Why it was 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.
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.
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0640-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 22, 2025
- FDA report date
- Sep 17, 2025
- Quantity
- 49,275 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- GRACE & FIRE PTY LTD
Original FDA data
Every field from FDA enforcement report D-0640-2025, exactly as published.
Show all FDA fields
- City
- Cremorne
- Status
- Ongoing
- Country
- Australia
- Event ID
- 97498
- Address
- 19 Dover Street
- 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
- Report date
- Sep 17, 2025
- Product type
- Drugs
- Recall number
- D-0640-2025
- Classification
- Class II
- Recalling firm
- GRACE & FIRE PTY LTD
- Product quantity
- 49,275 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 22, 2025
- Initial firm notification
- Letter
- Center classification date
- Sep 11, 2025