FDA Drug recall D-0640-2025
Ultra Violette, Velvet Screen SPF 50, Blurring Mineral Skinscreen, Zinc Oxide 22.75%, a) 15 mL, 0.5 fl. oz. per tube, NDC 84803-106-01, UPC…
- FDA Drug
- Class II
- ongoing
- Published 2025-09-17
On 2025-09-17 the FDA classified a Class II recall of Ultra Violette, Velvet Screen SPF 50, Blurring Mineral Skinscreen, Zinc Oxide 22.75%, a) 15 mL, 0.5 fl. oz. per tube, NDC 84803-106-01, UPC… by Grace And Fire, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0640-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-22 |
| Published | 2025-09-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Grace And Fire |
| Distribution | US |
Product
Ultra Violette, Velvet Screen SPF 50, Blurring Mineral Skinscreen, Zinc Oxide 22.75%, a) 15 mL, 0.5 fl. oz. per tube, NDC 84803-106-01, UPC 9355909006068, b) 50 mL, 1.7 fl. oz. per tube, NDC 84803-106-02, UPC 9355909005924, Distributed by: Grace & Fire USA Inc., 251 Little Falls Drive, New Castle Wilmington, Delaware 19808.
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.
Identifiers
| upc | 9355909006068 |
|---|---|
| upc | 9355909005924 |
| code_info | Lot #s: a) 15 mL tubes: A2455, exp 12/31/2026; b) 50 mL tubes: A2453A, A2453B, exp 11/30/2026; A2454A, exp 12/31/2026; A2550, exp 02/28/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0640-2025%22
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