Drug product
Beautipharm Eye Care Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4%) Eye cream, 1 oz. Net. Wt. 30 ml bottle, Art. 03190 Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany. UPC 4 035219 031909.
D-1099-2017
Product summary
- Event
- Event 77840
- Status
- Terminated
- Classification
- Class III
- Quantity
- 73 balms
- Official record key
drug-enforcement:D-1099-2017
Official wording
Reason: Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Code information: Lot #: 280318, Exp 03/28/2018; 020918, Exp 09/02/2018; 131019, Exp 10/13/19
Distribution pattern: Distributed throughout the United States
Derived failure modes
-
Potency or specification failure
Subpotent