SPL v1
SPL
SPL Set ID 80e4f4fd-16d2-4c9f-bf4b-e19dce87d9e5
Route
TOPICAL
Published
Effective Date 2017-03-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (2.75 g) Octisalate (2.5 g) Ensulizole (2.0 g) Avobenzone (1.5 g)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-03-02

Description

Active ingredients: Ethylhexyl Methoxycinnamate 5.50%, Ethylhexyl Salicylate 5.00%, Phenylbenzimidazole Sulfonic Acid 4.00%, Butyl Methoxydibenzoylmethane 3.00%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Indications & Usage: Helps prevent and relieve chapped or cracked skin.

Dosage & Administration: Take a proper amount of product, and spread it evenly over the entire face.

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 ingredients: Ethylhexyl Methoxycinnamate 5.50%, Ethylhexyl Salicylate 5.00%, Phenylbenzimidazole Sulfonic Acid 4.00%, Butyl Methoxydibenzoylmethane 3.00%

Inactive Ingredient

Inactive ingredients: Water, Butylene Glycol,Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, C12-15 Alkyl Benzoate,Arbutin,Cetearyl Alcohol,Glycerin,Glyceryl Stearate,Cetearyl Olivate,Polysorbate 60, Sorbitan Olivate,PEG-100 Stearate,Sorbitan Stearate,Sodium Hydroxide,Dimethicone, Methyl Methacrylate Crosspolymer, VP/Hexadecene Copolymer, Polyacrylate-13, Caprylyl Glycol, Ethylhexylglycerin, Fragrance, Polyisobutene, Ceramide NP, Human Stem Cell Conditioned Media, Disodium EDTA, 1,2-Hexanediol, Tocopheryl Acetate, Phospholipids, Adenosine, Polysorbate 20, BHT, Phytosphingosine, Sorbitan Isostearate, CI 17200

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)

Indications & Usage: Helps prevent and relieve chapped or cracked skin.

Dosage & Administration: Take a proper amount of product, and spread it evenly over the entire face.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Ethylhexyl Methoxycinnamate 5.50%, Ethylhexyl Salicylate 5.00%, Phenylbenzimidazole Sulfonic Acid 4.00%, Butyl Methoxydibenzoylmethane 3.00%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients: Water, Butylene Glycol,Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, C12-15 Alkyl Benzoate,Arbutin,Cetearyl Alcohol,Glycerin,Glyceryl Stearate,Cetearyl Olivate,Polysorbate 60, Sorbitan Olivate,PEG-100 Stearate,Sorbitan Stearate,Sodium Hydroxide,Dimethicone, Methyl Methacrylate Crosspolymer, VP/Hexadecene Copolymer, Polyacrylate-13, Caprylyl Glycol, Ethylhexylglycerin, Fragrance, Polyisobutene, Ceramide NP, Human Stem Cell Conditioned Media, Disodium EDTA, 1,2-Hexanediol, Tocopheryl Acetate, Phospholipids, Adenosine, Polysorbate 20, BHT, Phytosphingosine, Sorbitan Isostearate, CI 17200

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


Advanced Ingredient Data


Raw Label Data

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