sunscreen Products Would Be Affected by the Rule?

The new proposal identifies types of sun protection products that are considered generally safe and effective, such as sprays, oils, lotions, creams, gels, butters, pastes, ointments, and sticks.

The FDA is still looking to evaluate products with sun protection ingredients, including wipes, towelettes, body washes, and shampoos. The proposal also advises that sunscreen-and-insect-repellent combinations should not be considered safe and effective.

Another recommendation is to improve labeling by providing actual information on active ingredients and a user alert regarding skin cancer and skin aging information for sunscreens that have not been shown to help prevent skin cancer. Labels should also indicate SPF, broad-spectrum, and water resistance.

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Why the Proposed Rule Has Been a Long Time Coming

In 2014, the Sunscreen Innovation Act was established to speed the process for the review of safety and effectiveness of nonprescription sunscreen active ingredients. But change has taken some time.

“When the FDA announced that it was going to change and regulate more of the safety of nonprescription sunscreens and their active ingredients, it was a big shocker,” says Green. “And then nothing happened. This proposed regulation has been coming for years.”

Yet still, the final verdict is not due until November of 2019. Right now, the FDA is in the review process and accepting comments on the proposed regulation.

“So for users, there is no cause for alarm and no need to panic,” says Desai. “If you got a questions, get an expert opinion from a board-certified dermatologist, especially if you have changing skin lesions, concerning moles, new growths, sunburns, and questions about sunscreen.”

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