Label: ESOPINIO SUN SHIELD PLUS SPF 35 PA- titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 44781-110-01 - Packager: ZION SYNTHETIC FIBER CO., LTD.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated August 28, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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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
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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
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ESOPINIO SUN SHIELD PLUS SPF 35 PA
titanium dioxide creamProduct 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