Label: MISSHA SIGNATURE DRAMATIC WHITENING PACT NO.2 SPF50 PLUS PA PLUS PLUS PLUS- titanium dioxide, octinoxate, zinc oxide powder

  • 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 25, 2012

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

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:
    Titanium Dioxide 16.71%, Ethylhexyl Methoxycinnamate 6.00%, Zinc Oxide 2.94%

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:
    Mica, Talc, Silica, Dimethicone/Vinyl Dimethicone Crosspolymer, Nylon-12, Boron Nitride, Dimethicone, Methicone, Methyl Methacrylate Crosspolymer, Lauroyl Lysine, Phenyl Trimethicone, Pentaerythrityl Tetraisostearate, Iron Oxides, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Triethoxycaprylylsilane, Ethylhexylglycerin, Glyceryl Caprylate, Aluminum Hydroxide, Glycyrrhiza Glabra (Licorice) Root Extract, Hydroxypropyl Bispalmitamide MEA, Ultramarines (CI 77007), Water, Fragrance(Parfum), Zea Mays (Corn) Starch, Hydroxyapatite, Saccharomyces Lysate Extract, Phenoxyethanol, Butylene Glycol, Sodium Hyaluronate, Betula Platyphylla Japonica Juice, Nelumbo Nucifera Flower Water, HDI/Trimethylol Hexyllactone Crosspolymer, Propylene Glycol, Acacia Senegal Gum, Tin Oxide, Dipropylene Glycol, Rosmarinus Officinalis (Rosemary) Extract, Sodium Palmitoyl Proline, Lavandula Angustifolia (Lavender) Extract, Thymus Vulgaris (Thyme) Extract, Origanum Vulgare Leaf/Flower/Stem Extract, Hydrolyzed Rhizobian Gum, Camellia Sinensis Leaf Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Melissa Officinalis Leaf Extract, Rosa Canina Fruit Extract, Aspalathus Linearis Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Nymphaea Alba Flower Extract, Hibiscus Sabdariffa Flower Extract, Euterpe Oleracea Fruit Extract, Sigesbeckia Orientalis Extract, Alchemilla Vulgaris Leaf Extract, Rabdosia Rubescens Extract, Hydrolyzed Myrtus Communis Leaf Extract, Hydrogenated Lecithin, Lilium Candidum Flower Extract, Iris Versicolor 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, Sophora Angustifolia Root Extract, Saururus Chinensis Leaf/Root Extract, Poncirus Trifoliata Fruit Extract, Caprylyl Glycol, Acanthopanax Senticosus (Eleuthero) Root Extract, Diospyros Kaki Leaf Extract, Viscum Album (Mistletoe) Extract, Oenothera Biennis (Evening Primrose) Flower Extract, Angelica Gigas Root Extract, Adenophora Stricta Root Extract, Zizyphus Jujuba Fruit Extract, Codonopsis Lanceolata Root Extract, Eucommia Ulmoides Extract, Polygonum Odoratum Extract, Sorbus Commixta Extract, Portulaca Oleracea Extract, Oenanthe Javanica Extract, Morus Bombycis Leaf Extract, Cornus Officinalis Fruit Extract, Cuscuta Japonica Seed Extract, Cirsium (Thistle) Flower/Leaf/Stem Extract, Schizandra Chinensis Fruit Extract, Leonurus Sibiricus Flower/Leaf/Stem Extract, Crataegus Cuneata Fruit Extract, Xanthium Strumarium Fruit Extract, Pueraria Thunbergiana Root Extract, Polygonum Multiflorum Root Extract, Eclipta Prostrata Extract, Astragalus Membranaceus Root Extract, Rubus Coreanus Fruit Extract, Saururus Chinensis Extract, Taraxacum Platycarpum Extract, Hydrolyzed Codonopsis Pilosula Root Extract, Aralia Elata Branch/Leaf Extract, Kalopanax Pictus Extract, Lactuca Indica Extract, Cinnamomum Cassia Bark Extract, Glycerin, Caprylhydroxamic Acid

  • PURPOSE

    PURPOSE:
    This combination of Cosmetic / OTC Drug can be used as for sun protection 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 foundation or BB cream, take an appropriate amount with encased puff and apply it evenly and lightly on face.

  • DOSAGE AND ADMINISTRATION

    DOSAGE AND ADMINISTRATION:
    Use 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 DRAMATIC WHITENING PACT  NO.2 SPF50 PLUS PA PLUS PLUS PLUS
    titanium dioxide, octinoxate, zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13733-015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.84 g  in 11 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.66 g  in 11 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.32 g  in 11 g
    Inactive Ingredients
    Ingredient NameStrength
    Dimethicone (UNII: 92RU3N3Y1O)  
    Glyceryl Caprylate (UNII: TM2TZD4G4A)  
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13733-015-0111 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(13733-015)