Bayer Recalls Coppertone Sunscreen Lotion for Undeclared Oxybenzone
Bayer Health Care LLC is recalling 37,512 bottles of Coppertone Sunscreen Lotion, Clearly Sheer, Broad Spectrum SPF 50, because the product contains undeclared Oxybenzone.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (undeclared API) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Bayer Health Care LLC is voluntarily recalling 37,512 bottles of Coppertone Sunscreen Lotion, Clearly Sheer, Broad Spectrum SPF 50, 5 fl oz (147 mL). The recall was initiated because the product contains an undeclared active pharmaceutical ingredient (API), specifically Oxybenzone.
The affected product is distributed nationwide. The specific lot code is CV006V9, with a manufacturing date of 2/2018. The product is identified by NDC 11523-7391-1 and UPC 00041100005762.
Consumers who have this product should stop using it and return it to the place of purchase for a refund or contact Bayer Health Care LLC for further instructions.
The recalled product
- Product
- Coppertone SUNSCREEN LOTION, CLEARLY SHEER, BROAD SPECTRUM SPF 50, 5 FL OZ (147mL), OTC, Dist by: Bayer HealthCare LLC, Whippany, NJ 07981 --- NDC 11523-7391-1, UPC 00041100005762
- Manufacturer
- Bayer Health Care LLC
- Affected units
- 37,512
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- CV006V9
- 2/2018
Distribution
Distributed nationwide across the United States.
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