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Life sciences · Safety recall
U.S. Food and Drug Administration · September 9, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Safety recall.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
This record has not been graded across any dimension yet. Treat the label above as provisional and read the source.
What is missing. This record has no bottom line, key findings, reported figures, evidence dimensions. That is a gap in the analysis, not a judgement about the study.
FDA enforcement report D-0823-2026. This is a regulatory safety action, not a clinical study. Classification: Class II. Status: Ongoing. Recalling firm: Allies Group Inc.. Initiated as: Voluntary: Firm initiated. 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 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