NU-DERM PHYSICAL UV BROAD SPECTRUM SPF 32 (ZINC OXIDE) LOTION [OBAGI COSMECEUTICALS LLC]

NU-DERM PHYSICAL UV BROAD SPECTRUM SPF 32 (ZINC OXIDE) LOTION [OBAGI COSMECEUTICALS LLC]
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NDC 62032-070-18
Set ID 0960cb9d-413e-4eeb-83b8-135b75642f90
Category HUMAN OTC DRUG LABEL
Packager Obagi Cosmeceuticals LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION


    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientPurpose

    Zinc Oxide 18.5%

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

    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
    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
  • Inactive ingredients

    beeswax, butylene glycol, cetyl dimethicone, cetyl PEG/PPG-10/1 dimethicone, dimethicone, disodium EDTA, epilobium angustifolium flower/leaf/stem extract, ethylhexyl stearate, glycereth-26, hydrogenated castor oil, isopropyl palmitate, methylparaben, propylparaben, sodium chloride, tocopherol acetate, triethoxycaprylylsilane, water

  • Other information

    store at controlled room temperature: 15°C-25°C (59°F-77°F)
    protect this product from excessive heat and direct sun
  • Questions or comments?

    1.800.636.7546
    Monday-Friday 9 a.m.-4 p.m. Pacific Time

  • SPL UNCLASSIFIED SECTION

    Obagi Nu-Derm is a registered trademark of OMP, Inc.

    Distributed by OMP, Inc., Long Beach, CA 90806

    ©2012 Obagi Medical Products, Inc. All rights reserved.

    www.obagi.com
    Made in USA

    10701810Z 7018

  • PRINCIPAL DISPLAY PANEL - 57 g Bottle Label

    OBAGI
    NU-DERM®

    AM
    PHYSICAL
    UV
    BROAD SPECTRUM
    SPF 32

    6

    Zinc Oxide 18.5%

    SUNSCREEN LOTION

    Net wt. 2 oz. (57 g)

    Principal Display Panel - 57 g Bottle Label
  • INGREDIENTS AND APPEARANCE
    NU-DERM PHYSICAL UV  BROAD SPECTRUM SPF 32
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-070
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE185 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-070-1857 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2004
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/01/2004
    Labeler - Obagi Cosmeceuticals LLC (790553353)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss- American CDMO, LLC080170933MANUFACTURE(62032-070)

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