Recently, the U.S. Food and Drug Administration (FDA) issued a proposed rule to update regulatory requirements for most sunscreen products in the United States, where sunscreens are regulated as drugs. This action was aimed at bringing over-the-counter (OTC) sunscreens up to date with the latest scientific standards. As part of this rule, the FDA is asking industry and other interested parties for additional safety data on 12 active sunscreen ingredients currently available in marketed products. A key data gap for each of these 12 active sunscreen ingredients is understanding whether, and to what extent, the ingredient is absorbed into the body after topical application.
Theresa Michele, MD, director of the Division of Nonprescription Drug Products in the FDA Center for Drug Evaluation and Research, said the new rules include:
Active ingredient safety. "First, we propose that of the 16 currently marketed active ingredients, two -- zinc oxide and titanium dioxide -- are great for use in sunscreens," she says. Two other ingredients, PABA and trolamine salicylate, are not considered safe, she said. These two ingredients are not currently on the U.S. market.
"There are 12 ingredients for which we propose there are insufficient data [to make a positive generally recognized as safe and effective (GRASE) determination]." According to the FDA, 12 sunscreen ingredients lack enough data to support whether they are GRASE. They are cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, and avobenzone.
Among the concerns are that oxybenzone ''is absorbed through the skin to a greater extent than previously understood," the rule says. There are questions about is potential to be an endocrine disrupter, a chemical that can cause cancer, birth defects, and other developmental disorders. Nearly all of the 12 have limited or no data about their absorption, the FDA says.
A new report in the Journal of the American Medical Association has given us some food for thought: There’s a chance that sunscreen could potentially be dangerous. Here’s how: Sunscreen ingredients can travel through the skin and build up in the bloodstream, the new report suggests. This finding has raised concerns about how sunscreen might affect reproductive and developmental health and whether it can cause cancer, according to an editorial accompanying the new report.
For the new study, scientists from the U.S. Food and Drug Administration (FDA) studied the effects of sunscreen on 24 healthy people. They tested four different sunscreens—two sprays, one lotion, and one cream—each applied four times a day, to 75% of the body surface, for four days. Blood samples were then taken from the participants to determine how much of four specific sunscreen ingredients—avobenzone, oxybenzone, ecamsule, and octocrylene—ended up in their bloodstreams. And it turns out, it was a significant amount.
The Hawaii State Legislature has passed a bill that would prohibit the sale of non-prescription sunscreens containing oxybenzone and other chemicals that may be damaging to coral reefs (e.g. octyl methoxycinnamate), effective January 1, 2021.
Key West has also banned the sale of sunscreens that contain the ingredients oxybenzone (and octinoxate). Starting in 2021, no stores in Key West can carry sunscreens that contain the reef-damaging chemicals.
The U.S. Virgin Islands became the first American jurisdiction to ban sunscreens containing oxybenzone and octinoxate effective Dec. 31, to help restore its coral reefs and marine ecosystems. This legislation, which bans importing sunscreens with the ingredients beginning Dec. 31, bans the sale or distribution of these sunscreens after March 30, 2020, and prohibits transporting them into or possessing them after Jan. 1, 2021. First-time violators can be fined $1,000, the same fine enacted previously by the Pacific island nation of Palau which adopted a similar bill.
The Caribbean island of Bonaire unanimously voted to ban the sale of reef-killing sunscreens in its stores by 2021. Scientists studying the effects of oxybenzone and octinoxate on reefs have conducted research in the Caribbean and said “about 90 percent of the reefs in the Caribbean have disappeared since 1980.”
While it’s not technically banned here, popular vacation spots in Mexico are some of the most likely places for Americans to be asked not to use their harsh sunscreen. Popular cenote swimming holes in the Riviera Maya that are home to copious animal life typically ask that visitors only use natural sunscreens. Ecotourism preserves and natural water parks like Xel Ha, Xcaret Park, Garrafon Natural Reef Park, and similar spots in Cozumel and Playa del Carmen are also asking visitors to use only natural sunscreens.
Once you’re there, resorts and shops can (and will) charge a pretty penny for natural sunscreens. Stock up before you go to avoid the price gouge, and order online to ensure you get the best price. Avoid all aerosol sunscreens, and check the ingredients list yourself to make sure oxybenzone and octinoxate aren’t listed; not all sunscreens marketed as “natural” are actually reef safe. Truly reef safe sunscreens containing non-nano zinc oxide and non-nano titanium dioxide protect against the sun and do not harm coral.