DR MEDECEAN RISING SUN COVER- octinoxate, titanium dioxide, octisalate cream

Dr MEDECEAN Rising Sun Cover by

Drug Labeling and Warnings

Dr MEDECEAN Rising Sun Cover by is a Otc medication manufactured, distributed, or labeled by INNOGENE CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PURPOSE

Purpose: Sunscreen

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

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR MEDECEAN RISING SUN COVER 
octinoxate, titanium dioxide, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70540-040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	4.0 g  in 50 g
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	1.5 g  in 50 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	1.0 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70540-040-02	1 in 1 CARTON	09/01/2017
1	NDC: 70540-040-01	50 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2017

Labeler - INNOGENE CO.,LTD (688201056)

Registrant - INNOGENE CO.,LTD (688201056)

Establishment
Name	Address	ID/FEI	Business Operations
INNOGENE CO.,LTD		688201056	manufacture(70540-040)