SPL v1
SPL
SPL Set ID 06bf6c78-1a9d-43ba-9979-4a1a23d93688
Route
TOPICAL
Published
Effective Date 2015-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (3.75 mg) Octisalate (2.50 mg) Avobenzone (1.50 mg)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-10-01

Description

Active Ingredient: Ethylhexyl Methoxycinnamate 7.50%, Ethylhexyl Salicylate 5.00%, Butyl Methoxydibenzoylmethane 3.00%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

How to use: Apply an appropriate amount to areas exposed to sunlight such as the face, neck, arms, legs, and spread evenly.

Recommended dosage: Spread an appropriate amount over areas exposed to sunlight such as the face, neck, arms, and legs

Warnings

Warnings: 1. If the following side effects occur, immediately discontinue use. Before resuming use, consult a dermatologist as continual use may worsen symptoms. A) If red spots, swelling, itching, irritation, or other discomforts occur after using the product. B) If the above symptoms occur on the applied area after exposure to direct sunlight. 2. Do not use on open wounds or on areas of skin exhibiting signs of eczema or dermatitis. 3. Storage and handling precautions A) Keep product out of reach of infants and children. B) Ensure that lid is closed after use. C) Do not store in places subject to high or cold temperatures or under exposure to direct sunlight. D) Use care to avoid eye contact when using this product.

Active Ingredient

Active Ingredient: Ethylhexyl Methoxycinnamate 7.50%, Ethylhexyl Salicylate 5.00%, Butyl Methoxydibenzoylmethane 3.00%

Inactive Ingredient

Inactive Ingredients: Water, Butylene Glycol, Caprylic/Capric Triglyceride, Phenylbenzimidazole Sulfonic Acid, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Niacinamide, Cetearyl Alcohol, Methyl Methacrylate Crosspolymer, Cyclopentasiloxane, Glyceryl Stearate, Cetearyl Olivate, Glycerin, Sorbitan Olivate, Oryza Sativa (Rice) Bran Extract, Sodium Hydroxide, Cyclohexasiloxane, Nylon-12, Polyacrylate-13, Sorbitan Stearate, Dimethicone, PEG-100 Stearate, Caprylyl Glycol, Polyisobutene, Ethylhexylglycerin, Tocopheryl Acetate, Fragrance, Disodium EDTA, Dextrin, 1,2-Hexanediol, Polysorbate 20, Sorbitan Isostearate, BHT, Citrus Aurantifolia (Lime) Flower Extract, Prunus Persica (Peach) Flower Extract, Propylene Glycol, Pyrus Malus (Apple) Flower Extract, Ananas sativus (pineapple) fruit Extract, Actinidia Chinensis (Kiwi) Fruit Extract, Alchemilla Vulgaris Extract, Arnica Montana Flower Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Adansonia Digitata Seed Extract, Equisetum Arvense Extract, Olea Europaea (Olive) Leaf Extract, Punica Granatum Flower Extract, Prunus Avium (Sweet Cherry) Flower Extract, Citrus Aurantium Dulcis (Orange) Flower Extract, Sophora Japonica Flower Extract, Fructan, Phenoxyethanol

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Warnings (WARNINGS)

Warnings: 1. If the following side effects occur, immediately discontinue use. Before resuming use, consult a dermatologist as continual use may worsen symptoms. A) If red spots, swelling, itching, irritation, or other discomforts occur after using the product. B) If the above symptoms occur on the applied area after exposure to direct sunlight. 2. Do not use on open wounds or on areas of skin exhibiting signs of eczema or dermatitis. 3. Storage and handling precautions A) Keep product out of reach of infants and children. B) Ensure that lid is closed after use. C) Do not store in places subject to high or cold temperatures or under exposure to direct sunlight. D) Use care to avoid eye contact when using this product.

Description (DESCRIPTION)

How to use: Apply an appropriate amount to areas exposed to sunlight such as the face, neck, arms, legs, and spread evenly.

Recommended dosage: Spread an appropriate amount over areas exposed to sunlight such as the face, neck, arms, and legs

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredient: Ethylhexyl Methoxycinnamate 7.50%, Ethylhexyl Salicylate 5.00%, Butyl Methoxydibenzoylmethane 3.00%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients: Water, Butylene Glycol, Caprylic/Capric Triglyceride, Phenylbenzimidazole Sulfonic Acid, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Niacinamide, Cetearyl Alcohol, Methyl Methacrylate Crosspolymer, Cyclopentasiloxane, Glyceryl Stearate, Cetearyl Olivate, Glycerin, Sorbitan Olivate, Oryza Sativa (Rice) Bran Extract, Sodium Hydroxide, Cyclohexasiloxane, Nylon-12, Polyacrylate-13, Sorbitan Stearate, Dimethicone, PEG-100 Stearate, Caprylyl Glycol, Polyisobutene, Ethylhexylglycerin, Tocopheryl Acetate, Fragrance, Disodium EDTA, Dextrin, 1,2-Hexanediol, Polysorbate 20, Sorbitan Isostearate, BHT, Citrus Aurantifolia (Lime) Flower Extract, Prunus Persica (Peach) Flower Extract, Propylene Glycol, Pyrus Malus (Apple) Flower Extract, Ananas sativus (pineapple) fruit Extract, Actinidia Chinensis (Kiwi) Fruit Extract, Alchemilla Vulgaris Extract, Arnica Montana Flower Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Adansonia Digitata Seed Extract, Equisetum Arvense Extract, Olea Europaea (Olive) Leaf Extract, Punica Granatum Flower Extract, Prunus Avium (Sweet Cherry) Flower Extract, Citrus Aurantium Dulcis (Orange) Flower Extract, Sophora Japonica Flower Extract, Fructan, Phenoxyethanol

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


Advanced Ingredient Data


Raw Label Data

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