SPL v1
SPL
SPL Set ID 54e9f1b6-f691-4424-b1a4-6d058f736903
Route
TOPICAL
Published
Effective Date 2016-06-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (2.75 g) Octisalate (2.50 g) Ensulizole (2.00 g) Avobenzone (1.50 g)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-05-01

Description

Active ingredient: Ethylhexyl Methoxycinnamate 5.5%, Ethylhexyl Salicylate 5.0%, Phenylbenzimidazole Sulfonic Acid 4.0%, Butyl Methoxydibenzoylmethane 3.0%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Use: Helps prevent and relieve chapped or cracked skin.

Directions: - Clean the skin thoroughly before using - Apply in daily skin care routine

Warnings

Warnings: For external use only. When using this product do not get into eyes. Stop use and ask a doctor if rash occurs. Do not use on - deep puncture wounds - animal bites - serious burns Keep out of reach of children.

Active Ingredient

Active ingredient: Ethylhexyl Methoxycinnamate 5.5%, Ethylhexyl Salicylate 5.0%, Phenylbenzimidazole Sulfonic Acid 4.0%, Butyl Methoxydibenzoylmethane 3.0%

Inactive Ingredient

Inactive Ingredient: Water, Snail Secretion Filtrate, Butylene Glycol, Methyl Methacrylate Crosspolymer, C12-15 Alkyl Benzoate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Polymethylsilsesquioxane, Arbutin, Glyceryl Stearate, Cetearyl Olivate, Sorbitan Olivate, Cetearyl Alcohol, Sodium Hydroxide, Dimethicone, PEG-100 Stearate, Polyacrylate-13, Caprylyl Glycol, Panthenol, Polyisobutene, Ethylhexylglycerin, Tocopheryl Acetate, Citrus Limon (Lemon) Peel Oil, Sorbitan Stearate, Chamaecyparis Obtusa Water, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, BHT, 1,2-Hexanediol, Sorbitan Isostearate, Polysorbate 20, Glycerin, Adenosine, Imperata Cylindrica Root Extract, Citrus aurantium dulcis (orange) peel oil, Disodium EDTA, Opuntia Ficus-Indica Extract, Citrus Aurantifolia (Lime) Oil, Propanediol, Pinus Sylvestris Leaf Oil, PEG-8, Eucalyptus Globulus Leaf Oil, Phenoxyethanol, Centella Asiatica Extract, Carbomer, Carica papaya (papaya) fruit Extract, Aloe Barbadensis Leaf Juice, Beta-Glucan, Potassium sorbate, Sodium Benzoate

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Warnings (WARNINGS)

Warnings: For external use only. When using this product do not get into eyes. Stop use and ask a doctor if rash occurs. Do not use on - deep puncture wounds - animal bites - serious burns Keep out of reach of children.

Description (DESCRIPTION)

Use: Helps prevent and relieve chapped or cracked skin.

Directions: - Clean the skin thoroughly before using - Apply in daily skin care routine

Active Ingredient (ACTIVE INGREDIENT)

Active ingredient: Ethylhexyl Methoxycinnamate 5.5%, Ethylhexyl Salicylate 5.0%, Phenylbenzimidazole Sulfonic Acid 4.0%, Butyl Methoxydibenzoylmethane 3.0%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredient: Water, Snail Secretion Filtrate, Butylene Glycol, Methyl Methacrylate Crosspolymer, C12-15 Alkyl Benzoate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Polymethylsilsesquioxane, Arbutin, Glyceryl Stearate, Cetearyl Olivate, Sorbitan Olivate, Cetearyl Alcohol, Sodium Hydroxide, Dimethicone, PEG-100 Stearate, Polyacrylate-13, Caprylyl Glycol, Panthenol, Polyisobutene, Ethylhexylglycerin, Tocopheryl Acetate, Citrus Limon (Lemon) Peel Oil, Sorbitan Stearate, Chamaecyparis Obtusa Water, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, BHT, 1,2-Hexanediol, Sorbitan Isostearate, Polysorbate 20, Glycerin, Adenosine, Imperata Cylindrica Root Extract, Citrus aurantium dulcis (orange) peel oil, Disodium EDTA, Opuntia Ficus-Indica Extract, Citrus Aurantifolia (Lime) Oil, Propanediol, Pinus Sylvestris Leaf Oil, PEG-8, Eucalyptus Globulus Leaf Oil, Phenoxyethanol, Centella Asiatica Extract, Carbomer, Carica papaya (papaya) fruit Extract, Aloe Barbadensis Leaf Juice, Beta-Glucan, Potassium sorbate, Sodium Benzoate

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

KEEP OUT OF REACH OF CHILDREN

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


Advanced Ingredient Data


Raw Label Data

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