For the second time this year, researchers at the U.S. Food and Drug Administration (FDA) have released a study of common sunscreen synthetic chemical UV filters and has established that the chemicals are absorbed into the bloodstream through the skin at concentrations far greater than the Food and Drug Administration’s safety threshold – at levels beyond what the agency considers healthy.
According to the FDA if active ingredients are found in the blood at a level of 0.5 nanograms per milliliter or higher, they should be analyzed to determine whether they increase the risk of cancer, birth defects or other adverse effects.
In its most recent study released this week, the maximum concentration of the six chemicals examined most recently by the FDA ranged from 3.3 nanograms per milliliter to 258.1, depending on the chemical and whether it was applied to the skin in the form of a lotion or spray.
Earlier this year the FDA released a study that found sunscreen chemicals could enter the body after just one day’s use and were at much higher levels than recommended. The agency analyzed four off-the-shelf sunscreen products and found that they “resulted in plasma concentrations that exceeded the threshold established by the FDA for potentially waiving some nonclinical toxicology studies for sunscreens.”
Previous studies have indicated a possible association between some of the chemicals and health risks such as endocrine disruption and reproductive harm, but no comprehensive safety data are available.
The FDA study which was published in January in the Journal of the American Medical Association, examined avobenzone, oxybenzone, octocrylene, homosalate, octisalate and octinoxate—six of the most commonly used synthetic UV filters/active ingredients in sunscreen.
A proposed FDA rule which was expected to be finalized last November, would have required the industry to complete additional testing of up to a dozen chemicals to make sure sunscreens using them are safe.
But the rule reportedly got sidetracked when the coronavirus (COVID-19) pandemic struck. Oddly, the CARES Act, which dealt primarily with an economic response to the pandemic, made changes to how over-the-counter products like sunscreen are regulated. For now, at least, the status quo prevails. The Cares Act overhauled how over-the-counter drugs, including sunscreens, are regulated, and it retained the 1999 sunscreen rule, which says the active ingredients currently on the market are safe and effective.
The FDA says it is not recommending that consumers spending time in the sun avoid using sunscreen. Using a mineral-based sunscreen instead of a chemical-based product, the agency says. Its now-abandoned sunscreen rule recognized the minerals zinc oxide and titanium oxide as safe and effective.