| MedWatch - The FDA Safety Information and Adverse Event Reporting Program | | | TOPIC: Banana Boat Hair & Scalp Sunscreen by Edgewell Personal Care: Recall - Due to the Presence of Benzene AUDIENCE: Consumer, Health Professional, Pharmacy, Dermatology ISSUE: Edgewell Personal Care is recalling three batches of Banana Boat Hair & Scalp Sunscreen Spray SPF 30 because an internal review found that some samples of the product contained trace levels of benzene. While benzene is not an ingredient in any Banana Boat products, the review showed that unexpected levels of benzene came from the propellant that sprays the product out of the can. Benzene is classified as a human carcinogen. Exposure to benzene can occur by inhalation, orally, and through the skin and it potentially can result in cancers including leukemia and blood cancer of the bone marrow and blood disorders which can be life threatening. Benzene is ubiquitous in the environment. Humans around the world have daily exposures to it indoors and outdoors from multiple sources. Daily exposure to benzene in the recalled products would not be expected to cause adverse health consequences according to an independent health assessment using established exposure modeling guidelines. To date, Edgewell has not received any adverse events related to this recall. For more information about this recall, click on the red button "Read Recall" below. RECOMMENDATIONS: - 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.
- Consumers should stop using the affected product immediately and appropriately discard.
- Consumers with questions regarding this recall may contact the company.
| | Health professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: - Complete and submit the report online.
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.
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