Why it was recalled
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Product description
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 50ML - 1.7 fl. oz Tube, Made in U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 073224
Lot numbers, UPCs & expiration codes
Lots: H22V01 Exp. 8/29/2026, H22V02 Exp. 8/30/2026, K22V02A Exp. 10/29/2026, M10V01 Exp. 01/21/2027, G23W02B Exp. 7/25/2027, G23W03 Exp. 8/4/2027, G23W03D Exp. 8/4/2027, K10W01A Exp. 10/17/2028, K10W01C Exp. 10/17/2028, M11W02 12/17/2028, F09X02 Exp. 6/17/2029.
Where it was sold
Nationwide within the U.S.A
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-0823-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 14, 2026
- FDA report date
- Sep 9, 2026
- Quantity
- 29,014 50mL Tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Allies Group Inc.
Original FDA data
Every field from FDA enforcement report D-0823-2026, exactly as published.
Show all FDA fields
- City
- Wilmington
- State
- DE
- Status
- Ongoing
- Country
- United States
- Event ID
- 99652
- Address
- 1209 N Orange St
- Code information
- Lots: H22V01 Exp. 8/29/2026, H22V02 Exp. 8/30/2026, K22V02A Exp. 10/29/2026, M10V01 Exp. 01/21/2027, G23W02B Exp. 7/25/2027, G23W03 Exp. 8/4/2027, G23W03D Exp. 8/4/2027, K10W01A Exp. 10/17/2028, K10W01C Exp. 10/17/2028, M11W02 12/17/2028, F09X02 Exp. 6/17/2029.
- Postal code
- 19801-1120
- Report date
- Sep 9, 2026
- Product type
- Drugs
- Recall number
- D-0823-2026
- Classification
- Class II
- Recalling firm
- Allies Group Inc.
- Product quantity
- 29,014 50mL Tubes
- Reason for recall
- Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 50ML - 1.7 fl. oz Tube, Made in U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 073224
- Distribution pattern
- Nationwide within the U.S.A
- Recall initiation date
- Aug 14, 2026
- Initial firm notification
- Letter
- Center classification date
- Aug 31, 2026