Label: MISSHA GLAM SILKY BODY BALM SPF 27- titanium dioxide, octinoxate, zinc oxide 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 29, 2012

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS: Titanium Dioxide 7.54%, Ethylhexyl Methoxycinnamate 6.00%, Zinc Oxide 1.92%

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:
    Cetyl Ethylhexanoate, Octyldodecyl Myristate, Mica, Polyethylene, Zea Mays (Corn) Starch, Microcrystalline Wax, 4-Methylbenzylidene Camphor, Punica Granatum Seed Oil, Camellia Sinensis Seed Oil, Vitis Vinifera (Grape) Seed Oil, Prunus Armeniaca (Apricot) Kernel Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Talc, Methicone, Hydrogen Dimethicone, BHT, Tin Oxide, Carmine, Caprylyl Glycol, Ethylhexylglycerin, Fragrance

  • PURPOSE

    PURPOSE: This combination of Cosmetic / OTC Drug can be used as a sun protection cream

  • 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: Apply as desired with encased puff.

  • DOSAGE AND ADMINISTRATION

    DOSAGE AND ADMINISTRATION: Use appropriate amount according to your skin condition and apply as you desire.

  • PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    MISSHA GLAM SILKY BODY BALM  SPF 27
    titanium dioxide, octinoxate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13733-016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.88 g  in 25 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.5 g  in 25 g
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.48 g  in 25 g
    Inactive Ingredients
    Ingredient NameStrength
    Cetyl Ethylhexanoate (UNII: 134647WMX4)  
    Octyldodecyl Myristate (UNII: S013N99GR8)  
    Mica (UNII: V8A1AW0880)  
    Talc (UNII: 7SEV7J4R1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13733-016-0125 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(13733-016)
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