FDA says sunscreen concerns remain unaddressed, renews call for safety data

WASHINGTON – The Food and Drug Administration in a proposed order is again calling on sunscreen manufacturers to address what it says are lingering safety concerns about active ingredients in their products, including oxybenzone.

The order released today says sunscreen makers have failed to answer the FDA’s 2019 call to conduct studies on the health effects of sunscreens, including the extent chemicals in the products can enter the bloodstream. In fact, the FDA says two new studies on the absorption of sunscreen chemicals reinforce the need for the data the agency has sought for more than two years.

“Sunscreen chemicals like oxybenzone pose significant health concerns, but the sunscreen industry continues to bury its head in the sand,” said Scott Faber, EWG’s senior vice president for government affairs. “We’re grateful the FDA continues to demand basic data on the health effects of these chemicals.”

In 2019, the FDA concluded that 12 active ingredients commonly found in sunscreens, including oxybenzone, need additional safety data. The other ingredients are cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone and avobenzone.

Those ingredients are used in about 60 percent of the sunscreens assessed in EWG’s Guide to Sunscreens.

Oxybenzone is found in about 20 percent of the products assessed by EWG. The substance is absorbed through the skin in large amounts and may be a potential endocrine disruptor. In the past year, new studies have also raised new concerns about the possible endocrine-disrupting effects of homosalate and avobenzone.

Oxybenzone, octinoxate, octisalate, octocrylene, homosalate and avobenzone are all absorbed into the body after one use, according to studies published by the FDA. The same research also found that they could be detected on the skin and in the blood weeks after they were last used.

“Sunscreen sales have increased dramatically, so sunscreen companies can certainly afford to conduct the studies needed to ensure their customers are safe,” Faber said.


The Environmental Working Group is a nonprofit, non-partisan organization that empowers people to live healthier lives in a healthier environment. Through research, advocacy and unique education tools, EWG drives consumer choice and civic action. Visit www.ewg.org for more information.

Want to take EWG’s sunscreen tips wherever you go?
Areas of Focus
Disqus Comments

Related News

Continue Reading