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ESOPINIO FRESH AND CLEAR FOUNDATION SPF20

Dosage form: cream
Ingredients: TITANIUM DIOXIDE 3.5g in 35g
Labeler: ZION SYNTHETIC FIBER CO., LTD.
NDC Code: 44781-140

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 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.

ESOPINIO FRESH AND CLEAR FOUNDATION  SPF20
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44781-140
Route of AdministrationCUTANEOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM) TITANIUM DIOXIDE3.5 g  in 35 g
Inactive Ingredients
Ingredient NameStrength
Water 
Cyclomethicone 
Butylene Glycol 
Dimethicone 
Glycerin 
CARBOMER 934 
POLYSORBATE 20 
SILICON DIOXIDE 
OCTINOXATE 
STEARIC ACID 
ALUMINUM HYDROXIDE 
SODIUM CHLORIDE 
ZINC STEARATE 
BETAINE 
BUTYLPARABEN 
METHYLPARABEN 
ALLANTOIN 
CHAMAEMELUM NOBILE 
WINE GRAPE 
ALUMINUM SILICATE 
Packaging
#Item CodePackage Description
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/FEIOperations
ZION SYNTHETIC FIBER CO., LTD.688011147manufacture

Revised: 08/2011
 
ZION SYNTHETIC FIBER CO., LTD.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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