Checked
Class IIDrug recallOngoing
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL recall
Recalled by Allies Group Inc. of Wilmington, DE · FDA report 09/09/2026
Not an official recall notice and may be delayed. Confirm with the manufacturer or the agency.
- Class
- Class II
- Moderate
- Status
- Ongoing
- Recall started
- 08/14/2026
- Distribution
- Nationwide
Reason for recall
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Class II: Use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
Recalled product
- Product
- 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 and code info
- 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.
- Quantity
- 29,014 50mL Tubes
- Recall number
- D-0823-2026
- Event ID
- 99652
- Initiated by
- Voluntary: Firm initiated
Where it was distributed
Nationwide within the U.S.A
- Nationwide
Recall timeline
- 08/14/2026Firm started the recall
- 08/31/2026FDA classified it as Class II
- 09/09/2026Published in the FDA enforcement report
All products in this recall
4 products under event 99652
- D-0823-2026THE 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... This page
- D-0824-2026THE 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...
- D-0825-2026THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 20ml - 0.7 fl. oz. Tube, Made in the U.S.A...
- D-0826-2026THE 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...
Frequently asked questions
- Why was THE ONE SPF 50 INVISIBLE SUNSCREEN GEL recalled?
- Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
- What does Class II mean?
- Class II is FDA's moderate recall category: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
- Where was the recalled product sold?
- Nationwide within the U.S.A
- Is this recall still active?
- The FDA lists the recall as ongoing. The recall is still in progress.
Source: U.S. Food and Drug Administration, openFDA enforcement report · Last updated 09/09/2026 · Do not rely on openFDA to make decisions regarding medical care