Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0824-2026·Announced 2026-09-09

Allies Group Recalls Subpotent SPF 50 Sunscreen Gel Sachets

Allies Group Inc. is recalling 27,492 sachets of THE ONE SPF 50 Invisible Sunscreen Gel because firm testing indicated the product may not reliably provide the stated SPF 50 protection.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a subpotent product where the stated protection level may not be achieved. No illnesses or injuries are reported, and the risk is theoretical rather than an immediate physical hazard like choking or fire, fitting the Moderate criteria for low-risk contamination or labeling/efficacy issues.

Plain-English summary

Allies Group Inc. is recalling 27,492 3mL sachets of THE ONE SPF 50 Invisible Sunscreen Gel. The product contains Avobenzone 3%, Homosalate 7%, Octocrylene 10%, and Octisalate 5%. The affected lots are C13W01A (Exp. 3/27/2027), G23W01A (Exp. 7/24/2027), and M04W01 (Exp. 12/10/2028). The product was distributed nationwide within the U.S.A.

The recall was initiated because firm testing indicated that the affected product may not reliably provide the SPF 50 protection stated on the label. This is a subpotent product issue, meaning the active ingredients may not be present in sufficient quantities to deliver the advertised level of sun protection.

Consumers who have purchased this product should stop using it and return it to the place of purchase for a refund or contact the recalling firm for further instructions. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product: 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
Manufacturer: Allies Group Inc.
Category: Drug — Sunscreen
Hazard: subpotent-product
mis-labeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

Lots: C13W01A
Exp. 3/27/2027
G23W01A
Exp. 7/24/2027
M04W01
Exp. 12/10/2028.

Distribution

Distributed nationwide across the United States.

Same manufacturer · Allies Group Inc.

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Allies Group Recalls Subpotent SPF 50 Sunscreen Gel Nationwide
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Allies Group Recalls Subpotent SPF 50 Sunscreen Gel
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