SPL v1
SPL
SPL Set ID 6c2e804c-ea39-4771-8ff6-c6ff93234794
Route
TOPICAL
Published
Effective Date 2015-07-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (3.4 mg) Zinc Cation (2.5 mg) Octisalate (2.25 mg) Titanium Dioxide (2.0 mg)
Inactive Ingredients
Water Dipropylene Glycol

Identifiers & Packaging

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

Description

Active Ingredient: ETHYLHEXYL METHOXYCINNAMATE 6.80%, ZINC OXIDE 5.00%, ETHYLHEXYL SALICYLATE 4.50%, TITANIUM DIOXIDE 4.00%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Indications & Usage: Apply a desired amount evenly over entire face.

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

Warnings

Warnings: 1. In case of having following symptoms after using this, you’re advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In case of getting it into your eyes, you have to wash it immediately.

Keep out of reach of children: Keep out of reach of babies and children

Active Ingredient

Active Ingredient: ETHYLHEXYL METHOXYCINNAMATE 6.80%, ZINC OXIDE 5.00%, ETHYLHEXYL SALICYLATE 4.50%, TITANIUM DIOXIDE 4.00%

Inactive Ingredient

Inactive Ingredients: Water, Cyclopentasiloxane, Dipropylene Glycol, Peg-10 Dimethicone, Dicaprylyl Carbonate, Niacinamide, Disteardimonium Hectorite, Dimethicone, Magnesium Sulfate, Aluminum Hydroxide, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Phenoxyethanol, Viscum Album (Mistletoe) Leaf Extract, Centella Asiatica Extract, Portulaca Oleracea Extract, Stearic Acid, Fragrance, Polymethylsilsesquioxane, Methicone, Caprylyl Glycol, Dimethicone/Vinyl Dimethicone Crosspolymer, PEG-9 Plydimethylsiloxyethyl Dimethicone, Actinidia Chinensis (Kiwi) Fruit Extract, Camellia Sinensis Callus Culture Extract, Cucurbita Pepo (Pumpkin) Fruit Extract, Daucus Carota Sativa (Carrot) Root Extract, Glyceryl Caprylate, Mangifera Indica (Mango) Fruit Extract, Polyglyceryl-6 Plyricinoleate, Tocopheryl Acetate, Sodium Hyaluronate

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Warnings (WARNINGS)

Warnings: 1. In case of having following symptoms after using this, you’re advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In case of getting it into your eyes, you have to wash it immediately.

Keep out of reach of children: Keep out of reach of babies and children

Description (DESCRIPTION)

Indications & Usage: Apply a desired amount evenly over entire face.

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

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredient: ETHYLHEXYL METHOXYCINNAMATE 6.80%, ZINC OXIDE 5.00%, ETHYLHEXYL SALICYLATE 4.50%, TITANIUM DIOXIDE 4.00%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients: Water, Cyclopentasiloxane, Dipropylene Glycol, Peg-10 Dimethicone, Dicaprylyl Carbonate, Niacinamide, Disteardimonium Hectorite, Dimethicone, Magnesium Sulfate, Aluminum Hydroxide, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Phenoxyethanol, Viscum Album (Mistletoe) Leaf Extract, Centella Asiatica Extract, Portulaca Oleracea Extract, Stearic Acid, Fragrance, Polymethylsilsesquioxane, Methicone, Caprylyl Glycol, Dimethicone/Vinyl Dimethicone Crosspolymer, PEG-9 Plydimethylsiloxyethyl Dimethicone, Actinidia Chinensis (Kiwi) Fruit Extract, Camellia Sinensis Callus Culture Extract, Cucurbita Pepo (Pumpkin) Fruit Extract, Daucus Carota Sativa (Carrot) Root Extract, Glyceryl Caprylate, Mangifera Indica (Mango) Fruit Extract, Polyglyceryl-6 Plyricinoleate, Tocopheryl Acetate, Sodium Hyaluronate

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


Advanced Ingredient Data


Raw Label Data

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