Recalls / Class II

Class IID-0640-2025

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.

Affected lot / 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

Why it was recalled

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.

Recalling firm

Firm

GRACE & FIRE PTY LTD

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

19 Dover Street, N/A, Cremorne, N/A N/A, Australia

Distribution

Quantity

49,275 tubes

Distribution pattern

Nationwide in the USA

Timeline

Recall initiated

2025-08-22

FDA classified

2025-09-11

Posted by FDA

2025-09-17

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0640-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.