FDA recall D-0640-2025

Product

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.

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-0640-2025