ESOPINIO FRESH AND CLEAR FOUNDATION SPF20 - titanium dioxide cream 
ZION SYNTHETIC FIBER 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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Drug Facts

Active ingredient: TITANIUM DIOXIDE

Inactive ingredients:

Water, Cyclomethicone, Butylene Glycol, Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Cyclomethicone/Dimethicone Crosspolymer, Butylene Glycol Dicaprylate/Dicaprate, Glycerin, Carbomer, Polysorbate 20, Palmitoyl Pentapeptide-4, Polyglyceryl-4-Isostearate, Silica, Ethylhexyl Methoxycinnamate, Micronized Titanium Dioxide Aluminum Hydroxide Stearic Acid, Sodium Chloride, Portulaca Oleracea Extract, Zinc Stearate, Betaine, Silica Dimethyl Silylate, Iron Oxide, Butyl Paraben, Methyl Paraben, Tocopheryl Acetate, Allantoin, Flavor, Anthemis Nobilis Flower Extract, Punica Granatum Extract, Vitis Vinifera(Grape) Seed Extract, Hematite Extract, Aluminum Silicate, Topaz, Amethyst Powder, Zeolite

Purpose: It protects the skin from UV rays, pollution and dust.

Warnings:
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.
- In case of having problems such as red rash, swollenness, itching, stimulation during usage.
- In case of having the same symptoms above on the part you put this product on by direct sunlight.
You are banned to use it on the part where you have a scar, eczema, or dermatitis.
In case of getting it into your eyes, you have to wash it immediately.

Keep out of reach of children:

Keep out of the reach of babies and children.

Indications and usage:
Tighten the lid after using it.
Don't keep it in the place where the temperature is extremely hot or low and exposed the direct sunlight.
Use it at the time before you're going out after applying the Animating Water Cream.

Dosage and administration:
Take up about  0.3g - 0.5g of it  and smooth over the entire face.

Image of carton
ESOPINIO FRESH AND CLEAR FOUNDATION  SPF20
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44781-140
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE3.5 g  in 35 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Cyclomethicone (UNII: NMQ347994Z)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Dimethicone (UNII: 92RU3N3Y1O)  
Glycerin (UNII: PDC6A3C0OX)  
CARBOMER 934 (UNII: Z135WT9208)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
OCTINOXATE (UNII: 4Y5P7MUD51)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ZINC STEARATE (UNII: H92E6QA4FV)  
BETAINE (UNII: 3SCV180C9W)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ALLANTOIN (UNII: 344S277G0Z)  
CHAMAEMELUM NOBILE (UNII: 7NF3GE7IWR)  
WINE GRAPE (UNII: 3GOV20705G)  
ALUMINUM SILICATE (UNII: T1FAD4SS2M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44781-140-0135 g in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2010
Labeler - ZION SYNTHETIC FIBER CO., LTD. (688011147)
Registrant - ZION SYNTHETIC FIBER CO., LTD. (688011147)
Establishment
NameAddressID/FEIBusiness Operations
ZION SYNTHETIC FIBER CO., LTD.688011147manufacture

Revised: 8/2011
Document Id: e2ff4509-12eb-46a9-9a2f-e1b36786e09a
Set id: 356f526b-d402-41e6-a8b5-339b8c610dd1
Version: 2
Effective Time: 20110829
 
ZION SYNTHETIC FIBER CO., LTD.