The U.S. Food and Drug Administration is requesting additional information on the safety of sunscreen ingredients — including the oxybenzone used in 70% of sunscreens available in the USA.

The FDA recently issued a proposed rule to update regulatory requirements for most sunscreen products in the United States, where sunscreens are regulated as drugs.

According to the agency:

“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. As noted in the proposed rule, FDA expects that sunscreen active ingredients that are absorbed into the bloodstream at a level of 0.5 ng/mL (nanograms per milliliter) or higher, or that have potential safety concerns, would generally need to undergo further testing to help determine if they increase the risk for cancer, birth defects, or other adverse effects. All of the active ingredients in the study noted above were absorbed in levels substantially higher than the 0.5 ng/mL threshold value cited in the proposed rule. However, without further testing, FDA does not know what levels of absorption can be considered safe.”

According to Stream2Sea Founder Autumn Blum:

“More than 95% of Americans have oxybenzone in their bloodstream — but melanoma rates in the U.S. have more than doubled in the past 30 years,” she notes. “Clearly we need to rethink sunscreens.”

An award-winning cosmetic chemist and avid diver, Blum was on a liveaboard diving trip in Palau — one of the most pristine coral reefs in the world — and noticed something:

“People would slather themselves with sunscreen, jump overboard, then climb back aboard, wash off with soap and shampoo that went straight into the water, and slather on more sunscreen.”

Blum came home inspired to formulate products that didn’t harm the ecosystems she loves and created Stream2Sea, the only line of sunscreens and personal care products to be third-party tested for aquatic and marine safety.

Oxybenzone — used in approximately 70% of the sunscreens sold in the U.S. — kills coral larva at concentrations as low as 62 parts per billion, or about one drop in six Olympic-sized swimming pools.

Only two ingredients — including the titanium dioxide in Stream2Sea — of the 18 ingredients currently allowed in U.S. sunscreens are still officially known to be “Generally Recognized As Safe and Effective” (GRASE). Two ingredients are definitely not GRASE and manufacturers have been asked to provide additional information to re-evaluate the safety of the other 12.

The FDA also has asked that manufacturers of sunscreens rated higher than SPF 15 match the SPF value for UVA rays to meet the current rating for UVB light.

Blum said:

“UVB rays are what cause most sunburns, but UVA rays are 30 to 50 percent more prevalent, consistent all day long, and move through clouds, glass and the outer layer of skin – and are strongly implicated in aging.”

Ingredients in chemical sunscreens absorb only a small part of the UVB spectrum, so manufacturers typically use multiple chemicals to meet FDA standards. Mineral sunscreens, on the other hand, sit on the skin and reflect the sun’s rays.

According to Blum:

“There are two key advantages here,” she said. “The first, of course, is full-spectrum coverage. But because the chemical sunscreens are absorbed into the skin where they absorb sunlight, they’re creating a cascade of free radicals that are likely to be involved in the increase of cancer rates.”

Stream2Sea
Stream2Sea

And then you have the body’s reaction to the chemicals themselves. At least nine of the sunscreen ingredients being reviewed are known endocrine disruptors that produce adverse developmental, reproductive, neurological, and immune effects in both humans and wildlife. Scientists are documenting a wide variety of impacts in humans, from infertility in men to endometriosis among women, and even an increased risk for potentially lethal birth defects. The increased use of chemical sunscreens may even help explain why unexplained infertility has become so prevalent.

And speaking of fertility, pregnant women are the most vulnerable population. It easily penetrates human skin and enters the blood stream where even unborn children are exposed to it. It has been linked to a potentially fatal birth defect among women who use it in their first trimester. Over-exposing children to sunscreen that contains multiple endocrine disrupters can cause long-term problems in reproductive and developmental health. Sunscreens are readily absorbed into their skin, and the more often it is applied, the greater the exposure.

While Blum started Stream2Sea specifically to protect coral reefs, the issue expands far beyond her initial focus. Ongoing research shows that oxybenzone reacts with chlorine in swimming pools to create even more toxic agents, and it is not removed from most wastewater treatment plants.

“That means that someone in Minnesota who spends their afternoon in a pool will likely excrete oxybenzone in their urine that washes down the Mississippi River, potentially impacting the drinking water sources of hundreds of communities along the way — and then moving through the Gulf of Mexico and ending up in the coral reefs off the Florida Keys.”

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