FDA recall D-0641-2025

GRACE & FIRE PTY LTD · Class II · drug

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.

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.

Distribution

Nationwide in the USA

Key facts

Status: Ongoing
Initiation date: 2025-08-22
Report date: 2025-09-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Cremorne, N/A, Australia

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0641-2025