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FDA Study Finds Sunscreen Ingredients Absorbed Into Bloodstream, Further Testing Needed

The study found that six active sunscreen ingredients are absorbed into the bloodstream after just one use.

A new study funded by the U.S. Food and Drug Administration shows that six active ingredients common in chemical sunscreens are absorbed into the bloodstream after just one use, and that concentrations of each ingredient found in plasma continued to increase with continued daily use over time.

The study, Effect of Sunscreen Application on Plasma Concentration of Sunscreen Active Ingredients, was published Tuesday in the Journal of the American Medical Association. The clinical trial, a follow-up to a prior study published in May, involved a larger number of people, more ingredients and more sunscreen formats, including lotions, aerosol and non-aerosol sprays and pump sprays.

The results of the study confirmed the FDA’s 2019 findings that avobenzone, oxybenzone and octocrylene are all absorbed into the bloodstream and will require further safety testing before being considered GRASE — generally recognized as safe and effective. While confirming the last study’s result, this new study added three more to the list of sunscreen ingredients that concentrate in the bloodstream at levels that require them to undergo further testing. These ingredients are homosalate, octisalate, and octinoxate.

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While acknowledging that these ingredients will need to undergo further testing before being officially recognized as safe, the FDA has stressed that the study results should not deter consumers from applying sunscreen, as sunscreens “can prevent skin cancer and protect the skin from sunburn and other UV damage, when used with other sun protective measures.”

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In another statement that is sure to confuse consumers, the FDA study states that “sunscreens can be used in substantial amounts over the course of a lifetime in primary sunscreen drug products and in sunscreen drug-cosmetic combination products.”

The FDA last year issued a proposed rule that would update regulatory requirements for sunscreens in the U.S. and since then, the beauty industry has been waiting to see if ingredients such as avobenzone and oxybenzone, known to make for more cosmetically elegant formulations than titanium and zinc-oxide based products, will be declared safe.

Hawaii has already banned oxybenzone and octinoxate, said to be potentially harmful to aquatic life.

Meanwhile, consumers have added sunscreen actives to the growing list of ingredients they are concerned with. While the FDA has not done studies on the following, it did acknowledge “questions about the potential for oxybenzone and homosalate to affect endocrine activity,” and that “multiple active ingredients lack nonclinical safety assessment data, including systemic carcinogenicity, developmental, and reproductive studies to determine the clinical significance of systemic exposure of sunscreen active ingredients.”

Beauty industry lobbying groups have responded in divergent ways.

The Personal Care Products Council and Consumer Healthcare Products Association registered the study as good news, pointing to the fact that the active ingredients have not been deemed unsafe — yet.

“There were no serious drug-related adverse events reported in the trial, consistent with the excellent safety record associated with sunscreen active ingredients over decades of real-world use,” the statement read. “We will continue to work cooperatively with FDA to determine what additional studies are needed to ensure the ongoing safety of sunscreen active ingredients in the marketplace.

While no serious adverse effects were noted during the latest study, 14 of the 48 participants developed rashes after applying sunscreen up to four times a day over the course of 21 days.

Meanwhile, the Environmental Working Group suggested consumers avoid ingredients found in chemical sunscreens.

“Until such evidence is made available, consumers should opt for SPF products that use the mineral active ingredients, zinc oxide and titanium dioxide, which the agency has proposed to classify as safe,” said Nneka Leiba, vice president of EWG’s healthy living science program.

Since Hawaii issued its reef-safe laws in 2018, mineral formulations have been on the rise. Neutrogena has come out with new Zinc-based formulas, and Supergoop reformulated many of its popular sku’s without octinoxate.