SPL v1
SPL
SPL Set ID 5019abfb-9f92-4360-ab0d-42a6d766c23f
Route
TOPICAL
Published
Effective Date 2015-03-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (4.50 mg) Zinc Cation (3.15 mg)
Inactive Ingredients
Butylene Glycol Phenyl Trimethicone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-02-01

Description

Active Ingredients: Titanium Dioxide 9.01%, Zinc Oxide 6.30%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Active Ingredients: Titanium Dioxide 9.01%, Zinc Oxide 6.30%

Warnings

Warning: 1. In case of having following symptoms after using this, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In case of getting it into your eyes, you have to wash it immediately.

Active Ingredient

Active Ingredients: Titanium Dioxide 9.01%, Zinc Oxide 6.30%

Inactive Ingredient

Inactive Ingredients: Snail Secretion Filtrate, Butylene Glycol, Phenyl Trimethicone, Dimethicone, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Butylene Glycol Dicaprylate/Dicaprate, Orbignya Oleifera Seed Oil, Cetyl PEG/PPG-10/1 Dimethicone, Arbutin, Magnesium Sulfate, Aluminum Hydroxide, Stearic Acid, Iron Oxides (CI 77492), Water, Caprylyl Glycol, Polyglyceryl-4 Isostearate, Hexyl Laurate, Triethoxycaprylylsilane, Phenoxyethanol, Ethylhexylglycerin, Dimethicone/Vinyl Dimethicone Crosspolymer, Talc, Iron Oxides (CI 77499), Iron Oxides (CI 77491), Tocopheryl Acetate, Sorbitan Isostearate, Rosa Canina Fruit Oil, Calcium Stearate, 1,2-Hexanediol, Glycerin, Imperata Cylindrica Root Extract, Adenosine, Disodium EDTA, Citrus Medica Limonum (Lemon) Peel Oil, Camellia Sinensis Callus Culture Extract, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Oryza Sativa (Rice) Callus Culture Extract, Leontopodium Alpinum Callus Culture Extract, PEG-8, Citrus aurantium dulcis (orange) peel oil, Steareth-20, Citrus Aurantifolia (Lime) Oil, Pinus Sylvestris Leaf Oil, Eucalyptus Globulus Leaf Oil, Centella Asiatica Extract, Carbomer, Aloe Barbadensis Leaf Juice, Usnea Barbata (Lichen) Extract, Zanthoxylum Piperitum Fruit Extract, Xanthan Gum, Pulsatilla Koreana Extract, N-Hydroxysuccinimide, Potassium sorbate, Sodium Hyaluronate, Lecithin, Sodium Benzoate, Acetyl Hexapeptide-8, Palmitoyl Oligopeptide, Chrysin, Palmitoyl Tetrapeptide-7, Chlorhexidine digluconate

Indications & Usage

Indication & Usage: After application of skin care products, apply on face using fingers or sponge.

Dosage & Administration

Dosage & Administration: Take an adequate amount of this product.

Keep Out of Reach of Children

Keep out of reach of Children: Keep out of reach of babies and children

Package Label.principal Display Panel

Image of carton


Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Warnings (WARNINGS)

Warning: 1. In case of having following symptoms after using this, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In case of getting it into your eyes, you have to wash it immediately.

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredients: Titanium Dioxide 9.01%, Zinc Oxide 6.30%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients: Snail Secretion Filtrate, Butylene Glycol, Phenyl Trimethicone, Dimethicone, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Butylene Glycol Dicaprylate/Dicaprate, Orbignya Oleifera Seed Oil, Cetyl PEG/PPG-10/1 Dimethicone, Arbutin, Magnesium Sulfate, Aluminum Hydroxide, Stearic Acid, Iron Oxides (CI 77492), Water, Caprylyl Glycol, Polyglyceryl-4 Isostearate, Hexyl Laurate, Triethoxycaprylylsilane, Phenoxyethanol, Ethylhexylglycerin, Dimethicone/Vinyl Dimethicone Crosspolymer, Talc, Iron Oxides (CI 77499), Iron Oxides (CI 77491), Tocopheryl Acetate, Sorbitan Isostearate, Rosa Canina Fruit Oil, Calcium Stearate, 1,2-Hexanediol, Glycerin, Imperata Cylindrica Root Extract, Adenosine, Disodium EDTA, Citrus Medica Limonum (Lemon) Peel Oil, Camellia Sinensis Callus Culture Extract, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Oryza Sativa (Rice) Callus Culture Extract, Leontopodium Alpinum Callus Culture Extract, PEG-8, Citrus aurantium dulcis (orange) peel oil, Steareth-20, Citrus Aurantifolia (Lime) Oil, Pinus Sylvestris Leaf Oil, Eucalyptus Globulus Leaf Oil, Centella Asiatica Extract, Carbomer, Aloe Barbadensis Leaf Juice, Usnea Barbata (Lichen) Extract, Zanthoxylum Piperitum Fruit Extract, Xanthan Gum, Pulsatilla Koreana Extract, N-Hydroxysuccinimide, Potassium sorbate, Sodium Hyaluronate, Lecithin, Sodium Benzoate, Acetyl Hexapeptide-8, Palmitoyl Oligopeptide, Chrysin, Palmitoyl Tetrapeptide-7, Chlorhexidine digluconate

Indications & Usage (INDICATIONS & USAGE)

Indication & Usage: After application of skin care products, apply on face using fingers or sponge.

Dosage & Administration (DOSAGE & ADMINISTRATION)

Dosage & Administration: Take an adequate amount of this product.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

Keep out of reach of Children: Keep out of reach of babies and children

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

Image of carton


Advanced Ingredient Data


Raw Label Data

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