Active Ingredients:
Zinc Oxide 20%
Tizo Ultra Zinc Spf 40 (tinted) Cream
FDA Label NDC 58892-319
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 Tizo Ultra Zinc Spf 40 (tinted) (NDC 58892-319). 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 active ingredients:, purpose:, directions:, warnings:, warnings and directions:, inactive ingredient, warning:, 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
Purpose:
Sunscreen
Directions:
Apply liberally 15 minutes before sun exposure.
Warnings:
For external use only. Keep out of the reach of children.
Warnings And Directions:
For external use only. Keep out of the reach of children. Apply liberally 15 minutes before suns exposure.
Inactive Ingredient
Bismuth Oxychloride, C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Hydrogen Dimethicone, Iron Oxides, Mica, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water
Warning:
Keep out of the reach of children.
* Please review the disclaimer below.
