RE9 ADVANCED PREPWORK SOFT FOCUS VEIL BROAD SPECTRUM SPF30 SUNSCREEN (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [ARBONNE INTERNATIONAL, LLC]

RE9 ADVANCED PREPWORK SOFT FOCUS VEIL BROAD SPECTRUM SPF30 SUNSCREEN (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [ARBONNE INTERNATIONAL, LLC]
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NDC 42508-205-19
Set ID 6bde34c6-0a62-63e1-e053-2991aa0a635f
Category HUMAN OTC DRUG LABEL
Packager Arbonne International, LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • Drug Facts

  • Active Ingredients

    Titanium Dioxide 2.5%

    Zinc Oxide 7.2%

  • Purpose

    Sunscreen

  • PURPOSE

    •​ helps prevent sunburn

  • Uses

    •​ 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.

  • 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, regulary 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
  • KEEP OUT OF REACH OF CHILDREN

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

  • Other information

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

    water, ethylhexyl palmitate, caprylic/capric triglyceride, cyclopentasiloxane, diisopropyl sebacate, isonoyl isononanoate, polyglyceryl-6 polyricinoleate, polymethylsilsesquioxane, glycerin, argania spinosa kernel oil, polyglyceryl-2 isostearate, tocopheryl acetate, silica, caesalpinia spinosa fruit extract, vaccinium vitis-idaea fruit ectract, kappaphycus alvarezii extract, terminalia ferdinandiana fruit extract, chlorella vulgaris extract, aloe barbadensis leaf juice powder, raspberry seed oil/tocopheryl succinate aminopropanediol esters, olive oil decyl esters, hydrolyzed pea protein, sea salt, squalene, saccharide isomerate, bisabolol, isopropyl myristate, hydrogenated castor oil, xanthan gum, gluconolactone, calcium gluconate, hydrated silica, tocopherol, sodium chloride, magnesium stearate, disteardimonium hectorite, stearalkonium hectorite, propylene carbonate, polyhydroxystearic acid, bentonite, alumina, isopropyl titanium triisostearate, lactic acid, citric acid, phenoxyethanol, potassium sorbate, sodium benzoate, mica, iron oxides (CI 77491, CI 77492, CI 77499), titanium dioxide (CI 77891).

  • Questions or comments?

    1.800.272.6663

    Monday-Friday

    6 a.m.-6 p.m. Pacific time

  • Principle Display Panel

    Secondary PackagingPrimary componentArbonne

    RE9 Advanced

    Soft Focus Veil Broad Spectrum SPF30 Sunscreen

    4681R01_01_REAdvanced_Prepwork_SoftFocusVeil_SPF_ctn_FPO Carton.jpg

    4681R03_01_RE9Advanced_Prepwork_SoftFocusVeil_SPF_comp_FPO_tube.jpg

  • INGREDIENTS AND APPEARANCE
    RE9 ADVANCED PREPWORK SOFT FOCUS VEIL BROAD SPECTRUM SPF30 SUNSCREEN 
    zinc oxide, titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42508-205
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.5 mg  in 100 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7.2 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    CALCIUM GLUCONATE (UNII: SQE6VB453K)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    BENTONITE (UNII: A3N5ZCN45C)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    POLYGLYCERYL-2 MONOISOSTEARATE (UNII: 7B8OE71MQC)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    LINGONBERRY (UNII: 0UNK9RZQ7X)  
    SEA SALT (UNII: 87GE52P74G)  
    SQUALENE (UNII: 7QWM220FJH)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    KAPPAPHYCUS ALVAREZII (UNII: T479H08K2O)  
    KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
    CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    LACTIC ACID, DL- (UNII: 3B8D35Y7S4)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42508-205-191 in 1 CARTON04/19/2018
    13000 mg in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/19/2018
    Labeler - Arbonne International, LLC (021541164)
    Registrant - Autumn Harp, Inc. (064187883)
    Establishment
    NameAddressID/FEIBusiness Operations
    Autumn Harp, Inc.064187883manufacture(42508-205)

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