SPL v2
SPL
SPL Set ID 24d24776-0f5e-4218-b29f-e8461528a6c3
Route
TOPICAL
Published
Effective Date 2014-04-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (3.5 mg) Octisalate (2 mg)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-03-01

Description

Active Ingredients: Ethylhexyl Methoxycinnamate 7%, Ethylhexyl Salicylate 4%

Purpose

Purpose: UVA/UVB Protection


Medication Information

Purpose

Purpose: UVA/UVB Protection

Description

Active Ingredients: Ethylhexyl Methoxycinnamate 7%, Ethylhexyl Salicylate 4%

Warnings

Warnings:

1. If following symptoms occur, stop use and consult a doctor: red spots, swelling, itcihng, irritation, or symtoms on applied skin under direct sunlight.

2. Do not use on scarred skin, or if you have dermatitis or eczema

3. Keep the cap close on its product

4. Keep away from direct sunlight or heat.

Active Ingredient

Active Ingredients: Ethylhexyl Methoxycinnamate 7%, Ethylhexyl Salicylate 4%

Inactive Ingredient

Inactive Ingredients:

Water, Butylene Glycol, Caprylic/Capric Triglyceride, Phenylbenzimidazole Sulfonic Acid, Disiloxane, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Ceteareth-6 Olivate, Niacinamide, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Tromethamine, Dimethicone, Tocopheryl Acetate, Benzyl Alcohol, Microcrystalline Cellulose, Fragrance, Portulaca Oleracea Extract, Phenoxyethanol, Sodium Benzoate, Disodium EDTA, Potassium Sorbate, Glycerin, Cetearyl Olivate, Sorbitan Olivate, Adenosine, Cellulose Gum, Alpinia Officinarum Root Extract, Lactobacillus/Nelumbo Nucifera Seed Ferment Filtrate, Citrullus Lanatus (Watermelon) Fruit Extract, Terminalia Chebula Fruit Extract, Abies Koreana Leaf Extract, Aloe Barbadensis Leaf Juice

Indications and Usage

Indication and Usage:

Spray onto areas exposed to UV rays from about 20-30cm aways. (Use before or after makeup.)

Dosage and Administration

Dosage and Administration:

2-3 time spry onto the areas that exposed to UV rays, and tap on applied skin for better aborption.

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: UVA/UVB Protection

Warnings (WARNINGS)

Warnings:

1. If following symptoms occur, stop use and consult a doctor: red spots, swelling, itcihng, irritation, or symtoms on applied skin under direct sunlight.

2. Do not use on scarred skin, or if you have dermatitis or eczema

3. Keep the cap close on its product

4. Keep away from direct sunlight or heat.

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredients: Ethylhexyl Methoxycinnamate 7%, Ethylhexyl Salicylate 4%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients:

Water, Butylene Glycol, Caprylic/Capric Triglyceride, Phenylbenzimidazole Sulfonic Acid, Disiloxane, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Ceteareth-6 Olivate, Niacinamide, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Tromethamine, Dimethicone, Tocopheryl Acetate, Benzyl Alcohol, Microcrystalline Cellulose, Fragrance, Portulaca Oleracea Extract, Phenoxyethanol, Sodium Benzoate, Disodium EDTA, Potassium Sorbate, Glycerin, Cetearyl Olivate, Sorbitan Olivate, Adenosine, Cellulose Gum, Alpinia Officinarum Root Extract, Lactobacillus/Nelumbo Nucifera Seed Ferment Filtrate, Citrullus Lanatus (Watermelon) Fruit Extract, Terminalia Chebula Fruit Extract, Abies Koreana Leaf Extract, Aloe Barbadensis Leaf Juice

Indications and Usage (INDICATIONS AND USAGE)

Indication and Usage:

Spray onto areas exposed to UV rays from about 20-30cm aways. (Use before or after makeup.)

Dosage and Administration (DOSAGE AND ADMINISTRATION)

Dosage and Administration:

2-3 time spry onto the areas that exposed to UV rays, and tap on applied skin for better aborption.

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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