Johnson & Johnson Issues Voluntary Recall of Aerosol Sunscreen Products

Press Release From FDA

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sunscreen recall

Johnson & Johnson Consumer Inc. (JJCI) is voluntarily recalling all lots of five NEUTROGENA® and AVEENO® aerosol sunscreen product lines to the consumer level. Internal testing identified low levels of benzene in some samples of the products. Consumers should stop using the affected products and follow the instructions set forth below.

The only sunscreen products impacted are aerosol products, specifically:

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.

Product images and lot information is available on www.Neutrogena.com and www.Aveeno.com.

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 testing would not be expected to cause adverse health consequences. Out of an abundance of caution, the FDA is recalling all lots of these specific aerosol sunscreen products.

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.

Sunscreen use is critical to public health. 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.

The recalled sunscreen products are packaged in aerosol cans. The products were distributed nationwide through a variety of retail channels.

Consumers should stop using these specific products and appropriately discard them. Consumers may contact the JJCI Consumer Care Center 24/7 with questions or to request a refund by calling 1-800-458-1673. Consumers should 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
Regular Mail or Fax: Download form 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 knowledge of the U.S. Food and Drug Administration.

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