Drug product
Beautipharm All Day Moisturizing Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4%) Facial Cream, 1.66 oz. Net. Wt. 50 ml bottle, Art. 03120 Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany. UPC 4 035219 032005.
D-1097-2017
Product summary
- Event
- Event 77840
- Status
- Terminated
- Classification
- Class III
- Quantity
- 478 balms
- Official record key
drug-enforcement:D-1097-2017
Official wording
Reason: Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Code information: Lot #: 240817, Exp 08/24/17; 061217, Exp 12/06/17; 290318, Exp 03/29/18; 160818, Exp 08/16/18; 231118, Exp 11/23/18; 160119, Exp 01/16/19; 080819, Exp 08/08/19
Distribution pattern: Distributed throughout the United States
Derived failure modes
-
Potency or specification failure
Subpotent