NU SKIN TRI-PHASIC WHITE SYSTEM (AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [NSE PRODUCTS, INC.]

NU SKIN TRI-PHASIC WHITE SYSTEM (AVOBENZONE, OCTINOXATE, AND OCTISALATE) KIT [NSE PRODUCTS, INC.]
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NDC 62839-0273-1, 62839-2734-1
Set ID 01329d7c-0695-47a2-9cb7-251b73fc844f
Category HUMAN OTC DRUG LABEL
Packager NSE Products, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    Nu Skin® Tri-Phasic White® Day Milk Lotion Broad Spectrum SPF 15

    Drug Facts

  • Active Ingredient

    Avobenzone (2.4%), Octinoxate (7.4%), Octisalate (3.0%)

  • Purpose

    Sunscreen

  • Use

    • Helps prevent sunburn. Higher SPF gives more sunburn protection.
    • 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.

    • Stop use and ask a doctor if rash occurs.

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

    • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • Use in the morning after applying Tri-Phasic White® Essence. Apply liberally to face and neck.
    • Sunprotection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including:
      • Limit time in the sun, especially from 10 a.m.–2 p.m.
      • Wear long-sleeved shirts, pants, hats, and sunglasses.
    • 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.
  • Inactive Ingredients

    Water (Aqua), Cyclomethicone, Butylene Glycol, Bis-PEG/PPG-16/16 PEG/PPG-16/16 Dimethicone, Octyldodecyl Neopentanoate, Glycerin, Squalane, Hexapeptide-2, Caprylic/ Capric Triglyceride, Phenyl Trimethicone, Tocopheryl Acetate, Allantoin, Phospholipids, Xanthan Gum, Dimethiconol, Dextran, Polyphosphorylcholine Glycol Acrylate, Polysorbate 80, PEG-8, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polysorbate 60, Aminomethyl Propanol, Disodium EDTA, Fragrance (Parfum), Phenoxyethanol, Chlorphenesin, Methylparaben, Benzoic Acid.

  • Other Information

    • Protect this product from excessive heat and direct sun.
  • Questions?

    1-888-742-7626

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    NU SKIN

    Tri-Phasic White®

    SYSTEM

    Principal Display Panel - Kit Carton
  • INGREDIENTS AND APPEARANCE
    NU SKIN TRI-PHASIC WHITE SYSTEM 
    avobenzone, octinoxate, and octisalate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62839-2734
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62839-2734-11 in 1 CARTON; Type 0: Not a Combination Product04/01/2013
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 75 mL
    Part 21 TUBE 100 mL
    Part 31 BOTTLE, PLASTIC 125 mL
    Part 41 BOTTLE, PUMP 30 mL
    Part 51 JAR 30 mL
    Part 1 of 5
    NU SKIN TRI-PHASIC WHITE DAY MILK BROAD SPECTRUM SPF 15 
    avobenzone, octinoxate, and octisalate lotion
    Product Information
    Item Code (Source)NDC:62839-0273
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone24 mg  in 1 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate74 mg  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Cyclomethicone (UNII: NMQ347994Z)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Octyldodecyl Neopentanoate (UNII: X8725R883T)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    Squalane (UNII: GW89575KF9)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Chlorphenesin (UNII: I670DAL4SZ)  
    Glycerin (UNII: PDC6A3C0OX)  
    Allantoin (UNII: 344S277G0Z)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Benzoic Acid (UNII: 8SKN0B0MIM)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Aminomethylpropanol (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62839-0273-175 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35204/01/2013
    Part 2 of 5
    NU SKIN TRI-PHASIC WHITE CLEANSER 
    cleansing (cold creams, cleansing lotions, liquids, and pads) liquid
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWater (UNII: 059QF0KO0R)  
    INGRSodium Cocoyl Isethionate (UNII: 518XTE8493)  
    INGRStearic Acid (UNII: 4ELV7Z65AP)  
    INGRCetostearyl Alcohol (UNII: 2DMT128M1S)  
    INGRDiglycerin (UNII: 3YC120743U)  
    INGRGlycol Stearate (UNII: 0324G66D0E)  
    INGRSafflower Oil (UNII: 65UEH262IS)  
    INGRCreatinine (UNII: AYI8EX34EU)  
    INGRLaureth-4 (UNII: 6HQ855798J)  
    INGRSodium Hydroxide (UNII: 55X04QC32I)  
    INGRMethylparaben (UNII: A2I8C7HI9T)  
    INGREdetate Disodium (UNII: 7FLD91C86K)  
    INGRPropylparaben (UNII: Z8IX2SC1OH)  
    INGR.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    INGRCitric Acid Monohydrate (UNII: 2968PHW8QP)  
    INGRPinus Tabuliformis Bark (UNII: 3G75L8C3RU)  
    INGRMethylchloroisothiazolinone (UNII: DEL7T5QRPN)  
    INGRMethylisothiazolinone (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1100 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic04/01/2013
    Part 3 of 5
    NU SKIN TRI-PHASIC WHITE TONER 
    other skin care preparations liquid
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWater (UNII: 059QF0KO0R)  
    INGRHamamelis Virginiana Top Water (UNII: NT00Y05A2V)  
    INGRButylene Glycol (UNII: 3XUS85K0RA)  
    INGRDeanol (UNII: 2N6K9DRA24)  
    INGRCitric Acid Monohydrate (UNII: 2968PHW8QP)  
    INGRPolysorbate 20 (UNII: 7T1F30V5YH)  
    INGRUrea (UNII: 8W8T17847W)  
    INGRGlycerin (UNII: PDC6A3C0OX)  
    INGRChlorphenesin (UNII: I670DAL4SZ)  
    INGRMethylparaben (UNII: A2I8C7HI9T)  
    INGRGlucosamine Hydrochloride (UNII: 750W5330FY)  
    INGRCarnosine (UNII: 8HO6PVN24W)  
    INGRYeast, Unspecified (UNII: 3NY3SM6B8U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic04/01/2013
    Part 4 of 5
    NU SKIN TRI-PHASIC WHITE ESSENCE 
    other skin care preparations liquid
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWater (UNII: 059QF0KO0R)  
    INGRDimethicone (UNII: 92RU3N3Y1O)  
    INGRButylene Glycol (UNII: 3XUS85K0RA)  
    INGRDiethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B)  
    INGRSqualane (UNII: GW89575KF9)  
    INGRWheat Germ (UNII: YR3G369F5A)  
    INGRLemon Peel (UNII: 72O054U628)  
    INGRChlorphenesin (UNII: I670DAL4SZ)  
    INGRPolysorbate 60 (UNII: CAL22UVI4M)  
    INGRMethylparaben (UNII: A2I8C7HI9T)  
    INGRMentha Piperita Leaf (UNII: A389O33LX6)  
    INGREthylparaben (UNII: 14255EXE39)  
    INGREdetate Disodium (UNII: 7FLD91C86K)  
    INGRPhytosphingosine (UNII: GIN46U9Q2Q)  
    INGRVitis Vinifera Seed (UNII: C34U15ICXA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic04/01/2013
    Part 5 of 5
    NU SKIN TRI-PHASIC WHITE NIGHT 
    night lotion
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWater (UNII: 059QF0KO0R)  
    INGRDimethicone (UNII: 92RU3N3Y1O)  
    INGRButylene Glycol (UNII: 3XUS85K0RA)  
    INGREthylhexyl Palmitate (UNII: 2865993309)  
    INGRMedium-Chain Triglycerides (UNII: C9H2L21V7U)  
    INGRGlycerin (UNII: PDC6A3C0OX)  
    INGRDocosanol (UNII: 9G1OE216XY)  
    INGRCetyl Alcohol (UNII: 936JST6JCN)  
    INGRGlyceryl Monostearate (UNII: 230OU9XXE4)  
    INGRPhenoxyethanol (UNII: HIE492ZZ3T)  
    INGRPanthenol (UNII: WV9CM0O67Z)  
    INGRPEG-75 Stearate (UNII: OT38R0N74H)  
    INGRGlycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)  
    INGRMethylparaben (UNII: A2I8C7HI9T)  
    INGRAminomethylpropanol (UNII: LU49E6626Q)  
    INGRCeteth-20 (UNII: I835H2IHHX)  
    INGRSteareth-20 (UNII: L0Q8IK9E08)  
    INGRChlorphenesin (UNII: I670DAL4SZ)  
    INGRC12-13 Pareth-23 (UNII: J1WW1510L4)  
    INGRTetrahydropiperine (UNII: 8904DO502T)  
    INGREdetate Sodium (UNII: MP1J8420LU)  
    INGRBenzoic Acid (UNII: 8SKN0B0MIM)  
    INGRDiacetyl Boldine (UNII: 37727Z7M0I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic04/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/01/2013
    Labeler - NSE Products, Inc. (803486393)

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