Label: MISSHA SIGNATURE EXTREME COVER CONCEALER NO.23 SPF30 PA PLUS PLUS- titanium dioxide cream

  • 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 October 30, 2012

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT: Titanium Dioxide 22.87%

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:
    Petrolatum, Trimethylolpropane Tricaprylate/Tricaprate, Mica, Isotridecyl Isononanoate, Boron Nitride, Triethylhexanoin, Polyethylene, Silica Silylate, Lauroyl Lysine, Trimethylsiloxysilicate, Glycerin,Fullerenes, Imperata Cylindrica Root Extract, Iris Versicolor Extract, Lilium Candidum Bulb Extract, Leontopodium Alpinum Flower/Leaf Extract, Nelumbo Nucifera Flower Extract, Rose Extract, Jasminum Officinale (Jasmine) Flower/Leaf Extract, Freesia Refracta Extract, Narcissus Pseudo-Narcissus (Daffodil) Flower Extract, Viscum Album (Mistletoe) Extract, Melissa Officinalis Leaf Extract, Leucojum Aestivum Bulb Extract, Chrysanthemum Indicum Flower Extract, Origanum Majorana Leaf Extract, Camellia Sinensis Leaf Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Aspalathus Linearis Extract, Thymus Vulgaris (Thyme) Extract, Pelargonium Graveolens Extract, Mentha Rotundifolia Leaf Extract, Origanum Vulgare Leaf Extract, Eucalyptus Globulus Leaf Extract, Jasminum Officinale (Jasmine) Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Thymus Vulgaris (Thyme) Leaf Extract, Mentha Spicata Flower/Leaf/Stem Extract, Rosmarinus Officinalis (Rosemary) Extract, Bertholletia Excelsa Seed Oil, Argania Spinosa Kernel Oil, Plukenetia Volubilis Seed Oil, Calophyllum Inophyllum Seed Oil, Macadamia Ternifolia Seed Oil, Butyrospermum Parkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Theobroma Grandiflorum Seed Butter, Tocopheryl Acetate, Squalane, Microcrystalline Wax, VP/Hexadecene Copolymer, Cyclopentasiloxane, Aluminum Hydroxide, Cyclohexasiloxane, Sorbitan Sesquiisostearate, Sorbitan Isostearate, Methicone, Caprylyl Glycol, Polydecene, Water, Butylene Glycol, Silica, Polyvinylalcohol Crosspolymer, PEG-8, PVP, Nylon-12 Fluorescent Brightener 230 Salt, Hydrogenated Lecithin, Polyurethane-40, Ceramide 3, Cholesterol, Stearic Acid, Dimethicone, Oleic Acid, Brassica Campestris (Rapeseed) Sterols, Tocopherol, Carbomer, Phenoxyethanol, Fragrance(Parfum), Iron Oxides

  • PURPOSE

    PURPOSE: This combination of Cosmetic / OTC Drug can be used as a sun protection cream, and as a cosmetic to cover your blemishes / scar and to tone up your skin care.

  • WARNINGS

    WARNING:
    For external use only.
    Do not swallow.
    Keep out of reach of children.
    Avoid contact with eyes.
    Do not use on exposed wounds or if you are allergic to any ingredients of this product.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS AND USAGE

    INDICATION AND USAGE:
    After using BB cream or foundation, take an appropriate amount on the brush and apply over the face.
    Pat with finger tips for better adherence.

    - TIPS :
    1) To cover small area: Take an appropriate amount on the brush and dot it on the area and pat with finger tips for better adherence.
    2) To cover large area: Take an appropriate amount on the brush and spread it over the area and pat with finger tips for better adherence.

  • DOSAGE AND ADMINISTRATION

    DOSAGE AND ADMINISTRATION:
    Take appropriate amount according to your skin condition and apply as you desire.
    Remove it before sleeping.

  • PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    MISSHA SIGNATURE EXTREME COVER CONCEALER  NO.23 SPF30 PA PLUS PLUS
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13733-018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.28 g  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    Petrolatum (UNII: 4T6H12BN9U)  
    Mica (UNII: V8A1AW0880)  
    Isotridecyl Isononanoate (UNII: WEF51750MT)  
    Boron Nitride (UNII: 2U4T60A6YD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13733-018-0110 g in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/01/2012
    Labeler - ABLE C&C CO., LTD. (689540284)
    Registrant - ABLE C&C CO., LTD. (689540284)
    Establishment
    NameAddressID/FEIBusiness Operations
    ABLE C&C CO., LTD.689540284manufacture(13733-018)