Class IIDrug
The One Spf 50 Invisible Sunscreen Gel recall
Summary
Allies Group Inc. is recalling THE ONE SPF 50 INVISIBLE SUNSCREEN GEL (drug). According to the FDA report, the reason is: Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label. The FDA rated this a Class II: the product may cause temporary or medically reversible health problems; serious harm is unlikely. Recall status: Ongoing.
Details from the FDA report
- Product
- THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 90ml - 3 fl. oz. Tube, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 075853
- Reason
- Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
- Lot / code info
- Lots: G23W03B, Exp. 8/4/2027; A16X02, Exp. 1/20/2029: A16X03, Exp. 1/22/2029.
- Quantity
- 2,149 90mL-Tubes
- Distribution
- Nationwide within the U.S.A
- Recalling company
- Allies Group Inc., Wilmington, DE United States
- Recall started
- August 14, 2026
- FDA report date
- September 9, 2026
- Classification
- Class II: The product may cause temporary or medically reversible health problems; serious harm is unlikely.
- Voluntary / mandated
- Voluntary: Firm initiated
- Status
- Ongoing
- Recall number
- D-0826-2026
What to do
- Check whether you have this product, and compare the lot numbers, codes, or dates on your package with the codes listed above.
- If it matches, stop using it and keep it away from children and pets.
- Contact the recalling company (Allies Group Inc.) or the store where you bought it about returns or refunds.
- Do not stop a prescribed medication without first talking to your pharmacist or doctor; they can help find a safe replacement.
- If you think the product made you or someone else sick, contact a doctor or pharmacist. In an emergency call 911.
- You can report problems to the FDA via MedWatch.