Label: MISSHA ALL AROUND SAFE BLOCK ESSENCE SUN SPF45 PA PLUS PLUS PLUS- octinoxate 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 November 22, 2011

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

  • ACTIVE INGREDIENT

    Active ingredients: Octinoxate 7%, Octisalate 4.8%, Phenylbenzimidazole Sulfonic Acid 4%

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:
    Water, Butylene Glycol, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Methyl Methacrylate Crosspolymer, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Glyceryl Stearate, Cetearyl Olivate, Sorbitan Olivate, Sodium Hydroxide, Dimethicone, Polyacrylate-13, PEG-100 Stearate, Polyisobutene, Sorbitan Stearate, Panthenol, Aloe Barbadensis Leaf Juice, Sorbitan Isostearate, Polysorbate 20, Morus Alba Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Cucumis Sativus (Cucumber) Fruit Extract, Hamamelis Virginiana (Witch Hazel) Water, Portulaca Oleracea Extract, Nelumbo Nucifera Flower Extract, Rosa Davurica Bud Extract, Camellia Sinensis Leaf Extract, Chrysanthemum Indicum flower Extract, Diospyros Kaki Leaf Extract, Pueraria Lobata Root Extract, Cinnamomum Cassia Bark Extract, Artemisia princeps Leaf Extract, Morus Alba Fruit Extract, BHT, Disodium EDTA, 1,2-Hexanediol, Caprylyl Glycol, Ethylhexylglycerin

  • PURPOSE

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

  • WARNINGS

    WARNINGS:
    For external use only.
    Do not swallow.
    Avoid contact with eyes.
    Do not use on wounds or if you are allergic to any ingredients of this product.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children:
    Keep out of reach of children.

  • INDICATIONS & USAGE

    INDICATION AND USAGE:
    - At the last step of basic skin care, apply an appropriate amount evenly over the face. Pat lightly until fully absorbed.
    - Apply evenly onto the face, neck, arms and legs where sun exposure occurs.
    - Reapply during long exposure.

  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION:
    Take appropriate amount according to your skin condition and apply every morning and night.

  • PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    MISSHA ALL AROUND SAFE BLOCK ESSENCE SUN  SPF45 PA PLUS PLUS PLUS
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13733-014
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.5 mL  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.4 mL  in 50 mL
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE2 mL  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    MORUS ALBA ROOT (UNII: CST1G9BZGD)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    CUCUMBER (UNII: YY7C30VXJT)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    PURSLANE (UNII: M6S840WXG5)  
    NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)  
    BANCHA TEA LEAF/TWIG (UNII: EWI42IEH1C)  
    DENDRANTHEMA INDICUM FLOWER (UNII: I6OER6U04L)  
    DIOSPYROS KAKI LEAF (UNII: Q71GF9OBNO)  
    PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C)  
    CHINESE CINNAMON (UNII: WS4CQ062KM)  
    ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13733-014-0150 mL in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/01/2011
    Labeler - ABLE C&C CO., LTD. (689540284)
    Registrant - ABLE C&C CO., LTD. (689540284)
    Establishment
    NameAddressID/FEIBusiness Operations
    ABLE C&C CO., LTD.689540284manufacture