Label: GOLDKIWI SUN SPF50 PLUS PA 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 September 7, 2011

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  • ACTIVE INGREDIENT

    Active ingredients: OCTINOXATE 7.5%, ZINC OXIDE 4.90%, TITANIUM DIOXIDE 2.90%

  • INACTIVE INGREDIENT

    Inactive ingredients:
    Water, Cyclopentasiloxane, Ethylhexyl Salicylate, Glycerin, PEG-10 Dimethicone, Dimethicone, Dipropylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Magnesium Sulfate, Disteardimonium Hectorite, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Isoamyl p-Methoxycinnamate, Dimethicone/Vinyl Dimethicone Crosspolymer, Aluminum Hydroxide, Stearic Acid, Methyl Methacrylate Crosspolymer, Methylparaben, Phenoxyethanol, Fragrance(Parfum), Actinidia Chinensis (Kiwi) Fruit Extract, Propylparaben, Caffeine, Sea Water, Polydecene, Squalane, Viscum Album (Mistletoe) Extract, Palmitoyl Tripeptide-5

  • PURPOSE

    Purpose: Protects skin from UV rays.

  • WARNINGS

    Warnings:
    For external use only. Avoid contact with eyes.
    Discontinue use if signs of irritation appear.

  • 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 end of basic cosmetic care, apply in an adequate amount to body parts sensitive to UV radiation such as face, arms and legs, avoiding the eye area.

  • DOSAGE & ADMINISTRATION

    Dosage and administration:
    Apply about 15 to 20 minutes before going out.
    Reapply as often as possible for a long-term outing or activities.

  • PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    GOLDKIWI SUN  SPF50 PLUS PA PLUS PLUS
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76214-013
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.75 g  in 50 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC OXIDE2.45 g  in 50 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE1.45 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    KIWI FRUIT (UNII: 71ES77LGJC)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CAFFEINE (UNII: 3G6A5W338E)  
    SQUALANE (UNII: GW89575KF9)  
    PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76214-013-0150 g in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/01/2011
    Labeler - SKINFOOD CO., LTD. (690324173)
    Registrant - SKINFOOD CO., LTD. (690324173)
    Establishment
    NameAddressID/FEIBusiness Operations
    SKINFOOD CO., LTD.690324173manufacture
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