Here's what to know—and which products may be affected.

Karen Pallarito
June 03, 2021
Advertisement

Heads up before you prep your skin for the beach this holiday weekend. An independent laboratory is calling on the US Food and Drug Administration (FDA) to issue a recall after detecting benzene, a known human carcinogen, in 78 batches of sunscreen and after-sun products.

In a "citizen petition" filed May 24, Valisure LLC said it analyzed 294 unique batches of sunscreen and after-sun products from 69 brands. (Note: a "batch" is different than a "product" as a whole—samples were taken from specific bottles of products, and contamination doesn't necessarily mean all products of the same kind contain benzene.)

FDA-Asked-to-Recall-These-Sunscreen-Brands-pexels-rfstudio-3618606
Credit: Pexels / @rethaferguson

Out of all 294 unique batches, 78 batches—or 27%—were found to contain detectable levels of benzene, with some batches containing up to three times the 2 parts per million (ppm) upper limit on benzene that the FDA allows under special circumstances, according to the lab.

Going deeper, Valisure found that 40 of those batches with detectable levels of benzene contained so much of the cancer-causing chemical that the products "should be recalled." The highest level of benzene—6.26 ppm—was detected in a batch of Neutrogena's Ultra Sheer Weightless Sunscreen Spray, SPF 100. Two different batches of the same sunscreen, each with an SPF of 70, contained 5.96 and 5.76 ppm of the chemical. Sun Bum's Cool Down Gel contained the next highest amount, at 5.33 ppm.

The full "citizen petition" posted on Valisure's website, lists all 294 product batches tested by the company—including all 78 batches that tested positive for detectable levels of benzene, and the remaining batches that had "no detectable levels of benzene."

This all sounds alarming, but before you swear off sunscreen for good (which is not a good idea!) here's what you need to know about what's going on.

What is benzene—and what makes it a human carcinogen?

Benzene is a colorless or light-yellow chemical used primarily as a solvent in the chemical and pharmaceutical industries, per the National Cancer Institute (NCI). It is also known to cause cancer in humans. Benzene exposure increases the risk of developing leukemia and other blood disorders, the NCI notes. People are primarily exposed to this chemical via cigarette smoke or by working in an industry that produces or uses benzene, it says.

The chemical is classified by the World Health Organization as a Group 1 carcinogen, indicating that there is strong evidence tying it to DNA damage and other changes that cause cancer in humans. And the FDA classifies it as a Category 1 solvent, meaning it shouldn't be used to manufacture drugs or drug products unless it's unavoidable.

What we don't know is whether benzene in sunscreens, especially in small amounts, poses the same cancer risk as other repeated and high-level benzene exposures, says Jennifer N. Choi, MD, associate professor of dermatology and chief of the division of oncodermatology at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University in Chicago. Lacking actual studies, and knowing that benzene is a carcinogen, "caution must be heeded, and benzene-containing products should be avoided for safe measure," she tells Health.

Suffice it to say it's not supposed to end up in the sprays, gels, and lotions you apply to your skin.

But here's where it gets a little muddy: Valisure says there is no established exposure limit regarding benzene in sunscreen or after-sun products. (The FDA temporarily established a 2 ppm limit on benzene in alcohol-based hand sanitizers during the COVD-19 pandemic, but Valisure found that even some of those exceeded that limit). So along with requesting a recall of batches contaminated with benzene, the lab is also asking the FDA to create a "concentration limit" for drug products, including sunscreens (which are regulated as drugs by the FDA), and a "daily exposure limit."

That limit, Valisure says, should be zero. "There is not a safe level of benzene that can exist in sunscreen products," Christopher Bunick, MD, PhD, associate professor of dermatology at Yale University, said in a press release issued by the lab. "Even benzene at 0.1 ppm in a sunscreen could expose people to excessively high nanogram amounts of benzene." (Note: Dr. Bunick tells Health that Valisure asked him to review the petition submitted to the FDA and that he has no financial ties to Valisure.)

As for how the carcinogen made its way into these sunscreen and after-sun product batches, it's believed it was an error in how the product was made—not what it was made from. "It's very likely a contaminant from the manufacturing process," David Light, founder and CEO of New Haven, Connecticut-bases Valisure, tells Health.

And because more than 200 of the 294 batches of sunscreen and after-sun products that Valisure tested had "no detectable levels of benzene," as Light points out, it suggests that it is not necessary for making these products. What's more, it is not safe to do so. Category 1 chemicals, according to Light, are "unacceptable for use in making drugs or inactive ingredients because they are unacceptably toxic."

So what happens now?

Valisure has asked the FDA to investigate the sunscreen and after-sun products in question as well as their manufacturing processes and manufacturer's submissions to the FDA. Health reached out to the FDA for comment. At deadline, the FDA had not provided a response.

It should be said, however, that previous findings from Valisure did lead to an FDA recall. In 2019, the lab's discovery of a carcinogen in the heartburn medication Zantac (ranitidine) prompted the FDA to issue an immediate market withdrawal request for Zantac and generic ranitidine in April 2020.

In a prepared statement, Johnson & Johnson Consumer Health, maker of Neutrogena, noted that the company is committed to making high-quality, safe, and effective sunscreens. "Benzene is not an ingredient in any of our personal care products and we are reviewing the findings presented in this petition," J&J said. The statement included a link to the company's five-step safety assurance process.

CVS Health and Sun Bum did not immediately respond to requests for comment.

The findings, however, shouldn't stop you from using sunscreen. "There's some manufacturing practices apparently that need to be cleaned up, but sunscreen itself is not inherently tied with benzene," Light says.

Benzene was found as a contaminant, not an active ingredient, says Dr. Choi. "Consumers should not worry that this is frequently found in sunscreens."

Adds Dr. Bunick, "Sunscreens are highly effective, when used properly, at preventing sun-induced skin damage, skin lesions, and skin cancers." While consumers should make sure to choose sunscreen or after-sun products that do not contain benzene, he says people shouldn't be scared away from using these products.

"If anything," Dr. Bunick says, "consumers should feel safer that companies like Valisure are checking sunscreen products and calling for improvements in quality."

This story originally appeared on health.com