RE9 ADVANCED LIFTING AND CONTOURING BROAD SPECTRUM SPF 15 SUNSCREEN (ZINC OXIDE) CREAM [ARBONNE INTERNATIONAL, LLC]

RE9 ADVANCED LIFTING AND CONTOURING BROAD SPECTRUM SPF 15 SUNSCREEN (ZINC OXIDE) CREAM [ARBONNE INTERNATIONAL, LLC]
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NDC 42508-079-08, 42508-079-11
Set ID 1800d39c-ca3b-484c-9dab-5af30cd25045
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 4.45%

  • 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 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, simmondsia chinensis (jojoba) seed oil, polyglyceryl-3 methylglucose distearate, cetyl alcohol, caprylic/capric triglyceride, cetyl dimethicone, cetyl palmitate, dimethicone, behenyl alcohol, cetearyl alcohol, glyceryl stearate, squalane, isononyl isononanoate, butyrospermum parkii (shea) butter, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, hydroxyethylcellulose, xanthan gum, caprylyl glycol, sodium lauroyl glutamate, stearic acid, polysorbate 60, sorbitan isostearate, olea europaea (olive) fruit oil, hippophae rhamnoides oil, aloe barbadensis leaf juice, osmanthus fragrans flower extract, paeonia albiflora root extract, chondrus crispus extract, laminaria digitata extract, ganoderma lucidum (mushroom) stem extract, serenoa serrulata fruit extract, anthemis nobilis flower extract, cucumis sativus (cucumber) fruit extract, trifolium pratense (clover) flower extract, undaria pinnatifida extract, lithothamnion calcareum extract, tetrahexyldecyl ascorbate, panthenol, tocopheryl acetate, pantolactone, acetyl tetrapeptide-2, vinyl dimethicone/methicone silsesquioxane crosspolymer, micrococcus lysate, biosaccharide gum-1, disodium acetyl glucosamine phosphate, ethylhexylglycerin, citric acid, caprylhydroxamic acid, phytic acid, sodium citrate, sodium phosphate, disodium phosphate, aminomethyl propanediol, propanediol, triethoxycaprylylsilane, chlorphenesin, phenoxyethanol.

  • 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 - 50 g Jar Carton

    ARBONNE®

    RE9 ADVANCED®

    LIFTING AND CONTOURING CREAM
    BROAD SPECTRUM SPF 15 SUNSCREEN

    Net wt. 1.7 oz. / 50 g

    PRINCIPAL DISPLAY PANEL - 50 g Jar Carton
  • INGREDIENTS AND APPEARANCE
    RE9 ADVANCED   LIFTING AND CONTOURING BROAD SPECTRUM SPF 15 SUNSCREEN
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42508-079
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.45 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Aminomethyl Propanediol (UNII: CZ7BU4QZJZ)  
    Chamaemelum Nobile Flower (UNII: O2T154T6OG)  
    Docosanol (UNII: 9G1OE216XY)  
    Biosaccharide Gum-1 (UNII: BB4PU4V09H)  
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    Caprylhydroxamic Acid (UNII: UPY805K99W)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Cetyl Dimethicone 25 (UNII: U4AS1BW4ZB)  
    Cetyl Palmitate (UNII: 5ZA2S6B08X)  
    Chlorphenesin (UNII: I670DAL4SZ)  
    Chondrus Crispus (UNII: OQS23HUA1X)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Cucumber (UNII: YY7C30VXJT)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Ganoderma Lucidum Stem (UNII: U8PA41532G)  
    Glycerin (UNII: PDC6A3C0OX)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Glyoxal (UNII: 50NP6JJ975)  
    Hippophae Rhamnoides Seed Oil (UNII: T53SBG6741)  
    Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.S At 1.5%) (UNII: 86FQE96TZ4)  
    Isononyl Isononanoate (UNII: S4V5BS6GCX)  
    Laminaria Digitata (UNII: 15E7C67EE8)  
    Olive Oil (UNII: 6UYK2W1W1E)  
    Osmanthus Fragrans Flower (UNII: 4VA0BH57HU)  
    Paeonia Lactiflora Root (UNII: 3Z3866YW6P)  
    Dexpanthenol (UNII: 1O6C93RI7Z)  
    Pantolactone, (R)- (UNII: J288D7O0JS)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Fytic Acid (UNII: 7IGF0S7R8I)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Propanediol (UNII: 5965N8W85T)  
    Saw Palmetto (UNII: J7WWH9M8QS)  
    Jojoba Oil (UNII: 724GKU717M)  
    Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR)  
    Sodium Lauroyl Glutamate (UNII: NCX1UU2D33)  
    Sorbitan Isostearate (UNII: 01S2G2C1E4)  
    Squalane (UNII: GW89575KF9)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Trifolium Pratense Flower (UNII: 4JS0838828)  
    Undaria Pinnatifida (UNII: ICV1OK7M1S)  
    Water (UNII: 059QF0KO0R)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (UNII: W19EIO0DBE)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)  
    ACETYL TETRAPEPTIDE-2 (UNII: M24S4WZS8J)  
    VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
    DISODIUM ACETYL GLUCOSAMINE PHOSPHATE (UNII: SC89MF712W)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42508-079-081 in 1 CARTON05/10/2018
    150 g in 1 JAR; Type 0: Not a Combination Product
    2NDC:42508-079-113 g in 1 TUBE; Type 0: Not a Combination Product09/01/201511/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35209/01/2015
    Labeler - Arbonne International, LLC (021541164)

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