Ultra Violette, Velvet Screen SPF 50, Blurring Mineral Skinscreen, Zinc Oxide 22.75%, a) 15 mL, 0...
FDA Recall #D-0640-2025 — Class II — August 22, 2025
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.
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.
Recalling Firm
GRACE & FIRE PTY LTD — Cremorne, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
49,275 tubes
Distribution
Nationwide in the USA
Code Information
Lot #s: a) 15 mL tubes: A2455, exp 12/31/2026; b) 50 mL tubes: A2453A, A2453B, exp 11/30/2026; A2454A, exp 12/31/2026; A2550, exp 02/28/2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated