FDA Label for Protectif Untinted
View Indications, Usage & Precautions
Protectif Untinted Product Label
The following document was submitted to the FDA by the labeler of this product Derma Research Group Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredients: Zinc Oxide 8.6%, Titanium Dioxide 6.5%
Otc - Purpose
Purpose: Sun Protectant
Indications & Usage
Uses: Broad spectrum (Sun Protection Factor 50 /SPF 50).
Warnings
Warning: For external use only.
Otc - Do Not Use
Do not use on damaged or broken skin.
Otc - When Using
When using this product avoid contact with the eyes. If contact occurs, rinse thoroughly with water.
Otc - Stop Use
Discontinue use if rash or irritation develops or lasts. If irritation persists, consult a doctor.
Otc - Keep Out Of Reach Of Children
Keep out of reach of Children -if swallowed get medical help or contact Poison Control Center right away.
Dosage & Administration
Directions: Adults and Children over 6 months of age: Apply generously and evenly 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 take other sun protection measures including limiting time in the sun, especially from 10 a.m. - 2 p.m., and wearing long-sleeve shirts, pants, hats and sunglasses
Other Safety Information
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 take other sun protection measures including limiting time in the sun, especially from 10 a.m. - 2 p.m., and wearing long-sleeve shirts, pants, hats and sunglasses
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-1011 Dimethicone, Hexyl Laurate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, 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 Deca hydrate, Hydroxytyrosol, Polygonum Aviculare Extract, Sodium Benzoate, Potassium Sorbate, Alcohol, Lecithin, Ectoin, Cyclotetra peptide-24 Aminocyclohexane Carboxylate, Carbomer, Polysorbate 20, Palmitoyl Tripeptide-1, Palmitoyl Tetra peptide-7, Vitis Vinifera (Grape) Fruit Cell Extract, Isomalt, Camellia Sinensis Leaf Extract, Coffee Arabica (Coffee) Seed Extract, Citric Acid, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol
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