THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 50ML - 1.7 fl. o
Summary
The FDA issued a Class II for THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocryle by Allies Group Inc.. Reason: Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label..
Details
Source
Drug Recall
External ID
D-0823-2026
Action Date
2026-09-09
Status
Ongoing
Category
drug
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/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 Affected: 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.
Distribution
Nationwide within the U.S.A
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-14
Company
Wilmington, DE
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 53 drug recalls issued in the same week, part of 66 drug-related FDA actions this month.
Allies Group Inc. has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Allies Group Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Allies Group Inc. have FDA actions?
Allies Group Inc. has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0823-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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