CACTUS WHITENING SUN SPF 34 PA PLUS PLUS FOR MEN (OCTINOXATE) LOTION [SKINFOOD CO., LTD.]

CACTUS WHITENING SUN SPF 34 PA PLUS PLUS FOR MEN (OCTINOXATE) LOTION [SKINFOOD CO., LTD.]
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NDC 76214-032-01
Set ID fa16d89e-9fa0-482d-8185-52bb8b33038d
Category HUMAN OTC DRUG LABEL
Packager SKINFOOD CO., LTD.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active ingredients: OCTINOXATE 7%, OCTISALATE 5%, TITANIUM DIOXIDE 0.93%

  • INACTIVE INGREDIENT

    Inactive ingredients:
    WATER, ISOAMYL p-METHOXYCINNAMATE, BUTYLENE GLYCOL, PROPYLENE GLYCOL, ARBUTIN, CETEARETH-6 OLIVATE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, C14-22 ALCOHOLS, CYCLOPENTASILOXANE, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, SORBITAN STEARATE, C12-20 ALKYL GLUCOSIDE, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT, ALOE BARBADENSIS LEAF EXTRACT, CEREUS GRANDIFLORUS (CACTUS) FLOWER EXTRACT, ISOHEXADECANE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER, POLYSORBATE 80, POTASSIUM CETYL PHOSPHATE, ALUMINUM HYDROXIDE, STEARIC ACID, BHT, TOCOPHERYL ACETATE, DISODIUM EDTA, METHYLPARABEN, PROPYLPARABEN, PHENOXYETHANOL, FRAGRANCE, SILICA

  • 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:
    Use at the end of your daily skincare regimen.
    Apply liberally onto face and body before sun exposure avoiding the eye area.

  • DOSAGE & ADMINISTRATION

    Dosage and administration:
    For best results, apply at least 15 to 20 minutes before sun exposure.
    Reapply frequently while out in the sun.

  • PRINCIPAL DISPLAY PANEL

    Image of bottle

  • INGREDIENTS AND APPEARANCE
    CACTUS WHITENING SUN  SPF 34 PA PLUS PLUS FOR MEN
    octinoxate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76214-032
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4.9 mL  in 70 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3.5 mL  in 70 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE0.65 mL  in 70 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ARBUTIN (UNII: C5INA23HXF)  
    C14-22 ALCOHOLS (UNII: B1K89384RJ)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CUCUMBER (UNII: YY7C30VXJT)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76214-032-0170 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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