Comments Offer Perspectives on Coppertone Recall

Coppertone, owned by Beiersdorf, has voluntarily recalled 12 lots of its aero- sol sunscreen spray products manufactured between January 10, 2021, and June 15, 2021, after identifying the presence of benzene, a human carcinogen, in the specific product lots. No other Coppertone products were included in the recall.

The recall¹ covers lots of 5 of its aerosol sunscreen products: Pure & Simple SPF 50 Spray (2021 Launch), Sport Mineral SPF 50 Spray (2021 Launch), and Travel-Size Coppertone® Sport Spray SPF 50 (1.6 oz.), according to a company statement published on the FDA’s website September 30, 2021.²

This is the latest development in a story that began in late May. At that time, Valisure, an independent lab dedicated to batch testing medications before they reach consumers, released test data showing detectable levels of benzene in 27% of the 294 unique batches of sun care products from 69 different companies. The lab found 78 different sunscreen and after-sun care products contained benzene.

See details of the headline news broken by Dermatology Times®, here.

Only 1 of the Coppertone products Valisure analyzed in the initial testing had traces of benzene below 0.1 parts per million (ppm); the other 10 products had no detectable benzene, according to David Light, founder and CEO of Valisure, in New Haven, Connecticut.

“However, we didn't have the opportunity to test any of the sunscreen products that are currently part of the Coppertone recall,” Light told Dermatology Times® in an October 9, 2021, interview. He noted that this recall “mostly involved mineral based products where zinc oxide is the active ingredient.” Since, in his view, “There doesn't appear to be a mechanism where the zinc could be the source of benzene,” the search for the source of the contamination is likely to turn toward raw materials or inactive ingredients.

Benzene is classified as a human carcinogen, according to the FDA.¹ Exposure to this carcinogen can happen through inhalation, orally, and through the skin. Also, depending on the extent and level of exposure, benzene exposure could lead to an increased risk of blood cancers such as leukemia, blood cancer of the bone marrow and other blood disorders. 

The FDA advises consumers to stop using the products¹ listed in the recall and dispose of them appropriately. 

When asked for comment, Coppertone told Dermatology Times®, “Based on generally accepted exposure modeling by numerous regulatory agencies [including the FDA], daily exposure to benzene levels detected in the Coppertone aerosol sunscreen sprays that are part of this voluntary recall would not be expected to cause adverse health consequences; however, consumers should stop using these specific Coppertone aerosol sunscreen spray products that are part of this voluntary recall and dispose of them appropriately.” 

Christopher Bunick, MD, PhD, associate professor of dermatology at Yale University and member of Dermatology Times®’ editorial advisory board, has a different viewpoint. “There is not a safe level of benzene in sunscreen,” he said, noting the need for repeated application.

Coppertone is the second sunscreen giant to issue a recall based on findings of benzene in certain product lots. In July, Johnson & Johnson Consumer Inc (JCCI) voluntarily recalled 4 Neutrogena and 1 Aveeno spray sunscreen products³ after internal testing identified low levels of benzene in these product lots.

“I do not believe that consumers should panic. It is to be expected over the coming months that as companies complete their internal investigations, more products that are verified to have benzene contamination will be recalled. This actually is a positive sign that companies took the original Valisure findings seriously and are working towards rectifying the problem,” said Bunick. “I think in today's fast-paced world we forget that these quality control measures do take time and proper study. Coppertone, like JJCI before it, should be commended for putting patient safety first.”

Will the proactive recalls suffice to reassure consumers about sunscreen safety? 
“Dermatologists should remind their patients that Valisure identified many batches of sunscreens without benzene contamination, so there are safe options available for continuing sunscreen protection,” Bunick told Dermatology Times®. “This fact alone should reassure patients and minimize panic. Ultimately, I believe the best way to inform patients is always with the truth--simply tell them that some, not all, sunscreens were found to have benzene contamination, which is linked to increased risk of cancer, and the entire sunscreen industry is working towards fixing the problem, which means a series of recalls is expected over the coming months.”

Asked whether he sees this issue impacting compliance, Bunick said, “​I don't think sunscreen compliance is going to decrease honestly. Sunburns hurt. Patients don't like the feel of a sunburn and will take measures to protect themselves. In the short term, this could mean increased use of hats and sun-protective clothing. Long term, I actually foresee sunscreen compliance increasing because dermatologists and manufacturers will now be able to say, ‘We identified a problem, we listened to patient concerns, and we made sunscreens and quality control of our products safer than ever.’ To me this message will reassure patients and lead to increased long-term compliance.”

Coppertone added, “While we cannot provide medical advice to dermatologists or their patients, we certainly agree with the FDA and other medical authorities on the importance of using of sunscreen, along with other protective measures.”

The FDA’s proposed revisions and updates⁴ to the requirements regarding maximum sun protection (SPF) values, active ingredients, broad spectrum requirements and product labeling that would make important product information more prominent for consumers.

“In the most recent FDA announcement, there are overall labeling changes proposed that impact the front and back panels of sunscreen labels,” Coppertone told Dermatology Times®. These proposed changes will have a comment period of 45 days, then go into effect a year after the final order is issued.”

According to Bunick, this recall by another major sunscreen not only independently verified Valisure’s findings, but “speaks directly to the need for timely, accurate FDA assessment of and action on the benzene contamination issue.”

“There really is only 1 appropriate action here, for the safety of all patients, and that is to identify the supply chain and manufacturing problem allowing benzene contamination and fix it,” he added. “The FDA can reassure dermatologists and patients by clearly delineating the root cause in a transparent manner. There are many sunscreens without benzene contamination, so it does not have to be there.”

More dermatologists may be looking to the FDA for guidance or further action as recalls broaden. In an October 1, 2021, recall, Bayer U.S. Inc voluntarily recalled all unexpired antifungal Lotrimin® AF and Tinactin® spray products with lot numbers beginning with TN, CV, or NAA, distributed between September 2018 to September 2021, to the consumer level, citing presence of benzene in some samples of the products. 

In its press release⁵ posted on the FDA’s website, the company pointed out that benzene is not an ingredient in any of Bayer Consumer Health products. “It is important to note that Bayer’s decision to voluntarily recall these products is a precautionary measure and that the levels detected are not expected to cause adverse health consequences in consumers,” according to the statement. Bayer pointed out, “There are no issues of concern with Lotrimin®/Tinactin® creams, including Lotrimin® Ultra, or any other Bayer products. The recalled products are all packaged in aerosol spray cans.” 

Suncreens are not the only products addressing benzene contamination concerns. The FDA issued a statement⁶ October 4, 2021, that it had found “unacceptable levels of benzene, acetaldehyde, and acetal contaminants” in certain artnaturals scent-free hand sanitizer labed with “DIST. by artnaturals Gardena, CA 90248”. The FDA urges consumers not to use this contaminated product and has added artnaturals hand sanitizer products to the list⁶ of hand sanitizers consumers should not use.

Earlier this year, Valisure detected benzene in specific batches of various brands of hand sanitizers. Scentsational Soaps & Candles voluntarily recalled⁷ 5 lots of its Scentsational Soaps & Candles scented hand sanitizers from the Black and White Collection and Photo Real Collection as well as 3 lots of Ulta Beauty Collection hand sanitizers packaged in 3.38- and 3.4 fluid ounce spray bottles, respectively, to the consumer level.

The FDA announced⁸ October 12, 2021 that it will withdraw temporary guidances for alcohol-based hand sanitizers as effective December 31, 2021. Those guidances were issued in March 2020 for non-drug manufacturers to produce certain alcohol-based hand sanitizers to meet demand related to the public health emergency sparked by COVID-19. Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, noted in the statement that, since supply has increased to meet consumer and health care provider demand, the FDA “determined it’s appropriate to withdraw the guidances” and allow manufacturers “time to adjust their business plans related to production of these products under those temporary policies.”

Light sees these takeaways. “Regarding FDA actions, we certainly hope these and other recent recalls for benzene contamination prompt the FDA to take more action on this overall issue with consumer healthcare products, both over the counter drugs and cosmetics,” said Light. “We are still waiting for FDA to fill the current regulatory gap on benzene where a limit of 2 ppm is only defined for emergency situations and drug products that constitute a ‘significant therapeutic advance’ and require benzene for their manufacture; none of which appears to apply to sunscreen.” In his view, even a very low concentration of benzene in a product like sunscreen “quickly adds up to a very high total exposure, since the proper application of sunscreen can use high volumes of product. Therefore, a daily exposure limit for benzene in standard products needs to be established.” 

More information on the Coppertone product recall, including images, lot information, and refund requests can be found at www.sunscreenrecall2021.com.

Product images and information on which lot numbers fall under the Bayer recall are available at: https://livewell.bayer.com/document/2011.

Disclosures

Bunick reported being a consultant/advisor for Almirall, Sanofi and Regeneron, UCB, and Skinosive. He also reported being a speaker for UCB, Almirall, and Allergan. Bunick has also been a research investigator for Almirall.

Light is the founder and CEO of Valisure.

References

1. https://www.dermatologytimes.com/view/coppertone-recalls-12-lots-of-aerosol-sunscreen. Published October 1, 2021. Accessed October 13, 2021.
2. FDA. Coppertone® Issues Voluntary Nationwide Recall of Specific Lots of Pure & Simple SPF 50 Spray (2021 Launch), Sport Mineral SPF 50 Spray (2021 Launch), and Travel-Size Coppertone® Sport Spray SPF 50 (1.6OZ) Aerosols Sunscreen Sprays Due to the Presence of Benzene. Published September 30, 2021. Acessed October 13, 2021. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/coppertoner-issues-voluntary-nationwide-recall-specific-lots-pure-simple-spf-50-spray-2021-launch?utm_medium=email&utm_source=govdelivery
3. https://www.dermatologytimes.com/view/johnson-johnson-recalls-5-aerosol-sunscreen-brands-with-benzene-traces. Published July 15, 2021. Accessed October 13, 2021
4. https://www.dermatologytimes.com/view/fda-announces-action-on-sunscreens. Published September 24, 2021. Accessed October 13, 2021.
5. FDA. Bayer Issues Voluntary Recall of Specific Lotrimin® and Tinactin® Spray Products Due to the Presence of Benzene. Published October 1, 2021. Accessed October 13, 2021.
6. FDA. FDA updates on hand sanitizers consumers should not use. Published October 4, 2021. Accessed October 13, 2021.https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use
7. FDA. Scentsational Soaps & Candles, Inc. Issues Voluntary Nationwide Recall of Scented Hand Sanitizers Due to the Presence of Methanol (Wood Alcohol), Benzene and Acetaldehyde. Published April 28, 2021. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/scentsational-soaps-candles-inc-issues-voluntary-nationwide-recall-scented-hand-sanitizers-due
8. FDA. FDA In Brief: FDA Withdrawing Temporary Guidances for Alcohol-Based Hand Sanitizers. Published October 12, 2021. Accessed October 13, 2021.