Drug product
Humanrace Suncare, Ozone Body Protection Cream, Broad Spectrum Sunscreen SPF 30, packaged as a 148mL (5 fl oz.) bottle, PA ++++, 100% mineral, Active Ingredient: Zinc oxide 15%, Snow Mushroom, Squalene, Aloe, Dist. By: @Humanrace 2022 Beverly Hills, CA 90210, USA, NDC 82779-002
D-1176-2023
Product summary
- Firm
- HUMANRACE
- Event
- Event 92954
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2942 units
- Official record key
drug-enforcement:D-1176-2023
Official wording
Reason: Subpotent Drug: Product does not contain SPF that is declared on the label.
Code information: Lot #: 1752A, 1752B, 1782E, 1782G, 1782C, 1752C, 1782B; Exp. 06/2024.
Distribution pattern: Nationwide in the USA, Spain, Italy, UK, and France.
Derived failure modes
-
Potency or specification failure
Subpotent