Drug product
EcoLips Sport Lip Balm, SPF 30, Avobenzone (5%), Octinoxate (10%), Octisalate (5%), Net Wt. 0.15 oz. (4.25g) tube, Eco Lips, Inc., Marion, IA 52302, UPC: 859623000030; 859623000177; 859623000573; Display UPC: 859623000092; 859623000108; 859623000139; 859623000146; 859623000184; 859623000535; 859623001037.
D-1310-2020
Product summary
- Firm
- Eco Lips Inc
- Event
- Event 85774
- Status
- Terminated
- Classification
- Class II
- Quantity
- 68,400 tubes
- Official record key
drug-enforcement:D-1310-2020
Official wording
Reason: Superpotent Drug: The active ingredient, avobenzone, is used at 5% which is higher than the allowable 3% in the sunscreen formula per FDA sunscreen regulations.
Code information: Lot #s: S-17-157, S-17-163C, Exp. 06/30/2020; S-17-187, S-17-S194, Exp. 07/31/2020; S-17-262, S-17-271, Exp. 09/30/2020; S-17-339, Exp. 12/31/2020; S-18-029, Exp. 01/31/2021; S-18-044, Exp. 02/28/2021; S-18-072, Exp. 03/31/2021; S-18-116, Exp. 04/30/2021; S-18-145, Exp. 05/31/2021; S-18-227, Exp. 08/31/2021; S-18-355, Exp. 12/31/2021; 00003 19081, Exp. 03/31/2022; 00003 19304, Exp. 11/30/2022.
Distribution pattern: Nationwide within the US.
Derived failure modes
-
Potency or specification failure
Superpotent