The active ingredients of commonly used sunscreens end up in the bloodstream at much higher levels than guidelines from US health regulators and warrant further safety studies, according to a small study conducted by US Food and Drug Administration (FDA) researchers and published on Monday.
Over-the-counter (OTC) products originally marketed to prevent sunburn with little regulation are widely used to block radiation from the sun that can cause skin cancer, the most common malignancy in the US.
The study of 23 volunteers tested four sunscreens, including sprays, lotion and cream, applied to 75 percent of the body four times a day over four days, with blood tests to determine the maximum levels of certain chemicals absorbed into the bloodstream conducted over seven days.
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The study found maximum plasma levels of the chemicals it tested for — avobenzone, oxybenzone, octocrylene and, in one sunscreen, ecamsule — to be well above the level of 0.5 nanograms per milliliter (ng/ml) at which FDA guidelines call for further safety testing.
The maximum concentration of avobenzone was found to be 4ng/ml and 3.4ng/ml for two other sprays, 4.3ng/ml for a lotion and 1.8ng/ml for the cream.
The researchers did not name the products used in the study.
The effects of plasma concentrations exceeding the FDA’s limit are not known and need to be further studied, the research team wrote in the JAMA: Journal of the American Medical Association.
The results in no way suggest that people should stop using sunscreen to protect against the sun’s harmful ultraviolet rays, researchers said.
“The demonstration of systemic absorption well above the FDA guideline does not mean these ingredients are unsafe,” Robert Califf and Kanade Shinkai said in an editorial that accompanied the study in JAMA.
“The study findings raise many important questions about sunscreen and the process by which the sunscreen industry, clinicians, specialty organizations and regulatory agencies evaluate the benefits and risks of this topical OTC medication,” they added.
David Andrews, a senior scientist at the nonprofit health and environmental advocacy group Environmental Working Group, called for thorough testing of sunscreen ingredients.
“Now the FDA is proposing that these common ingredients must undergo additional testing,” Andrews said.
However, the Personal Care Products Council trade association said that the study had limitations and expressed concern that it might confuse consumers.
Sunscreens in the study were used at “twice the amount that would be applied in what the scientific community considers real-world conditions,” council head scientist Alexandra Kowcz said.
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