Drug product
Beautipharm Body Moisturizing Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4%) Body Lotion, 8.3 oz. Net. Wt. 250 ml bottle, Art. 03150 Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany. UPC 4 035219 031503.
D-1098-2017
Product summary
- Event
- Event 77840
- Status
- Terminated
- Classification
- Class III
- Quantity
- 105 creams
- Official record key
drug-enforcement:D-1098-2017
Official wording
Reason: Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Code information: Lot #: 201017, Exp 10/20/17; 290618, Exp 06/29/18; 040419, Exp 04/04/19.
Distribution pattern: Distributed throughout the United States
Derived failure modes
-
Potency or specification failure
Subpotent