Drug product
Higher Education Make Out Ready Vegan Lip Balm, SPF 15, Net Wt. 0.15 oz (4.25 g) per tube, Active Ingredients: Oxtinoxate (7.5%), Oxybenzone (3%); Distributed by: Higher Education Skincare, 1.833.251.0388
D-0890-2022
Product summary
- Firm
- Eco Lips, Inc
- Event
- Event 90197
- Status
- Terminated
- Classification
- Class III
- Quantity
- 17,000 units
- Official record key
drug-enforcement:D-0890-2022
Official wording
Reason: Mislabeling: The active ingredient list on the label does not match the product's actual ingredients Specifically, the label states Octinoxate 7.5% and Oxybenzone 3%, while the product therein is made with Octinoxate 7.5%, Octisalate 5%, Octocrylene 5%, and Avobenzone 3%.
Code information: Lot 93400-21200
Distribution pattern: CA
Derived failure modes
-
Labeling or packaging
Mislabeling