SPL v1
SPL
SPL Set ID 6f39af01-b996-426d-8d93-33ff52a21238
Route
TOPICAL
Published
Effective Date 2017-09-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (4.0 g) Titanium Dioxide (1.5 g) Octisalate (1.0 g)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-09-01

Description

Active ingredients: Ethylhexyl Methoxycinnamate 8.0%, Titanium Dioxide 3.0%, Ethylhexyl Salicylate 2.0%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Uses: Dr.MEDECEAN Rising Sun Cover Cream will protect your sensitive skin from the Sun.

Directions: Apply an appropriate amount to the exposed skin when you need.

Warnings

Warnings: For external use only

1. If the Red swellings such as erythema, itchiness, or irritations because of directly sunlight occur, you must stop using immediately and Consult your dermatologist. 2. Do not apply on skin conditions such as wounds. 3. Storage and Handling. a. Keep out of the reach of children. b. Avoid direct sunlight.

Active Ingredient

Active ingredients: Ethylhexyl Methoxycinnamate 8.0%, Titanium Dioxide 3.0%, Ethylhexyl Salicylate 2.0%

Inactive Ingredient

Inactive ingredients: Water, Butylene Glycol, Dibutyl Adipate, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Pentylene Glycol, Glycerin, Cyclopentasiloxane, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Cyclohexasiloxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Arachidyl Alcohol, Polysorbate 60, Stearic Acid, Glyceryl Stearate, PEG-100 Stearate, Allantoin, Oleth-10, Behenyl Alcohol, Aluminum Hydroxide, Triethoxycaprylylsilane, Mannitol, Ammonium Acryloyldimethyltaurate/VP Copolymer, Arachidyl Glucoside, 1,2-Hexanediol, Chlorphenesin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ammonium Glycyrrhizate, Triethanolamine, Coco-glucoside, Citric acid, Adenosine, Disodium EDTA, Laureth-4, Caffeine, Zinc Gluconate, BHT, Sorbic Acid, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Acetyl Tetrapeptide-15

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Warnings (WARNINGS)

Warnings: For external use only

1. If the Red swellings such as erythema, itchiness, or irritations because of directly sunlight occur, you must stop using immediately and Consult your dermatologist. 2. Do not apply on skin conditions such as wounds. 3. Storage and Handling. a. Keep out of the reach of children. b. Avoid direct sunlight.

Description (DESCRIPTION)

Uses: Dr.MEDECEAN Rising Sun Cover Cream will protect your sensitive skin from the Sun.

Directions: Apply an appropriate amount to the exposed skin when you need.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Ethylhexyl Methoxycinnamate 8.0%, Titanium Dioxide 3.0%, Ethylhexyl Salicylate 2.0%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients: Water, Butylene Glycol, Dibutyl Adipate, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Pentylene Glycol, Glycerin, Cyclopentasiloxane, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Cyclohexasiloxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Arachidyl Alcohol, Polysorbate 60, Stearic Acid, Glyceryl Stearate, PEG-100 Stearate, Allantoin, Oleth-10, Behenyl Alcohol, Aluminum Hydroxide, Triethoxycaprylylsilane, Mannitol, Ammonium Acryloyldimethyltaurate/VP Copolymer, Arachidyl Glucoside, 1,2-Hexanediol, Chlorphenesin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ammonium Glycyrrhizate, Triethanolamine, Coco-glucoside, Citric acid, Adenosine, Disodium EDTA, Laureth-4, Caffeine, Zinc Gluconate, BHT, Sorbic Acid, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Acetyl Tetrapeptide-15

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


Advanced Ingredient Data


Raw Label Data

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