ESOPINIO FRESH AND CLEAR FOUNDATION SPF20- titanium dioxide cream

ESOPINIO FRESH AND CLEAR FOUNDATION by

Drug Labeling and Warnings

ESOPINIO FRESH AND CLEAR FOUNDATION by is a Otc medication manufactured, distributed, or labeled by ZION SYNTHETIC FIBER CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient: TITANIUM DIOXIDE

INACTIVE INGREDIENT

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

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

WARNINGS

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 reach of children:

Keep out of the reach of babies and children.

INDICATIONS & USAGE

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 & ADMINISTRATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ESOPINIO FRESH AND CLEAR FOUNDATION  SPF20
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44781-140
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE)	TITANIUM DIOXIDE	3.5 g  in 35 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44781-140-01	35 g in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/01/2010

Labeler - ZION SYNTHETIC FIBER CO., LTD. (688011147)

Registrant - ZION SYNTHETIC FIBER CO., LTD. (688011147)

Establishment
Name	Address	ID/FEI	Business Operations
ZION SYNTHETIC FIBER CO., LTD.		688011147	manufacture