RE9 ADVANCED FOR MEN ANTI-AGING SKINCARE LINE (ZINC OXIDE) KIT [ARBONNE INTERNATIONAL, LLC]

RE9 ADVANCED FOR MEN ANTI-AGING SKINCARE LINE (ZINC OXIDE) KIT [ARBONNE INTERNATIONAL, LLC]
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NDC 42508-024-00
Set ID 702633f4-dfb2-4aba-a699-03f75f20a360
Category HUMAN OTC DRUG LABEL
Packager Arbonne International, LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Zinc Oxide 4.95%

  • 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 swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    For sunscreen use:

    • apply liberally and evenly 15 minutes before sun exposure
    • reapply at least every 2 hours
    • use a water-resistant sunscreen if swimming or sweating
    • Sun Protection 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 value 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
    • children under 6 months of age: ask a doctor
  • Other information

    • protect the product in this container from excessive heat and direct sun
  • Inactive ingredients

    water, C12-15 alkyl benzoate, glycerin, isononyl isononanoate, saccharide isomerate, steareth-21, squalane, ammonium acryloyldimethyltaurate/VP copolymer, caprylic/capric triglyceride, dimethicone, steareth-2, aloe barbadensis leaf juice, hydrolyzed ceratonia siliqua seed extract, laminaria digitata extract, chamomilla recutita (matricaria) flower extract, sophora japonica flower extract, tripleurospermum maritimum extract, malachite extract, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, dehydroxanthan gum, tetrahexyldecyl ascorbate, dipotassium glycyrrhizate, menthol, adenosine, sodium hyaluronate, polyglyceryl-3 laurate, sorbitan oleate, sorbitan isostearate, myristic acid, palmitic acid, stearic acid, triethoxycaprylylsilane, polysorbate 60, propanediol, trisodium ethylenediamine disuccinate, sodium citrate, citric acid, caprylhydroxamic acid, caprylyl glycol, phenoxyethanol, chlorphenesin, sodium benzoate, potassium sorbate, sorbic acid.

  • Questions or comments?

    1.800.272.6663
    Monday–Friday 6 a.m.–6 p.m. Pacific time

  • SPL UNCLASSIFIED SECTION

    Distributed by
    Arbonne International, LLC
    9400 Jeronimo Road
    Irvine, CA 92618 USA

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    ARBONNE®
    pure safe beneficial

    RE9 ADVANCED®
    FOR MEN

    Anti-Aging Skincare Line

    3 x 0.1 fl. oz./3 ml

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    RE9 ADVANCED FOR MEN ANTI-AGING SKINCARE LINE 
    zinc oxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42508-024
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42508-024-001 in 1 CARTON04/14/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 3 mL
    Part 21 TUBE 3 mL
    Part 31 TUBE 3 g
    Part 1 of 3
    RE9 ADVANCED FOR MEN   ANTI-AGING MOISTURIZER BROAD SPECTRUM SPF 15 SUNSCREEN
    zinc oxide lotion
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide49.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    Glycerin (UNII: PDC6A3C0OX)  
    Isononyl Isononanoate (UNII: S4V5BS6GCX)  
    Saccharide Isomerate (UNII: W8K377W98I)  
    Steareth-21 (UNII: 53J3F32P58)  
    Squalane (UNII: GW89575KF9)  
    Ammonium Acryloyldimethyltaurate/VP Copolymer (UNII: W59H9296ZG)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Steareth-2 (UNII: V56DFE46J5)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)  
    Sorbitan Monooleate (UNII: 06XEA2VD56)  
    Propanediol (UNII: 5965N8W85T)  
    Chlorphenesin (UNII: I670DAL4SZ)  
    Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 MPA.S at 1.5%) (UNII: 86FQE96TZ4)  
    Palmitic Acid (UNII: 2V16EO95H1)  
    Dehydroxanthan Gum (UNII: 63ZP7I1BQO)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Trisodium Ethylenediamine Disuccinate (UNII: YA22H34H9Q)  
    Caprylhydroxamic Acid (UNII: UPY805K99W)  
    Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)  
    Menthol, Unspecified Form (UNII: L7T10EIP3A)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR)  
    Adenosine (UNII: K72T3FS567)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Sorbitan Isostearate (UNII: 01S2G2C1E4)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Laminaria Digitata (UNII: 15E7C67EE8)  
    Myristic Acid (UNII: 0I3V7S25AW)  
    Chamomile (UNII: FGL3685T2X)  
    Styphnolobium Japonicum Flower (UNII: 644C3CSB6E)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Polyglyceryl-3 Laurate (UNII: Y9ZSR39D0E)  
    Sorbic Acid (UNII: X045WJ989B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    13 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 finalpart35204/14/2016
    Part 2 of 3
    RE9 ADVANCED FOR MEN   MICRO-EXFOLIATING CLEANSER
    cleansing (cold creams, cleansing lotions, liquids, and pads)
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWater (UNII: 059QF0KO0R)  
    INGRSodium Cocoyl Isethionate (UNII: 518XTE8493)  
    INGRCetyl Alcohol (UNII: 936JST6JCN)  
    INGRGlycerin (UNII: PDC6A3C0OX)  
    INGRGlyceryl Monostearate (UNII: 230OU9XXE4)  
    INGRSodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)  
    INGRPalmitic Acid (UNII: 2V16EO95H1)  
    INGRStearic Acid (UNII: 4ELV7Z65AP)  
    INGRCellulose, Microcrystalline (UNII: OP1R32D61U)  
    INGRCocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    INGRLauryl Laurate (UNII: GPW77G0937)  
    INGRDecyl Glucoside (UNII: Z17H97EA6Y)  
    INGRTitanium Dioxide (UNII: 15FIX9V2JP)  
    INGRCoconut Acid (UNII: 40U37V505D)  
    INGRMyristic Acid (UNII: 0I3V7S25AW)  
    INGRSodium Isethionate (UNII: 3R36J71C17)  
    INGRCaprylyl Glycol (UNII: 00YIU5438U)  
    INGRDiheptyl Succinate (UNII: 057N7SS26Y)  
    INGRDimethicone (UNII: 92RU3N3Y1O)  
    INGRHYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    INGRLaminaria Digitata (UNII: 15E7C67EE8)  
    INGRTetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)  
    INGR.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    INGRPanthenol Triacetate, (+)- (UNII: 1206E8961B)  
    INGRSodium Chloride (UNII: 451W47IQ8X)  
    INGRSodium Sulfate (UNII: 0YPR65R21J)  
    INGRCaprylhydroxamic Acid (UNII: UPY805K99W)  
    INGRTrisodium Ethylenediamine Disuccinate (UNII: YA22H34H9Q)  
    INGRSodium Hydroxide (UNII: 55X04QC32I)  
    INGRSodium Carbonate (UNII: 45P3261C7T)  
    INGRPhenoxyethanol (UNII: HIE492ZZ3T)  
    INGRSorbic Acid (UNII: X045WJ989B)  
    INGRUltramarine Blue (UNII: I39WR998BI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    13 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    COSMETIC04/14/2016
    Part 3 of 3
    RE9 ADVANCED FOR MEN   EYE REPAIR CREAM
    eye lotion
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWater (UNII: 059QF0KO0R)  
    INGRMedium-Chain Triglycerides (UNII: C9H2L21V7U)  
    INGRCetearyl Olivate (UNII: 58B69Q84JO)  
    INGRGlycerin (UNII: PDC6A3C0OX)  
    INGRCoco-Caprylate (UNII: 4828G836N6)  
    INGRHelianthus Annuus Seed Wax (UNII: 42DG15CHXV)  
    INGRSorbitan Olivate (UNII: MDL271E3GR)  
    INGRCaprylyl Glycol (UNII: 00YIU5438U)  
    INGRGlyceryl Stearate SE (UNII: FCZ5MH785I)  
    INGRCetostearyl Alcohol (UNII: 2DMT128M1S)  
    INGRCARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    INGRSorbitan Monopalmitate (UNII: 77K6Z421KU)  
    INGRSorbitan Monooleate (UNII: 06XEA2VD56)  
    INGRLaminaria Digitata (UNII: 15E7C67EE8)  
    INGRStyphnolobium Japonicum Flower (UNII: 644C3CSB6E)  
    INGRAcacia Decurrens Flower Wax (UNII: AU6XZE9IY9)  
    INGRTetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)  
    INGRCetyl Palmitate (UNII: 5ZA2S6B08X)  
    INGRPropyl Gallate (UNII: 8D4SNN7V92)  
    INGRPolyglycerin-3 (UNII: 4A0NCJ6RD6)  
    INGRAdenosine (UNII: K72T3FS567)  
    INGRTocopherol (UNII: R0ZB2556P8)  
    INGRPropanediol (UNII: 5965N8W85T)  
    INGR1,2-Hexanediol (UNII: TR046Y3K1G)  
    INGRSodium Chloride (UNII: 451W47IQ8X)  
    INGRCaprylhydroxamic Acid (UNII: UPY805K99W)  
    INGRTrisodium Ethylenediamine Disuccinate (UNII: YA22H34H9Q)  
    INGRSodium Carbonate (UNII: 45P3261C7T)  
    INGRCitric Acid Monohydrate (UNII: 2968PHW8QP)  
    INGRSodium Hydroxide (UNII: 55X04QC32I)  
    INGRPhenoxyethanol (UNII: HIE492ZZ3T)  
    INGRBenzyl Alcohol (UNII: LKG8494WBH)  
    INGRDehydroacetic Acid (UNII: 2KAG279R6R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    13 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    COSMETIC04/14/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/14/2016
    Labeler - Arbonne International, LLC (021541164)

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