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%), 3ml - 0.1 fl. oz, Sachet: Single use only, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914.UPC 8 885014 073293
Lot numbers, UPCs & expiration codes
Lots: C13W01A, Exp. 3/27/2027; G23W01A, Exp. 7/24/2027; M04W01, Exp. 12/10/2028.
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-0824-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 14, 2026
- FDA report date
- Sep 9, 2026
- Quantity
- 27,492 3mL Sachets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Allies Group Inc.
Original FDA data
Every field from FDA enforcement report D-0824-2026, 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: C13W01A, Exp. 3/27/2027; G23W01A, Exp. 7/24/2027; M04W01, Exp. 12/10/2028.
- Postal code
- 19801-1120
- Report date
- Sep 9, 2026
- Product type
- Drugs
- Recall number
- D-0824-2026
- Classification
- Class II
- Recalling firm
- Allies Group Inc.
- Product quantity
- 27,492 3mL Sachets
- 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%), 3ml - 0.1 fl. oz, Sachet: Single use only, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914.UPC 8 885014 073293
- Distribution pattern
- Nationwide within the U.S.A
- Recall initiation date
- Aug 14, 2026
- Initial firm notification
- Letter
- Center classification date
- Aug 31, 2026