Drug product
Ultra Violette Mini SPF Mates kit includes: Velvet Screen SPF 50 Blurring Mineral SkinScreen, Zinc Oxide 22.75%, 15 mL, 0.5 fl. oz. per tube, Supreme Sunscreen SPF 50, 15 mL 0.5 fl. oz. per tube, Distributed by: Grace & Fire USA Inc., 251 Little Falls Drive, New Castle Wilmington, Delaware 19808, NDC 84803-110-01 (15 mL Velvet Screen), UPC 9355909005757.
D-0641-2025
Product summary
- Event
- Event 97498
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 44,497 tubes
- Official record key
drug-enforcement:D-0641-2025
Official wording
Reason: Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.
Code information: Lot #s: A2453, exp 11/30/2026; A2454, exp 12/31/2026
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Subpotent