Otc - Active Ingredient
Active Ingredients
Zinc Oxide 8.6 %
Titanium Dioxide 6.5 %
Protectif Fair Tint
FDA Label NDC 82038-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Derma Research Group Inc. for the product Protectif Fair Tint (NDC 82038-003). 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 - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Sun Protectant
Indications & Usage
Uses
Helps Prevent sunburn
Warnings
Warning
For external use only
Otc - Do Not Use
Do not use
Do not use on damaged or broken skin.
Otc - When Using
When using
When using this product, avoid contect with eyes.If contect occurs, rinse throughly with water
Otc - Stop Use
stop use
Discontinue use if rash or irritation develops or lasts. If irritation persists,consultant a doctor
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
If swallowed get medical help or contect poison control center right away.
Dosage & Administration
Directions: Apply 15 minutes before sun exposure. Reapply at least every 2 hours. Sun Protection Measures: 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 SPF value of 15 or higher and other sun protection measures including limit time in the sun, especially from 10 a.m. - 2 p.m., wear long-sleeve shirts, pants, hats and sunglasses.
Other Safety Information
NA
Inactive Ingredient
Inactive Ingredients:
Water (Aqua), Cyclopentasiloxane,C12-15 Alkyl Benzoate,Dimethicone,Cyclotetrasiloxane,Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Polysilicone-31,Glycerin,Aluminum Hydroxide,Stearic Acid,Dimethicone/PEG-10/15 Crosspolymer,
Pyrus Malus (Apple) Fruit Extract,Sodium Chloride,Dipropylene Glycol,Sodium Citrate,Tocopherol,Dimethicone/Polyglycerin-3 Crosspolymer,Dimethicone / Vinyl Dimethicone Crosspolymer,Tocopheryl Acetate,PEG/PPG-18/18 Dimethicone,
Polyglyceryl-4 Isostearate,Cetyl PEG/PPG-10/1 Dimethicone,Hexyl Laurate,Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinna mate, Cetearyl Olivate,Sorbitan Olivate, Benzoic Acid,Ethylhexyl Palmitate,Silica Dimethyl Silylate, Butylene Glycol,
Pentylene Glycol,Sodium Hyaluronate, Cyclohexasiloxane,PEG-8, Ascorbyl Palmitate, Ascorbic Acid,Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone,Sodium Ferrocyanide Decahydrate,Hydroxytyrosol, Polygonum Aviculare Extract,
Sodium Benzoate, Potassium Sorbate,Alcohol,Lecithin,Ectoin,Cyclotetrapeptide-24 Aminocyclohexane Carboxylate,Carbomer,
Polysorbate 20,Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7,Vitis Vinifera (Grape) Fruit Cell Extract, Isomalt,
Camellia Sinensis Leaf Extract,Coffea Arabica (Coffee) Seed Extract, Citric Acid,Phenoxyethanol,Caprylyl Glycol,Ethylhexylglycerin,
Hexylene Glycol,Triethoxycaprylylsilane, Iron Oxides (CI 77491, CI 77492, CI 77499)
Package Label.Principal Display Panel
Protectif Fair Tint (Protectiffairtint)
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