FDA-Drug2016-06-15Class II

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

Bayer Health Care LLC
Hazard

Labeling; Product Contains Undeclared API (Oxybenzone)

Sold states
Nationwide
Affected count
37,512 bottles
Manufactured in
4207 Michigan Avenue Rd NE, N/A, Cleveland, TN, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0977-2016

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