Label: YAM DOUBLE CARE FLUID SPF17 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 4.0%, AVOBENZONE 1.5%, ENSULIZOLE 1.0%

  • INACTIVE INGREDIENT

    Inactive ingredients:
    WATER, DIISOPROPYL SEBACATE, ALCOHOL DENAT., POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, PHENETHYL BENZOATE, ARBUTIN, 4-METHYLBENZYLIDENE CAMPHOR, DIMETHICONE, 1,2-HEXANEDIOL, SODIUM HYDROXIDE, GLYCERYL STEARATE, PEG-100 STEARATE, CARBOMER, DISODIUM EDTA, DIOSCOREA JAPONICA ROOT EXTRACT, XANTHAN GUM,
    TOCOPHERYL ACETATE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, PHENOXYETHANOL, METHYLPARABEN, BUTYLPARABEN, FRAGRANCE

  • 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: Apply on skin liberally.

  • DOSAGE & ADMINISTRATION

    Dosage and administration: Dispense an ample amount and apply a thin layer onto the skin.

  • PRINCIPAL DISPLAY PANEL

    Image of bottle

  • INGREDIENTS AND APPEARANCE
    YAM DOUBLE CARE FLUID  SPF17 PA PLUS PLUS
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76214-015
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5.6 mL  in 140 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.1 mL  in 140 mL
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE1.4 mL  in 140 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
    PHENETHYL BENZOATE (UNII: 0C143929GK)  
    ARBUTIN (UNII: C5INA23HXF)  
    ENZACAMENE (UNII: 8I3XWY40L9)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DIOSCOREA JAPONICA ROOT (UNII: I43FCF3356)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76214-015-01140 mL in 1 BOTTLE
    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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