Johnson & Johnson Recalls 5 Aerosol Sunscreen Brands with Benzene Traces

Johnson & Johnson Consumer Inc (JJCI) voluntarily recalled all lots of 5 NEUTROGENA® and AVEENO® aerosol sunscreen and after-care sunscreen product lines yesterday citing internal test results that identified traces of benzene, a human carcinogen, in some samples of these products. The company advised consumers to stop using the affected products immediately.

The recall includes only these products, noted the press release:

• NEUTROGENA® Beach Defense® aerosol sunscreen,
• NEUTROGENA® Cool Dry Sport aerosol sunscreen,
• NEUTROGENA® Invisible Daily™ defense aerosol sunscreen,
• NEUTROGENA® Ultra Sheer® aerosol sunscreen, and
• AVEENO® Protect + Refresh aerosol sunscreen.

The move comes less than seven weeks after Dermatology Times® broke the news that Valisure, a pharmacy dedicated to batch testing medications before they reach consumers, found detectable levels of benzene in 78 sunscreen and after-care sunscreen products. Valisure’s laboratory test examined 294 unique batches of sun care products from 69 companies. Results showed 27% of the samples tested contained detectable levels of benzene. However, other batches exceeded the FDA concentration limit of 2 parts per million by up to 3 times.

This is not the first time Valisure has identified harmful contaminants in consumer products. In March, it released a Citizen Petition asking the FDA to recall various brands of hand sanitizer after detecting benzene contamination in multiple batches.

Watch our interview with Valisure Founder and CEO David Light, here.

As pointed out in the Dermatology Times® report, according to the U. S. Center for Disease Control and Prevention (CDC), the World Health Organization (WHO), U.S. Department of Health and Human Services, and various other regulatory agencies, benzene is known to cause cancer in humans. The National Institute for Occupational Safety and Health (NIOSH) also defines benzene as a carcinogen and exposure can include “inhalation, skin absorption, ingestion, and skin and/or eye contact.”

Benzene has been associated with blood cancers such as leukemia. What makes these findings "particularly concerning", according to Valisure, is that these products are absorbed through the skin and multiple studies conducted by FDA researchers have shown chemicals in sunscreen products are found in the blood at high levels following skin application.

Get a physician’s perspective from Christopher Bunick, MD, and Dermatology Times® editorial board member.

Johnson & Johnson outlined its position in the press release. “Benzene is classified as a human carcinogen, a substance that could potentially cause cancer depending on the level and extent of exposure. Benzene is ubiquitous in the environment. Humans around the world have daily exposures indoors and outdoors from multiple sources. Benzene can be absorbed, to varying degrees, by inhalation, through the skin, and orally. Based on exposure modeling and the Environmental Protection Agency's (EPA) framework, daily exposure to benzene in these aerosol sunscreen products at the levels detected in our testing would not be expected to cause adverse health consequences. Out of an abundance of caution, we are recalling all lots of these specific aerosol sunscreen products,” according to the statement.

“While benzene is not an ingredient in any of our sunscreen products, it was detected in some samples of the impacted aerosol sunscreen finished products. We are investigating the cause of this issue, which is limited to certain aerosol sunscreen products,” the company added.

Physicians such as Christopher Bunick, MD, PhD, associate professor of dermatology at Yale University and member of Dermatology Times®’ editorial advisory board, see this pre-emptive move as important.

“This sunscreen recall by Johnson & Johnson most importantly means that the company is taking consumer health and product safety very seriously,” Bunick told Dermatology Times®. “This is a good thing. The fact they are recalling specific sunscreens suggests their independent testing has corroborated Valisure’s initial research which brought the benzene contamination issue to the forefront. Johnson & Johnson has now set an example for other sunscreen manufacturers to perform their own product safety analysis and transparently produce those results to the public.”

The FDA has not issued any directives as of press time. “I expect the FDA will carefully evaluate Johnson & Johnson’s findings in comparison with Valisure’s,” said Bunick. “I believe they will work with manufacturers to continue to try to identify the source of the benzene contamination, and going forward, implement measures to ensure consumers have access to benzene-free sunscreens.”

In the meantime, Johnson & Johnson recommended that consumers stop using the specific products listed above and “appropriately discard them”.

The press release also advised consumers to contact the JJCI Consumer Care Center 24/7 with questions or to request a refund by calling 1-800-458-1673 and contact their physician or healthcare provider if they have any questions, concerns or have experienced any problems related to using these aerosol sunscreen products. JJCI is also notifying its distributors and retailers by letter and is arranging for returns of all recalled products.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the FDA’s knowledge.

Click the documents below to find out which products contain and do not contain benzene, as well as tips for responsible disposal of potentially contaminated products.

• List of products where benzene was detected.
• List of products where benzene was not detected.
• Responsible Disposal of Potentially Contaminated Products.

Johnson & Johnson included a statement on the importance of continuing to use sunscreen. "Sunscreen use is critical to public health," the company stated in the press release. "Melanoma incidences continue to increase worldwide, and the majority of cases are caused by excessive sun exposure. It is important that people everywhere continue to take appropriate sun protection measures, including the continued use of alternative sunscreen."

Check back for the latest updates on this story on Dermatology Times.