Label: ESOPINIO FRESH AND CLEAR FOUNDATION SPF20- titanium dioxide cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 44781-140-01 - 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 29, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
-
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
-
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
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ESOPINIO FRESH AND CLEAR FOUNDATION SPF20
titanium dioxide creamProduct 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