Label: SUPREME SKINPIA 10 BB- titanium dioxide, zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL

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

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  • ACTIVE INGREDIENT

    Active Ingredients: Titanium Dioxide 10%, Zinc Oxide 0.6%

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Water, Cyclopentasiloxane, Phenyl Trimethicone, Caprylic/Capric Triglyceride, Cyclohexasiloxane, Butylene Glycol Dicaprylate/Dicaprate, Dicaprylyl Carbonate, Glycerin, Cetyl PEG/PPG-10/1 Dimethicone, Niacinamide, Sodium Chloride, Stearic Acid, Pentylene Glycol,
    Sorbitan Isostearate, Aluminum Hydroxide, Methyl Methacrylate Crosspolymer, Beeswax, Persicaria Hydropiper Extract, 1,2-Hexanediol, Butylene Glycol, Phenoxyethanol, CI 77492, Stearalkonium Hectorite, Dimethicone Crosspolymer, Dimethiconol, Fragrance, Caprylhydroxamic Acid, CI 77491, Portulaca Oleracea Extract, Ultramarines, Coptis Japonica Root Extract, Corydalis Turtschaninovii Root Extract, Quercus Mongolia Leaf Extract, Larix Sibirica Wood Extract, Asarum Sieboldi Root Extract, Rheum Palmatum Root/Stalk Extract, Chrysanthellum Indicum Extract, Illicium Verum (Anise) Fruit Extract, Machilus Thunbergii Bark Extract, CI 77499, Disodium EDTA, Fomes Officinalis (Mushroom) Extract, Triethoxycaprylylsilane, Talc, Hydrogen Dimethicone, Ethylhexylglycerin, Lepidium Meyenii Root Extract,
    Sarcodon Aspratus Extract, Sodium Hyaluronate, PEG-40 Hydrogenated Castor Oil, Polyglutamic Acid

  • PURPOSE

    Purpose: Sunscreen

  • 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

    Keep out of reach of children: Keep out of reach of babies and children

  • INDICATIONS AND USAGE

    Indications and usage: After basic skin care, apply adequate amount following the skin texture and gently tap to enhance absorption.

  • DOSAGE AND ADMINISTRATION

    Dosage and administration: Take an adequate amount of this product.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    SUPREME SKINPIA 10 BB 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62242-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide5 mg  in 50 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.3 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62242-020-0150 mL in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/02/2014
    Labeler - EBAIN Corporation Co., Ltd. (689048989)
    Registrant - EBAIN Corporation Co., Ltd. (689048989)
    Establishment
    NameAddressID/FEIBusiness Operations
    EBAIN Corporation Co., Ltd.689048989manufacture(62242-020)