Key Takeaway

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 by GRACE & FIRE PTY LTD was recalled on August 22, 2025. The hazard: 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...

FDA Drug Class II Ongoing

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

Recalled: August 22, 2025 ~49,275 tubes units affected D-0640-2025

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.

Hazard / Reason

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.

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

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

Drugs

Company Information

GRACE & FIRE PTY LTD

Cremorne, N/A, Australia

View all 2 recalls by GRACE & FIRE PTY LTD →

Distribution

Nationwide in the USA

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Frequently Asked Questions

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