The Recall Desk

FDA (Drugs) recall action 97498

GRACE & FIRE PTY LTD recalled 2 products on 2025-09-17

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2025-09-17
Critical
0
Units
93,772

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Drugs)··2025-09-17

    Mini sunscreen kits recalled after SPF testing produced inconsistent results

    Ultra Violette Mini SPF Mates kits are recalled nationwide after testing of the SPF 50 sunscreen produced inconsistent results ranging from SPF 4 to 64. 44,497 tubes are affected.

    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 Wilmingto
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2025-09-17

    Mineral sunscreen recalled after SPF testing ranged from 4 to 64

    Ultra Violette Velvet Screen SPF 50 mineral sunscreen is recalled nationwide after testing produced inconsistent SPF results ranging from SPF 4 to 64. 49,275 tubes are affected.

    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
    Category
    Distribution
    0 states