THE ORIENTAL GYEOL GOUN TWO WAY PACT- titanium dioxide, octinoxate, zinc oxide powder 
TONYMOLY 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: Titanium Dioxide 11.64%, Ethylhexyl Methoxycinnamate 6.00%, Zinc Oxide 2.94%

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

PURPOSE: SUNSCREEN

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

Keep out of reach of children:
Keep out of reach of babies and children

INDICATIONS AND USAGE

INDICATIONS AND USAGE: After base make-up, apply powder to the puff and apply gently. Application order : Chick - Forehead - Nose - Chin

DOSAGE AND ADMINISTRATION

DOSAGE AND ADMINISTRATION: Take an adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

THE ORIENTAL GYEOL GOUN TWO WAY PACT 
titanium dioxide, octinoxate, zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-017
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide2.33 g  in 20 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.2 g  in 20 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.59 g  in 20 g
Inactive Ingredients
Ingredient NameStrength
Mica (UNII: V8A1AW0880)  
Talc (UNII: 7SEV7J4R1U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59078-017-0120 g in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/01/2013
Labeler - TONYMOLY CO., LTD. (688216798)
Registrant - TONYMOLY CO., LTD. (688216798)
Establishment
NameAddressID/FEIBusiness Operations
TONYMOLY CO., LTD.688216798manufacture(59078-017)

Revised: 8/2013
Document Id: 01c811fa-fc51-4841-b7a6-555a32be5a2e
Set id: 8be3d0f5-1ce6-48c4-8599-1be07012196c
Version: 1
Effective Time: 20130803
 
TONYMOLY CO., LTD.