FDA recall D-0824-2026

Allies Group Inc. · Class II · drug

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

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

Key facts

Status
Ongoing
Initiation date
2026-08-14
Report date
2026-09-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Wilmington, DE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0824-2026