MANS BEST FRIEND (OCTINOXATE HOMOSALATE OCTISALATE TITANIUM DIOXIDE) CREAM [JAXON LANE, INC.]

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MANS BEST FRIEND (OCTINOXATE HOMOSALATE OCTISALATE TITANIUM DIOXIDE) CREAM [JAXON LANE, INC.]
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NDC 73072-001-01
Set ID 3eaeecc3-5d66-4f18-b2c0-0cd032352847
Category HUMAN OTC DRUG LABEL
Packager Jaxon Lane, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • Active ingredients

    Octinoxate, Homosalate, Octisalate, titanium dioxide

  • PURPOSE

    Purpose: Sunscreen

  • Inactive Ingredients

    Water, Pentylene Glycol, Methylpropanediol, Caprylyl Methicone, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Isononyl Isononanoate, Ethylhexyl Triazone, Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, Cyclopentasiloxane, Phenoxyethanol, Sodium Acrylate/Sodium   Acryloyldimethyl Taurate Copolymer, Isohexadecane, Aluminium Hydroxide, Stearic Acid, Dimethicone/Vinyl Dimethicone Crosspolymer, Tocopheryl Acetate (Vitamin E), Sorbitan Isostearate, Ammoniumacryloyldimethyl Taurate/VP Copolymer, Allantoin, Polysorbate 80, Butylene Glycol, Sorbitan Oleate, BHT Xanthan Gum, Biosaccharide Gum-4, Sodium Hyaluronate, Moringa Seed Oil, Ethylhexylglycerin, Green Tea Extract, Licorice Root Extract, Panax Ginseng Root Extract, Fragrance

  • 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. Reapply every 2 hours and after swimming. Children under 6 months: Ask a doctor.

    Sun Protection Measures: Sun exposure increases your risc of skin cancer and early skin aging. Use a sunscreen with a minium Broad Spectrum SPF15+ Limit time in the Sun, especially from 10 am - 2pm, wear hats, sunglasses, long-sleeve, clothing and pants. 

  • KEEP OUT OF REACH OF CHILDREN

  • Other Information:

    Protect this product from excessive heat and direct sun.

  • PRINCIPAL DISPLAY PANEL

    Man best friend

  • INGREDIENTS AND APPEARANCE
    MANS BEST FRIEND 
    octinoxate homosalate octisalate titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73072-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE3 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    BEMOTRIZINOL (UNII: PWZ1720CBH)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4)  
    LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EX0F4CZ66H)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    ALLANTOIN (UNII: 344S277G0Z)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73072-001-0160 mL in 1 TUBE; Type 0: Not a Combination Product05/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/01/2019
    Labeler - Jaxon Lane, Inc. (114672469)
    Registrant - Jaxon Lane, Inc. (114672469)
    Establishment
    NameAddressID/FEIBusiness Operations
    EYESOME. Co.,Ltd.557795360manufacture(73072-001)
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