What’s the Sunscreen Situation?

Given recent news reports, you may be wondering if sunscreens are safe for you and your family, as well as the planet. Elizabeth Buzney, MD, an expert and member of our Photobiology Committee, helps sort it all out.

By Lorraine Glennon

The first question that sprang to mind for many people after the February 2019 announcement that the U.S. Food and Drug Administration (FDA) will be issuing new regulations governing the sale and use of sunscreens was, “Sunscreen is a drug?” Cosmetics and supplements such as vitamins and herbal remedies are not analyzed by the FDA for safety and effectiveness, so it may be a surprise to learn that the agency has classified sunscreens as over-the-counter medications since 1978 and regulates them as such.

Yet according to former FDA director Scott Gottlieb, whose statement emphasized that broad-spectrum sunscreens with a sun protection factor (SPF) of 15 or higher are critical to preventing skin cancer and protecting the skin from sun damage, “some of the essential requirements for these preventive tools haven’t been updated in decades.” Hence the agency’s decision to reevaluate several of sunscreens’ key ingredients and ensure that they are GRASE — an acronym for “generally recognized as safe and effective.”

At the time of the announcement, the agency said that, based on available data, only two of the 16 active ingredients currently found in commercial sunscreens — zinc oxide and titanium dioxide — achieve the GRASE designation. Two non-GRASE ingredients — PABA and trolamine salicylate — are no longer permitted in over-the-counter medicines, including sunscreens. As for the remaining 12 ingredients, the agency announced that it is asking for new data to ensure they meet GRASE guidelines. It’s important to know that the FDA has not deemed these ingredients unsafe, only that their credentials are out of date.

This process should be good news, at least in theory, says Elizabeth Buzney, MD, associate vice chair of clinical affairs for the Department of Dermatology at Brigham and Women’s Hospital and assistant professor of dermatology at Harvard Medical School. Yet she notes that this new push on the part of the FDA seems to have overlooked a major premise of the Sunscreen Innovation Act of 2014, which (as the bill’s name implies) was to facilitate the introduction of new GRASE ingredients for sunscreens, including many found in popular European formulas that have never been approved for use in this country.

“The focus in the February proposal seems to have shifted from new ingredient applications, which so many people [including The Skin Cancer Foundation] have been advocating for, toward just looking at the ingredients we already have,” says Dr. Buzney, who adds that this analysis is strictly her own reading of the FDA’s announcement and that its ramifications are far from clear at this early stage. She’s got good credentials, though: Dr. Buzney is also an expert in photobiology, the interaction of ultraviolet light and skin. She serves as a volunteer member of The Skin Cancer Foundation’s Photobiology Committee.

An Ingredient in the Spotlight

Sunscreens have been shown to help prevent skin cancer, the most common cancer in the world. When headlines focus on sunscreen safety allegations, they’re not always based on strong scientific evidence. Still, consumers may worry about the products they use, or even stop using them, which could put their health at risk. In recent years controversy has swirled particularly around oxybenzone, a common ingredient in the so-called “chemical” sunscreens, as opposed to the “mineral” products based on zinc oxide and titanium dioxide. Both, however, are misleading terms, says Dr. Buzney, who points out that all sunscreen ingredients, like all molecules, are chemicals; she prefers the terms organic and inorganic, respectively, to describe each category.

Oxybenzone has been accused of being a hormone disrupter. Dr. Buzney, says, “Oxybenzone’s reputation as a hormone disrupter is mostly based on one study in which large amounts of the substance were fed to immature rats for four days and their uterine weight increased by 23 percent.” A study in JAMA Dermatology calculated it would take an average-sized woman covering 100 percent of her body every day with the recommended full amount of sunscreen about 35 years to reach that oxybenzone level, and, in fact, would take more than 275 years if using sunscreen the way most people apply it. “Unlike the rats,” she explains, “people don’t eat it, and virtually no one practices ‘perfect use,’ in which they apply — and reapply — sunscreen in the full amount and concentration recommended for optimal protection.”

She cites another study that looked at whole-body applications of sunscreens containing oxybenzone in 16 men and 17 postmenopausal women. The researchers found some statistically significant differences in three of the six hormones measured, but when the subjects continued to apply the sunscreens, the differences disappeared. The researchers concluded that the differences were related to hormone variations, not to the sunscreen use.

Controversy over Coral Reefs

Controversy about sunscreen ingredients such as oxybenzone contributing to the widespread bleaching of coral reefs is trickier, not because it has been scientifically proven or disproven but because it has taken hold in the media and the public consciousness. By far the biggest causes of reef degradation are overfishing, pollution, development and, especially, rising temperatures of ocean water due to global climate change. “There have been multiple bleaching events documented over the past 60 years, each of which coincided with a warming episode,” Dr. Buzney says. “Another thing to keep in mind is that along the Great Barrier Reef in Australia, bleaching of the coral has occurred in remote areas with infrequent human contact. So it’s a stretch to say, ‘Bleaching is directly related to sunscreen.’”

More research is needed. Still, concerns led the state legislature of Hawaii, where tons of sunscreen get washed off into its waters annually, to pass a law last year banning the sale and use of sunscreens containing oxybenzone and octinoxate (another of the 12 ingredients on which the FDA is gathering new data). Key West in Florida and the island of Palau have also implemented bans.

Dr. Buzney cites a 2018 paper by Henry W. Lim, MD, a board-certified dermatologist and chair emeritus of the dermatology department at Henry Ford Health System in Detroit, who has also been a member of the SCF’s Photobiology Committee. His study found that oxybenzone in concentrations of 33 to 50 parts per million induces coral bleaching and death in a laboratory setting — a concentration far in excess of the 0.8 to 19.2 parts per billion concentration she says is found in ocean waters surrounding the Hawaiian Islands. And the ranges around the world are similarly in the low to zero toxicity levels for coral reef bleaching. On the other hand, she acknowledges that there are concentrations of oxybenzone in water systems around the world, mainly because oxybenzone is not easily taken up by wastewater treatment plants. “That is problematic,” she says.

If You Are Concerned

Despite Dr. Buzney’s belief in the overall safety and efficacy of organic (or “chemical”) sunscreens after more than three decades of use in the U.S., out of an abundance of caution she advises her patients who are pregnant or breastfeeding to refrain from using these products, particularly those that contain oxybenzone. Like other substances absorbed into the skin, oxybenzone is released into the bloodstream and shows up in breast milk as well as urine — though Dr. Buzney is careful to point out that absorption does not equal toxicity.

“Simply stated, we should all be conscious of the Earth that we live on and the safety of products we use,” says Dr. Buzney. At the same time, the threat of UV-related skin cancers is so serious that no one should forgo sun protection. The science is unequivocal on that point. Is there a solution that accommodates both objectives? In terms of sunscreen, Dr. Buzney says that, for now (given that the sunscreens available in Europe contain eight ingredients not yet approved by the FDA), one choice for environmentally conscious Americans is to use the inorganic (aka “mineral”) formulations, which do not appear to have the detrimental environmental effects attributed to some ingredients: The (scant) research on this topic indicates that while uncoated zinc oxide applied directly to coral reefs in a lab setting can result in bleaching, the zinc oxide in sunscreens is coated. And titanium dioxide has no effect on reefs.

It’s also important to know that one of the reasons zinc oxide and titanium dioxide have been designated GRASE is because they’ve been shown to stay on the surface of the skin with almost no absorption into the skin, explains Dr. Buzney. “This is true whether or not the product is formulated with nanoparticles (very small particles sometimes labeled as “micronized”). The small particles help the product go on the skin without looking too white.”

The Time-Tested Alternative

While you still need to use sunscreen on any exposed skin, for those who would like to use less until we know more, there’s also the ultimate “natural,” nonchemical form of sun protection favored throughout history: covering up. “I tell my patients they can do what I do,” Dr. Buzney says. “I swim in a long-sleeved shirt, my kids swim in full-body suits, my husband swims in a long-sleeved shirt and my mother swims in a shirt and even some swim pants I bought for her.”

A bright or darkly colored, tightly woven, long-sleeved swim shirt with an ultraviolet protection factor (UPF) is cost-effective protection over the long run. And with so many children today routinely wearing such clothing, much of the fashion-related resistance to full-body beachwear may well be overcome in the future. Add a wide-brimmed hat, some 99 to 100 percent UV-blocking sunglasses and a little common sense about avoiding direct sunlight during peak hours (roughly 10 am to 4 pm), and conscientious consumers can feel confident that they’ve done a pretty thorough job of protecting themselves, their families and the planet we all inhabit together.

The Skin Cancer Foundation Is on the Case!

At the SCF, we keep up with the issues, work closely with physicians and researchers and monitor the science with the help of our Photobiology Committee. Above all, we work hard to help you protect yourself from the skin-damaging rays of the sun, which can lead to skin cancer. One out of every five Americans will develop skin cancer by the age of 70. Sunscreen is an important tool in prevention, so the last thing we want you to do is stop using it! Our best advice until the FDA has completed its research and ruling is:

Keep using the sunscreen you like. We often say the best sunscreen for you is the one you will use. Consistent protection is the key to prevention. All of the sunscreen ingredients on the market now have been in use for decades, and until we know more, the safest bet is to keep using the one you like.

If you’re concerned, try an inorganic, or “mineral” sunscreen. Look for products with zinc oxide and titanium dioxide. They’re good for sensitive skin, and micronized versions work well on darker skin tones.

Don’t forget to cover up! The Skin Cancer Foundation has always recommended clothing, hats, sunglasses and seeking shade as a first line of defense against sun damage. They’re noncontroversial, they work — and you don’t have to reapply!

Lorraine Glennon is a writer and editor based in Brooklyn, New York. She writes on health, politics, books, personal finance, art and architecture for a wide range of online and print publications.