Label: DONGINBI RED GINSENG PERFECT SUN- octinoxate, octisalate, zinc oxide, titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69640-4001-1, 69640-4001-2 - Packager: KGC LIFE&GIN
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated July 26, 2017
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- ACTIVE INGREDIENT
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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
- WARNINGS
- DESCRIPTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DONGINBI RED GINSENG PERFECT SUN
octinoxate, octisalate, zinc oxide, titanium dioxide creamProduct 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)