Drug 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
D-0977-2016
Product summary
- Event
- Event 74138
- Status
- Terminated
- Classification
- Class II
- Quantity
- 37,512 bottles
- Official record key
drug-enforcement:D-0977-2016
Official wording
Reason: Labeling; Product Contains Undeclared API (Oxybenzone)
Code information: CV006V9, 2/2018
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Labeling; Product Contains Undeclared API (Oxybenzone)