GRACE & FIRE PTY LTD: Drug Recall

Recall #D-0641-2025 · 08/22/2025

Class II: Risk

Recall Details

Recall Number
D-0641-2025
Classification
Class II
Product Type
Drug
Recalling Firm
GRACE & FIRE PTY LTD
Status
Ongoing
Date Initiated
08/22/2025
Location
Cremorne, N/A, Australia
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
44,497 tubes

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.

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.

Distribution Pattern

Nationwide in the USA

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.