ISA KNOX 365 SUNSCREEN BROAD SPECTRUM SPF 50 PLUS (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]

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  • ISA KNOX 365 SUNSCREEN BROAD SPECTRUM SPF 50 PLUS (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]

ISA KNOX 365 SUNSCREEN BROAD SPECTRUM SPF 50 PLUS (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]
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NDC 53208-002-00
Set ID 67235082-1943-4a32-9267-799a8eb398d4
Category HUMAN OTC DRUG LABEL
Packager LG Household and Healthcare, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • ISA KNOX 365 SUNSCREEN CREAM BROAD SPECTRUM SPF 50+

  • Active ingredients

    Homosalate 10.0%

    Octisalate 5.0 %

    Avobenzone 3.0%

    Octocrylene 2.6%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn.
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
  • Warnings

    For external use only.

    Do not use on damaged or broken skin.

    When using this product keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if rash occurs.

    Keep out of reach of children.

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply liberally 15 minutes before sun exposure
    • Use a water resistant sunscreen if swimming or sweating
    • Reapply at least every 2 hours
    • Children under 6 months: Ask a doctor
    • Apply to all skin exposed to the sun
  • Other information

    Protect this product from excessive heat and direct sun

  • Inactive ingredients

    • Water, CapryM Methicone, Dipropylene Glycol, Dicaprylyl Carbonate, PEG/PPG-17/6 Copolymer, Methyl Glucose Sesquistearate, SD Alcohol 40-B, Butylene Glycol, Adenosine, Euterpe Oleracea Fruit Extract, Portulaca Oleracea Extract, Morus Alba Bark Extract, Camellia Sinensis Leaf Extract, Dipotassium Glycynbizate, Glyceryl Stearate, PEG-100 Stearate, Potassium Cetyl Phosphate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 80, Panthend, Cetyl Alcohol, Caprylyl Glycol, Hydrogenated Palm Glycerides, Tocopheryl Acetate, PEG-10 Dimethicone, Polyacrylate-15, Polyacrylate-17, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Potassium Hydroxide, Disodium EDTA
  • ISA KNOX 365 SUNSCREEN CREAM BROAD SPECTRUM SPF 50+ 2oz/60ml (53208-002-00)

    ISAKNOXBOXLABEL

    ISAKNOXTUBELABEL

  • INGREDIENTS AND APPEARANCE
    ISA KNOX 365 SUNSCREEN BROAD SPECTRUM SPF 50 PLUS 
    homosalate, octisalate, avobenzone, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE26 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    PEG/PPG-17/6 COPOLYMER (UNII: P5QZM4T259)  
    METHYL GLUCOSE SESQUISTEARATE (UNII: V1YW10H14D)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ADENOSINE (UNII: K72T3FS567)  
    ACAI (UNII: 46AM2VJ0AW)  
    PURSLANE (UNII: M6S840WXG5)  
    MORUS ALBA BARK (UNII: 7O71A48NDP)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PALM KERNEL GLYCERIDES (UNII: W0N2263KJZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53208-002-001 in 1 PACKAGE12/19/2017
    160 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/28/2014
    Labeler - LG Household and Healthcare, Inc. (688276187)
    Establishment
    NameAddressID/FEIBusiness Operations
    Englewood Lab, Inc.080987545manufacture(53208-002)
    Establishment
    NameAddressID/FEIBusiness Operations
    Englewood Lab Korea Co., Ltd.690104005manufacture(53208-002)
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