SPL v1
SPL
SPL Set ID 58a3462e-5ef3-4f93-b7e9-d58d000fe414
Route
TOPICAL
Published
Effective Date 2017-10-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (1.31 g) Octinoxate (0.67 g) Octisalate (0.40 g)
Inactive Ingredients
Water Diisostearyl Malate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-10-01

Description

Active ingredients: Titanium Dioxide 13.19%, Ethylhexyl Methoxycinnamate 6.70%, Ethylhexyl Salicylate 4.00%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Uses:

step1. Apply conceal balm after basic skin care to cover up dark spots and imperfections.

step2. Then apply cushion all over for a fresh-faced finish.

Directions: Dual cover cushion in light fitting texture with micro-jewel extract provides full coverage and luminous radiance

Warnings

Warnings: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Keep this product out of the direct rays of the sun. Keep Out of Reach of Children.

Active Ingredient

Active ingredients: Titanium Dioxide 13.19%, Ethylhexyl Methoxycinnamate 6.70%, Ethylhexyl Salicylate 4.00%

Inactive Ingredient

Inactive ingredients: Water, Diisostearyl Malate, Cyclopentasiloxane, Glycerin, Phenyl Trimethicone , Cyclohexasiloxane, Butylene Glycol, Trimethylsiloxysilicate, LaurylDimethiconePEG-9 Polydimethylsiloxyethyl, Niacinamide, Pentylene, Glycol, Methyl Methacrylate Crosspolymer, Polypropylsilsesquioxane, Iron Oxides (CI 77492), Magnesium Sulfate, Phenoxyethanol, Cetyl PEG/PPG-10/1 Dimethicone, Stearic Acid, Alumina, Aluminum Hydroxide, Dimethicone, Triethoxycaprylylsilane, Iron Oxides (CI 77491), Fragrance(Parfum), Dimethicone Crosspolymer, Disteardimonium Hectorite, Ethylhexylglycerin, Iron Oxides (CI 77499), Adenosine, Hydrogenated Castor Oil Isostearate, Disodium EDTA, Silica, Silica Dimethyl Silylate, CrosspolymerVinyl Dimethicone/Methicone Silsesquioxane, HDI/Trimethylol Hexyllactone, Crosspolymer, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Diamond powder, Hydrolyzed Silk, Oryza Sativa (Rice) Bran Oil, Salix Alba (Willow) Bark Extract, Tocopheryl Acetate, Polymethylsilsesquioxane, Pearl Extract, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Xylitylglucoside, Anhydroxylitol, Xylitol, Lupinus Albus Seed Extract, Fucus Vesiculosus Extract, Vanilla Tahitensis Fruit Extract, Ascophyllum Nodosum Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Pelvetia Canaliculata Extract, Platinum Powder

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Warnings (WARNINGS)

Warnings: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Keep this product out of the direct rays of the sun. Keep Out of Reach of Children.

Description (DESCRIPTION)

Uses:

step1. Apply conceal balm after basic skin care to cover up dark spots and imperfections.

step2. Then apply cushion all over for a fresh-faced finish.

Directions: Dual cover cushion in light fitting texture with micro-jewel extract provides full coverage and luminous radiance

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Titanium Dioxide 13.19%, Ethylhexyl Methoxycinnamate 6.70%, Ethylhexyl Salicylate 4.00%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients: Water, Diisostearyl Malate, Cyclopentasiloxane, Glycerin, Phenyl Trimethicone , Cyclohexasiloxane, Butylene Glycol, Trimethylsiloxysilicate, LaurylDimethiconePEG-9 Polydimethylsiloxyethyl, Niacinamide, Pentylene, Glycol, Methyl Methacrylate Crosspolymer, Polypropylsilsesquioxane, Iron Oxides (CI 77492), Magnesium Sulfate, Phenoxyethanol, Cetyl PEG/PPG-10/1 Dimethicone, Stearic Acid, Alumina, Aluminum Hydroxide, Dimethicone, Triethoxycaprylylsilane, Iron Oxides (CI 77491), Fragrance(Parfum), Dimethicone Crosspolymer, Disteardimonium Hectorite, Ethylhexylglycerin, Iron Oxides (CI 77499), Adenosine, Hydrogenated Castor Oil Isostearate, Disodium EDTA, Silica, Silica Dimethyl Silylate, CrosspolymerVinyl Dimethicone/Methicone Silsesquioxane, HDI/Trimethylol Hexyllactone, Crosspolymer, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Diamond powder, Hydrolyzed Silk, Oryza Sativa (Rice) Bran Oil, Salix Alba (Willow) Bark Extract, Tocopheryl Acetate, Polymethylsilsesquioxane, Pearl Extract, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Xylitylglucoside, Anhydroxylitol, Xylitol, Lupinus Albus Seed Extract, Fucus Vesiculosus Extract, Vanilla Tahitensis Fruit Extract, Ascophyllum Nodosum Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Pelvetia Canaliculata Extract, Platinum Powder

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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