SPL v1
SPL
SPL Set ID 883a368f-b56f-44d9-a625-62574ab95bf0
Route
TOPICAL
Published
Effective Date 2014-06-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7.5 mg) Titanium Dioxide (4.25 mg) Octisalate (2 mg)
Inactive Ingredients
Water Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-05-01

Description

Active Ingredients: Ethylhexyl Methoxycinnamate 7.5%, Titanium Dioxide 4.25%, Ethylhexyl Salicylate 2%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Active Ingredients: Ethylhexyl Methoxycinnamate 7.5%, Titanium Dioxide 4.25%, Ethylhexyl Salicylate 2%

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: Ethylhexyl Methoxycinnamate 7.5%, Titanium Dioxide 4.25%, Ethylhexyl Salicylate 2%

Inactive Ingredient

Inactive Ingredients:

Water, Glycerin, Ethylhexyl Palmitate, Cyclopentasiloxane, 4-Methylbenzylidene Camphor, Butyl Methoxydibenzoylmethane, Octocrylene, Cyclohexasiloxane, Silica, Aloe Barbadensis Leaf Juice, Lavandula Angustifolia (Lavender) Water, Anthemis Nobilis Flower Water, Prunus Mume Fruit Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Codium Tomentosum Extract, Enteromorpha Compressa Extract, Macrocystis Pyrifera (Kelp) Extract, Ecklonia Cava Extract, Gelidium Cartilagineum Extract, Laminaria Japonica Extract, Nymphaea Alba Flower Extract, Chamaecyparis Obtusa Leaf Extract, Viscum Album (Mistletoe) Fruit Extract, Sansevieria Trifasciata Leaf Extract, Portulaca Oleracea Extract, Glyceryl Stearate, PEG-100 Stearate, Triceteareth-4 Phosphate, Glycol Stearate, Sorbitan Sesquioleate, Potassium Cetyl Phosphate, PEG-2 Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glyceryl Caprylate, Bis-Diglyceryl Polyacyladipate-2, Tromethamine, Caprylyl Glycol, Dimethicone, Butylene Glycol, Polydecene, Dipropylene Glycol, Sodium Palmitoyl Proline, Squalane, Coco-Glucoside, Sorbic Acid, Ethylhexylglycerin, Acetyl Tetrapeptide-15, Cetearyl Alcohol, Xanthan Gum, Disodium EDTA, Phenoxyethanol, Benzyl Alcohol, Potassium Sorbate, Dehydroacetic Acid, Sodium Benzoate, Fragrance(Parfum)

Indications and Usage

Indications and usage:

Take one pearl size amount on cheeks, forehead and chin and spread following the skin texture.

Dosage and Administration

Dosage and administration:

Take an adequate amount of this product.

Keep Out of Reach of Children

Keep out of reach of babies and children

Package Label.principal Display Panel


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: Ethylhexyl Methoxycinnamate 7.5%, Titanium Dioxide 4.25%, Ethylhexyl Salicylate 2%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients:

Water, Glycerin, Ethylhexyl Palmitate, Cyclopentasiloxane, 4-Methylbenzylidene Camphor, Butyl Methoxydibenzoylmethane, Octocrylene, Cyclohexasiloxane, Silica, Aloe Barbadensis Leaf Juice, Lavandula Angustifolia (Lavender) Water, Anthemis Nobilis Flower Water, Prunus Mume Fruit Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Codium Tomentosum Extract, Enteromorpha Compressa Extract, Macrocystis Pyrifera (Kelp) Extract, Ecklonia Cava Extract, Gelidium Cartilagineum Extract, Laminaria Japonica Extract, Nymphaea Alba Flower Extract, Chamaecyparis Obtusa Leaf Extract, Viscum Album (Mistletoe) Fruit Extract, Sansevieria Trifasciata Leaf Extract, Portulaca Oleracea Extract, Glyceryl Stearate, PEG-100 Stearate, Triceteareth-4 Phosphate, Glycol Stearate, Sorbitan Sesquioleate, Potassium Cetyl Phosphate, PEG-2 Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glyceryl Caprylate, Bis-Diglyceryl Polyacyladipate-2, Tromethamine, Caprylyl Glycol, Dimethicone, Butylene Glycol, Polydecene, Dipropylene Glycol, Sodium Palmitoyl Proline, Squalane, Coco-Glucoside, Sorbic Acid, Ethylhexylglycerin, Acetyl Tetrapeptide-15, Cetearyl Alcohol, Xanthan Gum, Disodium EDTA, Phenoxyethanol, Benzyl Alcohol, Potassium Sorbate, Dehydroacetic Acid, Sodium Benzoate, Fragrance(Parfum)

Indications and Usage (INDICATIONS AND USAGE)

Indications and usage:

Take one pearl size amount on cheeks, forehead and chin and spread following the skin texture.

Dosage and Administration (DOSAGE AND ADMINISTRATION)

Dosage and 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 (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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