SPL v1
SPL
SPL Set ID 85759f43-2903-48ff-939e-46f9661a1613
Route
TOPICAL
Published
Effective Date 2015-06-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (3.60 mg) Titanium Dioxide (2.07 mg) Octinoxate (2.00 mg) Octisalate
Inactive Ingredients
Butylene Glycol

Identifiers & Packaging

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

Description

Active Ingredient: Zinc Oxide 7.20%, Titanium Dioxide 4.15%, Ethylhexyl Methoxycinnamate 4.00%, Ethylhexyl Salicylate 4.00%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Directions & Usage: Apply liberally on face and body 15 minutes before sun exposure.

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

Active Ingredient

Active Ingredient: Zinc Oxide 7.20%, Titanium Dioxide 4.15%, Ethylhexyl Methoxycinnamate 4.00%, Ethylhexyl Salicylate 4.00%

Inactive Ingredient

Inactive Ingredients: Chamaecyparis Obtusa Water, Cyclopentasiloxane, Silica, Caprylic/Capric Triglyceride, Butylene Glycol, Alcohol Denat., PEG-10 Methyl Ether Dimethicone, Isopropyl Palmitate, C12-15 Alkyl Benzoate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Caprylyl Methicone, Dipropylene Glycol, Niacinamide, Sodium Chloride, Quaternium-18 Bentonite, PEG-10 Dimethicone, Stearalkonium Hectorite, Aluminum Hydroxide, Sorbitan Sesquioleate, Sorbitan Olivate, Stearic Acid, Polyhydroxystearic Acid, Dimethicone/Vinyl Dimethicone Crosspolymer, Phenoxyethanol, Dimethicone, Hydrogen Dimethicone, Fragrance, Water, Propylene Carbonate, Ethylhexyl Palmitate, Lecithin, Tocopheryl Acetate, Isostearic Acid, Sodium Benzoate, Polyglyceryl-3 Polyricinoleate, Disodium EDTA, Potassium sorbate, Adenosine, Prunus armeniaca (apricot) fruit extract, Melaleuca Alternifolia (Tea Tree) Leaf Water, Citrus Limon (Lemon) Fruit Extract, Portulaca Oleracea Extract, Pyrus Malus (Apple) Fruit Extract, Citrus aurantium dulcis (orange) fruit extract, Centella Asiatica Extract, Pentylene Glycol, Caprylyl Glycol, 1,2-Hexanediol, Ethylhexylglycerin

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

Description (DESCRIPTION)

Directions & Usage: Apply liberally on face and body 15 minutes before sun exposure.

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

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredient: Zinc Oxide 7.20%, Titanium Dioxide 4.15%, Ethylhexyl Methoxycinnamate 4.00%, Ethylhexyl Salicylate 4.00%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients: Chamaecyparis Obtusa Water, Cyclopentasiloxane, Silica, Caprylic/Capric Triglyceride, Butylene Glycol, Alcohol Denat., PEG-10 Methyl Ether Dimethicone, Isopropyl Palmitate, C12-15 Alkyl Benzoate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Caprylyl Methicone, Dipropylene Glycol, Niacinamide, Sodium Chloride, Quaternium-18 Bentonite, PEG-10 Dimethicone, Stearalkonium Hectorite, Aluminum Hydroxide, Sorbitan Sesquioleate, Sorbitan Olivate, Stearic Acid, Polyhydroxystearic Acid, Dimethicone/Vinyl Dimethicone Crosspolymer, Phenoxyethanol, Dimethicone, Hydrogen Dimethicone, Fragrance, Water, Propylene Carbonate, Ethylhexyl Palmitate, Lecithin, Tocopheryl Acetate, Isostearic Acid, Sodium Benzoate, Polyglyceryl-3 Polyricinoleate, Disodium EDTA, Potassium sorbate, Adenosine, Prunus armeniaca (apricot) fruit extract, Melaleuca Alternifolia (Tea Tree) Leaf Water, Citrus Limon (Lemon) Fruit Extract, Portulaca Oleracea Extract, Pyrus Malus (Apple) Fruit Extract, Citrus aurantium dulcis (orange) fruit extract, Centella Asiatica Extract, Pentylene Glycol, Caprylyl Glycol, 1,2-Hexanediol, Ethylhexylglycerin

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)