Recalls / Class II

Class IID-0641-2025

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.

Affected lot / code info

Lot #s: A2453, exp 11/30/2026; A2454, exp 12/31/2026

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

44,497 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-0641-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.