SPL v1
SPL
SPL Set ID ae28ea61-b1f4-451c-b439-551f05bda0a7
Route
TOPICAL
Published
Effective Date 2015-06-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (3.5 mg) Octocrylene (2.5 mg) Octisalate (2.25 mg) Avobenzone (2.0 mg)
Inactive Ingredients
Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-05-01

Description

Active Ingredient: Ethylhexyl Methoxycinnamate 7.0%, Octocrylene 5.0%, Ethylhexyl Salicylate 4.5%, Butyl Methoxydibenzoylmethane 4.0%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Directions & Usage: Apply a suitable amount to and spread evenly on your skin that would be exposed to sun after all basic skin care.

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

Warnings

Warnings: 1. If any of the following symptoms appear on the area where the product was applied, stop using the product immediately and consult a specialist. A. Redness, swelling, itchiness, irritation or other abnormal symptoms B. Symptoms above appear after exposure to direct sunlight 2. DO NOT use the product on an area with wound, eczema, or dermatitis 3. Storage and handling. A. Make sure to close the lid after use B. Keep away from children and babies C. DO NOT store in a place with high or low temperature and direct sunlight 4. Use the product once a week due to high content of Vitamin C. If your skin is not irritated or sensitive either, you can apply it twice or three times a week.

Active Ingredient

Active Ingredient: Ethylhexyl Methoxycinnamate 7.0%, Octocrylene 5.0%, Ethylhexyl Salicylate 4.5%, Butyl Methoxydibenzoylmethane 4.0%

Inactive Ingredient

Inactive Ingredients: Chamaecyparis Obtusa Water, Butylene Glycol, Alcohol Denat., Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Methyl Methacrylate Crosspolymer, Dipropylene Glycol, Polysorbate 60, Dimethicone, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylyl Glycol, Cyclopentasiloxane, Methoxy PEG/PPG-25/4 Dimethicone, Bis-PEG/PPG-20/5 PEG/PPG-20/5 Dimethicone, Isohexadecane, Phenoxyethanol, Ethylhexylglycerin, Fragrance, Polysorbate 80, Cyclohexasiloxane, Caprylic/Capric Triglyceride, 1,2-Hexanediol, BHT, Potassium Hydroxide, Disodium EDTA, Water, Rosa Canina Fruit Oil, Sea Water, Melaleuca Alternifolia (Tea Tree) Leaf Water, Propylene Glycol, Aspalathus Linearis Leaf Extract, Hamamelis Virginiana (Witch Hazel) Water, Caulerpa Lentillifera Extract, Glycerin, Alcohol, Pentylene Glycol, Hippophae Rhamnoides Fruit Extract, Camellia Sinensis Leaf Extract, Sodium Hyaluronate, Hydrolyzed Collagen

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Warnings (WARNINGS)

Warnings: 1. If any of the following symptoms appear on the area where the product was applied, stop using the product immediately and consult a specialist. A. Redness, swelling, itchiness, irritation or other abnormal symptoms B. Symptoms above appear after exposure to direct sunlight 2. DO NOT use the product on an area with wound, eczema, or dermatitis 3. Storage and handling. A. Make sure to close the lid after use B. Keep away from children and babies C. DO NOT store in a place with high or low temperature and direct sunlight 4. Use the product once a week due to high content of Vitamin C. If your skin is not irritated or sensitive either, you can apply it twice or three times a week.

Description (DESCRIPTION)

Directions & Usage: Apply a suitable amount to and spread evenly on your skin that would be exposed to sun after all basic skin care.

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

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredient: Ethylhexyl Methoxycinnamate 7.0%, Octocrylene 5.0%, Ethylhexyl Salicylate 4.5%, Butyl Methoxydibenzoylmethane 4.0%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients: Chamaecyparis Obtusa Water, Butylene Glycol, Alcohol Denat., Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Methyl Methacrylate Crosspolymer, Dipropylene Glycol, Polysorbate 60, Dimethicone, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylyl Glycol, Cyclopentasiloxane, Methoxy PEG/PPG-25/4 Dimethicone, Bis-PEG/PPG-20/5 PEG/PPG-20/5 Dimethicone, Isohexadecane, Phenoxyethanol, Ethylhexylglycerin, Fragrance, Polysorbate 80, Cyclohexasiloxane, Caprylic/Capric Triglyceride, 1,2-Hexanediol, BHT, Potassium Hydroxide, Disodium EDTA, Water, Rosa Canina Fruit Oil, Sea Water, Melaleuca Alternifolia (Tea Tree) Leaf Water, Propylene Glycol, Aspalathus Linearis Leaf Extract, Hamamelis Virginiana (Witch Hazel) Water, Caulerpa Lentillifera Extract, Glycerin, Alcohol, Pentylene Glycol, Hippophae Rhamnoides Fruit Extract, Camellia Sinensis Leaf Extract, Sodium Hyaluronate, Hydrolyzed Collagen

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


Advanced Ingredient Data


Raw Label Data

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