DONGINBI RED GINSENG PERFECT SUN- octinoxate, octisalate, zinc oxide, titanium dioxide cream 
KGC LIFE&GIN

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 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

Image of carton

DONGINBI RED GINSENG  PERFECT SUN
octinoxate, octisalate, zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69640-4001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate3.75 g  in 50 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate2.5 g  in 50 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2.45 g  in 50 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.45 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69640-4001-21 in 1 CARTON03/08/2015
1NDC:69640-4001-150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/08/2015
Labeler - KGC LIFE&GIN (689680259)
Registrant - KGC LIFE&GIN (689680259)
Establishment
NameAddressID/FEIBusiness Operations
KGC LIFE&GIN689680259relabel(69640-4001)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc689049693manufacture(69640-4001)

Revised: 7/2017
Document Id: 7a1d09d3-7e2d-4434-a00f-fc7eb29cd0ca
Set id: 4ad83e74-b8fc-430d-abf9-01f8c09f1337
Version: 1
Effective Time: 20170726
 
KGC LIFE&GIN