Label: SUPREME SKINPIA 10 SUN BLOCK- octinoxate, zinc oxide, titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 62242-010-01 - Packager: EBAIN Corporation Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 March 4, 2014
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, Cyclopentasiloxane, Cyclomethicone, Propylene Glycol, Glycerin, Dimethicone, Isononyl Isononanoate, 4-Methylbenzylidene Camphor, PEG-10 Dimethicone, Polymethyl Methacrylate, 1,2-Hexanediol, Triethanolamine, Sorbitan Sesquioleate, Magnesium Sulfate,
Disteardimonium Hectorite, Stearic Acid, Aluminum Hydroxide, Betaine, Phenoxyethanol, Dimethicone/Vinyl Dimethicone Crosspolymer, Allantoin, Saccharomyces/Viscum Album (Mistletoe) Ferment Extract, Lactobacillus/Soybean Ferment Extract, Saccharomyces/Imperata Cylindrica Root Ferment Extract, Aloe Barbadensis Leaf Juice Powder, Dipotassium Glycyrrhizate, Butylene Glycol, Larix Sibirica Wood Extract, Chrysanthellum Indicum Extract, Rheum Palmatum Root/Stalk Extract, Asarum Sieboldi Root Extract, Quercus Mongolia Leaf Extract , Persicaria Hydropiper Extract, Illicium Verum (Anise) Fruit Extract, Corydalis Turtschaninovii Root Extract, Coptis Japonica Root Extract, Machilus Thunbergii Bark Extract, Sarcodon Aspratus Extract, Lepidium Meyenii Root Extract, Ethylhexylglycerin, Portulaca Oleracea Extract, Fomes Officinalis (Mushroom) Extract, PEG-40 Hydrogenated Castor Oil, Sodium Hyaluronate, Polyglutamic Acid - PURPOSE
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WARNINGS
Warnings:
1. 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 haviong 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.
2. You are banned to use it on the part where you have a scar, eczema, or dermatitis.
3. In case of getting it into your eyes, you have to wash it immediately. - KEEP OUT OF REACH OF CHILDREN
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUPREME SKINPIA 10 SUN BLOCK
octinoxate, zinc oxide, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62242-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate 3.5 mg in 50 mL Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 1.5 mg in 50 mL Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 1.5 mg in 50 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Propylene Glycol (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62242-010-01 50 mL in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/02/2014 Labeler - EBAIN Corporation Co., Ltd. (689048989) Registrant - EBAIN Corporation Co., Ltd. (689048989) Establishment Name Address ID/FEI Business Operations EBAIN Corporation Co., Ltd. 689048989 manufacture(62242-010)
