Otc - Active Ingredient
Titanium Dioxide 8%
Zinc Oxide 3.8%
Tizo3 Cream
FDA Label NDC 58892-326
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fallien Cosmeceuticals Ltd. for the product Tizo3 (NDC 58892-326). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Indications & Usage
Helps prevent sunburn.
Warnings
For external use only.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
Apply liberally 15 minutes before sun exposure.
Inactive Ingredient
Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (CI 77491), Lauryl PEG/PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate
Package Label.Principal Display Panel
Package Label (Tizo3 5g)
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