FDA Recall D-0641-2025

GRACE & FIRE PTY LTD · Cremorne, N/A

Class II Ongoing 265 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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.

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

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.

Recall record

Recall number: D-0641-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2025-08-22
Classified by FDA Center: 2025-09-11
FDA published: 2025-09-17
Recalling firm: GRACE & FIRE PTY LTD
Firm location: Cremorne, N/A, Australia

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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