Label: THE ORIENTAL GYEOL GOUN TWO WAY PACT- titanium dioxide, octinoxate, zinc oxide powder
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Contains inactivated NDC Code(s)
NDC Code(s): 59078-017-01 - Packager: TONYMOLY CO., LTD.
- Category: HUMAN OTC DRUG LABEL
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 August 3, 2013
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
INACTIVE INGREDIENT:
Mica (CI 77019), Talc, Alumina, Silica, Hexyl Laurate, HDI/Trimethylol Hexyllactone Crosspolymer, Dimethicone, Iron Oxides (CI 77492), Diphenyl Dimethicone/Vinyl Diphenyl Dimethicone/Silsesquioxane Crosspolymer, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Methicone, Magnesium Myristate, Hydrogenated Lecithin, Iron Oxides (CI 77491), Methylparaben, Iron Oxides (CI 77499), Propylparaben, Fragrance(Parfum), Ultramarines (CI 77007), Water, Butylene Glycol, Calcium Carbonate, Hydrolyzed Antler Velvet, Caprylic/Capric Triglyceride, Triethoxycaprylylsilane, Phenoxyethanol, Poria Cocos Extract, Rehmannia Glutinosa Root Extract, Citrus Unshiu Peel Extract, Lithospermum Erythrorhizon Root Extract, Coptis Japonica Root Extract, Glycerin, Trichosanthes Kirilowii Root Extract, Camellia Sinensis Leaf Extract, Zizyphus Jujuba Fruit Extract, Phellodendron Amurense Bark Extract, Rosa Davurica Bud Extract, Ethylhexylglycerin, Ligularia Fishceria Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Oenothera Biennis (Evening Primrose) Seed Extract, Angelica Gigas Root Extract, Prunus Mume Flower Extract, Atractyloides Japonica Rhizome Extract, Cinnamomum Cassia Bark Extract, Panax Ginseng Root Extract, Paeonia Lactiflora Root Extract, Cnidium Officinale Root Extract, Nelumbo Nucifera Flower Extract, Disodium EDTA, Prunus Mume Fruit Extract, Lactic Acid, Citric Acid - PURPOSE
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WARNINGS
Warnings:
1. In case of having following symptoms after using this, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist.
1) In case of having problems such as red rash, swollenness, itching, stimulation during usage.
2) In case of having the same symptoms above on the part you put this product on by direct sunlight.
2. You are banned to use it on the part where you have a scar, eczema, or dermatitis.
3. In case of getting it into your eyes, you have to wash it immediately. - KEEP OUT OF REACH OF CHILDREN
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
THE ORIENTAL GYEOL GOUN TWO WAY PACT
titanium dioxide, octinoxate, zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59078-017 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 2.33 g in 20 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.2 g in 20 g Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 0.59 g in 20 g Inactive Ingredients Ingredient Name Strength Mica (UNII: V8A1AW0880) Talc (UNII: 7SEV7J4R1U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59078-017-01 20 g in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/01/2013 Labeler - TONYMOLY CO., LTD. (688216798) Registrant - TONYMOLY CO., LTD. (688216798) Establishment Name Address ID/FEI Business Operations TONYMOLY CO., LTD. 688216798 manufacture(59078-017)
