D-0641-2025 Class II Ongoing

Recalled by GRACE & FIRE PTY LTD — Cremorne, N/A

Recall Details

Product Type
Drugs
Report Date
September 17, 2025
Initiation Date
August 22, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
44,497 tubes

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Nationwide in the USA

Code Information

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