SPL v1
SPL
SPL Set ID 9a824803-cd98-4b66-bb3e-eb406103ae75
Route
TOPICAL
Published
Effective Date 2014-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (3.5 mg) Zinc Cation (1.5 mg) Titanium Dioxide
Inactive Ingredients
Water Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-01-02

Description

Active Ingredients: Ethylhexyl Methoxycinnamate 7%, Zinc Oxide 3%, Titanium Dioxide 3%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Active Ingredients: Ethylhexyl Methoxycinnamate 7%, Zinc Oxide 3%, Titanium Dioxide 3%

Warnings

Warnings:

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.

- In case of haviong problems such as red rash, swollenness, itching, stimulation during usage.

- 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%, Zinc Oxide 3%, Titanium Dioxide 3%

Inactive Ingredient

Inactive Ingredients:

Water, Cyclopentasiloxane, Cyclomethicone, Propylene Glycol, Glycerin, Dimethicone, Isononyl Isononanoate, 4-Methylbenzylidene Camphor, PEG-10 Dimethicone, Polymethyl Methacrylate, 1,2-Hexanediol, Triethanolamine, Sorbitan Sesquioleate, Magnesium Sulfate,

Disteardimonium Hectorite, Stearic Acid, Aluminum Hydroxide, Betaine, Phenoxyethanol, Dimethicone/Vinyl Dimethicone Crosspolymer, Allantoin, Saccharomyces/Viscum Album (Mistletoe) Ferment Extract, Lactobacillus/Soybean Ferment Extract, Saccharomyces/Imperata Cylindrica Root Ferment Extract, Aloe Barbadensis Leaf Juice Powder, Dipotassium Glycyrrhizate, Butylene Glycol, Larix Sibirica Wood Extract, Chrysanthellum Indicum Extract, Rheum Palmatum Root/Stalk Extract, Asarum Sieboldi Root Extract, Quercus Mongolia Leaf Extract , Persicaria Hydropiper Extract, Illicium Verum (Anise) Fruit Extract, Corydalis Turtschaninovii Root Extract, Coptis Japonica Root Extract, Machilus Thunbergii Bark Extract, Sarcodon Aspratus Extract, Lepidium Meyenii Root Extract, Ethylhexylglycerin, Portulaca Oleracea Extract, Fomes Officinalis (Mushroom) Extract, PEG-40 Hydrogenated Castor Oil, Sodium Hyaluronate, Polyglutamic Acid

Indications and Usage

Indications and usage: After basic skin care, apply adequate amount following the skin texture and gently tap to enhance absorption.

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


Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Warnings (WARNINGS)

Warnings:

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.

- In case of haviong problems such as red rash, swollenness, itching, stimulation during usage.

- 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%, Zinc Oxide 3%, Titanium Dioxide 3%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients:

Water, Cyclopentasiloxane, Cyclomethicone, Propylene Glycol, Glycerin, Dimethicone, Isononyl Isononanoate, 4-Methylbenzylidene Camphor, PEG-10 Dimethicone, Polymethyl Methacrylate, 1,2-Hexanediol, Triethanolamine, Sorbitan Sesquioleate, Magnesium Sulfate,

Disteardimonium Hectorite, Stearic Acid, Aluminum Hydroxide, Betaine, Phenoxyethanol, Dimethicone/Vinyl Dimethicone Crosspolymer, Allantoin, Saccharomyces/Viscum Album (Mistletoe) Ferment Extract, Lactobacillus/Soybean Ferment Extract, Saccharomyces/Imperata Cylindrica Root Ferment Extract, Aloe Barbadensis Leaf Juice Powder, Dipotassium Glycyrrhizate, Butylene Glycol, Larix Sibirica Wood Extract, Chrysanthellum Indicum Extract, Rheum Palmatum Root/Stalk Extract, Asarum Sieboldi Root Extract, Quercus Mongolia Leaf Extract , Persicaria Hydropiper Extract, Illicium Verum (Anise) Fruit Extract, Corydalis Turtschaninovii Root Extract, Coptis Japonica Root Extract, Machilus Thunbergii Bark Extract, Sarcodon Aspratus Extract, Lepidium Meyenii Root Extract, Ethylhexylglycerin, Portulaca Oleracea Extract, Fomes Officinalis (Mushroom) Extract, PEG-40 Hydrogenated Castor Oil, Sodium Hyaluronate, Polyglutamic Acid

Indications and Usage (INDICATIONS AND USAGE)

Indications and usage: After basic skin care, apply adequate amount following the skin texture and gently tap to enhance absorption.

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 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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