GRACE & FIRE PTY LTD: Drug Recall

Recall #D-0640-2025 · 08/22/2025

Class II: Risk

Recall Details

Recall Number: D-0640-2025
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: 49,275 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, 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.

Distribution Pattern

Nationwide in the USA

Other Recalls by GRACE & FIRE PTY LTD

Class II: Risk 08/22/2025

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.

View all recalls by GRACE & FIRE PTY LTD →

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.