TAHITIAN NONI SUNSCREEN SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TAHITIAN NONI INTERNATIONAL]

TAHITIAN NONI SUNSCREEN SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TAHITIAN NONI INTERNATIONAL]
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NDC 14743-536-01, 14743-536-02
Set ID fff721da-5159-4ff2-b683-50d2889b2c61
Category HUMAN OTC DRUG LABEL
Packager Tahitian Noni International
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredients           purpose

    Avobenzone 2%            Sunscreen

    Homosalate 6.5%         Sunscreen

    Octinoxate 7%              Sunscreen  

    Octisalate 5%                Sunscreen

    Oxybenzone 3%            Sunscreen

    Use   helps prevent sunburn

    Keep out of reach of children

    Stop use and ask a doctor if

    -rash or irritation develops and lasts

    Warnings

    For External Use only

    When using this product
    Keep out of eyes. If contact occurs, rinse thoroughly with water
    .
    If swallowed, get medical help or contact a poison control center right away.



    Directions:
    Apply liberally before sun exposure
    Reapply as needed or after towel drying, swimming, or sweating
    Ask a doctor before using on children under 6 months of age


    Inactive Ingredients: Water (Aqua), Morinda citrifolia (Noni) fruit juice, Glyceryl Stearate SE, C12-15 Alkyl Benzoate, Glycerin, Cetearyl Alcohol, Dimethicone, Ceteareth-20, Morinda citrifolia (Noni) Seed Oil, Prunus Amygdalus dulcis (sweet almond) Oil, Elaeis guinesssis (palm) Oil, Butyrospermum parkii (Shea Butter), Vitis vinifera (grape) seed extract, cocos nucifera oil, Gardenia tahitensis (Tiare) flower, Ascorbyl palmitate, retinyl palmitate Carbomer,potassium sorbate, disodium EDTA, Sodium Hydroxide, phenoxy ethanol, caprylyl glycol, tocopheryl acetate, Fragrance (parfum).





    image of back label


  • PRINCIPAL DISPLAY PANEL

    Tahitian Noni

    Sunscreen Lotion
    SPF 30

    200 ml 6.76 fl.oz.




    image of front label

  • INGREDIENTS AND APPEARANCE
    TAHITIAN NONI  SUNSCREEN SPF 30
    avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14743-536
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.0 mL  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE6.5 mL  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.0 mL  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.0 mL  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3.0 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MORINDA CITRIFOLIA FRUIT (UNII: 7829X3G2X5)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MORINDA CITRIFOLIA SEED OIL (UNII: 84J6H9QZUA)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14743-536-021 in 1 BOX
    1NDC:14743-536-01200 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/28/2010
    Labeler - Tahitian Noni International (609927905)
    Registrant - Wasatch Product Development (962452533)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wasatch Product Development962452533manufacture

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