Matte Universal Tinted Moisturizer Spf46 Cream
FDA Label NDC 83286-015
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Drmtlgy, Llc for the product Matte Universal Tinted Moisturizer Spf46 (NDC 83286-015). 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 drug facts, active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, precautions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Zinc Oxide 12%
Octinoxate 7.5%
Purpose
Sunscreen
Uses
Helps prevent sunburn • If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.
Warnings
For external use only.
When using this product • keep out of eyes. Rinse with water to remove. Stop use and ask physician if rash occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
• Apply to face and neck, avoiding the eye area. Wait at least 30 minutes before sun exposure, or as directed by a physician. Reapply at least every 2 hours.
Precautions
• Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum value of SPF 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m.-2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months of age: Ask a physician.
Inactive Ingredients
Water/Aqua/Eau, Cyclopentasiloxane, Niacinamide, Oleth-3 Phosphate, Diphenyl Dimethicone/Vinyl Diphenyl Dimethicone/Silsesquioxane Crosspolymer, Octyldodecyl Neopentanoate, Saccharomyces Ferment, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glycerin, Knotweed (Polygonum Aviculare) Extract, Sodium Hyaluronate, Tocopheryl Acetate, Ethylhexylglycerin, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, PEG-7 Trimethylolpropane Coconut Ether, Lauroyl Lysine, Polyisobutene, Triethoxycaprylylsilane, Disodium EDTA, Iron Oxide (CI 77492), Iron Oxide (CI 77491), Iron Oxide (CI 77499), Phenoxyethanol
Packaging
Matte Universal Tinted Spf46 (83286015 1)
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