ESOPINIO SUN SHIELD PLUS SPF 35 PA- titanium dioxide cream

ESOPINIO SUN SHIELD PLUS by

Drug Labeling and Warnings

ESOPINIO SUN SHIELD PLUS 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 Ingredients: TITANIUM DIOXIDE, ZINC OXIDE

INACTIVE INGREDIENT

Inactive ingredients:

Water, Ethylhexyl Methoxycinnamate, Butylene Glycol, C12-15 Alkyl Benzoate, Cyclomethicone, Disteardimonium Hectorite, Glycerin, Cetyl PEG/PPG-10/1 Dimethicone,
Butylene Glycol Dicaprylate/Dicaprate, Bis-Ethylhexyloxyphenol Methoxyphenyltriazine, 4-Methylbenzylidene Camphor, Betaine, Sodium Chloride, Polyglyceryl-4-Isostearate,
Cetyl Dimethicone, Polymethyl Methacrylate, Dimethicone, Aluminum Hydroxide, Stearic Acid, Zinc Stearate, Portulaca Oleracea Extract, Methyl Paraben,
Tocopheryl Acetate, Allantoin, Punica Granatum Fruit Extract, Solanum Lycopersicum (Tomato) Fruit Extract, Disodium EDTA, Aluminum Silicate,
Zeolite, Topaz, Hematite Extract, Tourmaline, Flavor

PURPOSE

Purpose:
Protects your skin from Ultra-violet Rays.
365 days with Esopinio Sun Shield Plus your skin will be safe.

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 reach of 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.
Please apply it an adequate quantity  evenly on face, throat, arms and legs at the last stage of basic makeup.
Please apply it once again on your skin at the time when you're going out, sports activity, and any activities of outside.

DOSAGE & ADMINISTRATION

Dosage and Administration:
Take up about 1.2g - 1.5g of it and smooth over the entire face.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ESOPINIO SUN SHIELD PLUS  SPF 35 PA
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44781-110
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE)	TITANIUM DIOXIDE	2.55 mL  in 70 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	Zinc Oxide	1.4 mL  in 70 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
OCTINOXATE (UNII: 4Y5P7MUD51)
Butylene Glycol (UNII: 3XUS85K0RA)
Cyclomethicone (UNII: NMQ347994Z)
Glycerin (UNII: PDC6A3C0OX)
Betaine (UNII: 3SCV180C9W)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
Dimethicone (UNII: 92RU3N3Y1O)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
ZINC STEARATE (UNII: H92E6QA4FV)
METHYLPARABEN (UNII: A2I8C7HI9T)
ALLANTOIN (UNII: 344S277G0Z)
TOMATO (UNII: Z4KHF2C175)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALUMINUM SILICATE (UNII: T1FAD4SS2M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44781-110-01	70 mL 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