Drug product
Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm (Oxybenzone 5%, Meradimate 5%, Octinoxate 7.5%, Octisalate 5%) 0.15 Oz Tube, Rocky Mtn. Sunscreen, UPC 7 54018 20004 3
D-1540-2020
Product summary
- Event
- Event 85814
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,558 pieces
- Official record key
drug-enforcement:D-1540-2020
Official wording
Reason: Superpotent Drug: Active Ingredient Octisalate found at 15% above label claim.
Code information: Part ID 9PRKY01, Batch #13852
Distribution pattern: Shipped to one distributer located in Colorado
Derived failure modes
-
Potency or specification failure
Superpotent