DR MEDECEAN RISING SUN COVER- octinoxate, titanium dioxide, octisalate cream
INNOGENE CO.,LTD

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

Image of carton

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	09/01/2017

Labeler - INNOGENE CO.,LTD (688201056)

Registrant - INNOGENE CO.,LTD (688201056)

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