DONGINBI RED GINSENG PERFECT SUN- octinoxate, octisalate, zinc oxide, titanium dioxide cream

DONGINBI Red Ginseng by

Drug Labeling and Warnings

DONGINBI Red Ginseng by is a Otc medication manufactured, distributed, or labeled by KGC LIFE&GIN, Cosmax, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Ethylhexyl Methoxycinnamate 7.5%, Ethylhexyl Salicylate 5.0%, Zinc Oxide 4.9%, Titanium Dioxide 2.9%

INACTIVE INGREDIENT

Inactive ingredients: Water, Cyclopentasiloxane, Butylene Glycol, Dipropylene Glycol, Glycerin, PEG-10 Dimethicone, Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Disteardimonium Hectorite, Magnesium Sulfate, Isoamyl p-Methoxycinnamate, Glyceryl Caprylate, Fragrance(Parfum), Aluminum Hydroxide, Stearic Acid, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Glycol, Ecklonia Cava Extract, Panax Ginseng Root Extract, Saccharide Isomerate, Ginsenosides, Camellia Sinensis Leaf Extract, Honey Extract, Portulaca Oleracea Extract, Cinnamomum Cassia Bark Extract, Chaenomeles Sinensis Fruit Extract, Citrus Aurantifolia (Lime) Fruit Extract, Chrysanthemum Indicum Flower Extract, Phenoxyethanol, Cnidium Officinale Root Extract, Methylparaben, Butylparaben, Ethylparaben, Isobutylparaben, Propylparaben

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap after use.

Keep Out of Reach of Children: Do not use on hurt or abraded skin.

DESCRIPTION

Uses: Apply an appropriate amount to your face then apply it along the skin texture, thin and wide, finish with massage.

Directions: in the morning, as the last step in your basic routine, lightly apply a desired amount to your entire face.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DONGINBI RED GINSENG  PERFECT SUN
octinoxate, octisalate, zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69640-4001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	3.75 g  in 50 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	2.5 g  in 50 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	2.45 g  in 50 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	1.45 g  in 50 mL

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: 69640-4001-2	1 in 1 CARTON	03/08/2015
1	NDC: 69640-4001-1	50 mL in 1 TUBE; 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	03/08/2015

Labeler - KGC LIFE&GIN (689680259)

Registrant - KGC LIFE&GIN (689680259)

Establishment
Name	Address	ID/FEI	Business Operations
KGC LIFE&GIN		689680259	relabel(69640-4001)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc		689049693	manufacture(69640-4001)