Label: ARBONNE AGEWELL MOISTURE RESTORING BROAD SPECTRUM SPF 15 SUNSCREEN- zinc oxide cream

  • NDC Code(s): 42508-820-08
  • Packager: Arbonne International, LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 12, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Zinc oxide 4.9%

  • 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 useon damaged or broken skin

    When using this productkeep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor ifrash 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
    • children under 6 months of age: Ask a doctor
    • 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
  • Other information

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

    water, C12-15 alkyl benzoate, glycerin, isononyl isononanoate, steareth-21, caprylic/capric triglyceride, squalane, dimethicone, sodium acryloyldimethyltaurate/VP crosspolymer, sorbitan oleate, steareth-2, aloe barbadensis leaf juice, citrus aurantium dulcis (orange) callus culture extract, cucumis sativus (cucumber) fruit extract, laminaria digitata extract, lavandula stoechas extract, pyrus malus (apple) fruit extract, nasturtium officinale extract, trifolium pratense (clover) flower extract, hippophae rhamnoides oil, olea europaea (olive) fruit oil, sodium hyaluronate, tetrahexyldecyl ascorbate, palmitoyl tripeptide-38, polyglyceryl-3 laurate, gluconolactone, xanthan gum, calcium gluconate, magnesium ascorbyl phosphate, tocopherol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, dehydroxanthan gum, triethoxycaprylylsilane, polysorbate 60, sorbitan isostearate, sodium citrate, caprylhydroxamic acid, phytic acid, hydroxypropyl cyclodextrin, aminomethyl propanediol, citric acid, phenoxyethanol, chlorphenesin, potassium sorbate, sodium benzoate.

  • Questions or comments?

    1-800-272-6663Monday–Friday 6 a.m.–6 p.m. PST

  • SPL UNCLASSIFIED SECTION

    Distributed by Arbonne International, LLC • Greenwood, IN 46143 USA

  • PRINCIPAL DISPLAY PANEL - 50 g Jar Carton

    AgeWell

    100% VEGAN – CRUELTY-FREE

    MOISTURE RESTORING CREAM
    WITH BROAD SPECTRUM
    SPF 15 SUNSCREEN

    All Skin Types

    Net wt. 1.7 oz. / 50 g

    AgeWell Moisture Restoring Cream SPF 15 Label

  • INGREDIENTS AND APPEARANCE
    ARBONNE AGEWELL MOISTURE RESTORING BROAD SPECTRUM SPF 15 SUNSCREEN 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42508-820
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE49 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    STEARETH-21 (UNII: 53J3F32P58)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SQUALANE (UNII: GW89575KF9)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    STEARETH-2 (UNII: V56DFE46J5)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CUCUMBER (UNII: YY7C30VXJT)  
    LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
    LAVANDULA STOECHAS FLOWERING TOP (UNII: 70759G2U6A)  
    APPLE (UNII: B423VGH5S9)  
    NASTURTIUM OFFICINALE (UNII: YH89GMV676)  
    TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)  
    HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  
    POLYGLYCERYL-3 LAURATE (UNII: Y9ZSR39D0E)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CALCIUM GLUCONATE (UNII: SQE6VB453K)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    FYTIC ACID (UNII: 7IGF0S7R8I)  
    HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK)  
    AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42508-820-081 in 1 CARTON05/13/202011/06/2026
    150 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/13/202011/06/2026
    Labeler - Arbonne International, LLC (961643454)
    Establishment
    NameAddressID/FEIBusiness Operations
    Levlad, LLC076245109manufacture(42508-820) , label(42508-820) , pack(42508-820)