Label: NU-DERM PHYSICAL UV BLOCK SPF 32- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 23, 2011

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  • ACTIVE INGREDIENTS

    Zinc oxide 18.5%.

  • WARNINGS

    FOR EXTERNAL USE ONLY. Avoid contact with eyes. If this occurs, rinse with water.

  • STOP USE

    Stop use and contact a doctor if rash or irritation develops.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DIRECTIONS

    Apply liberally to all exposed areas 15 minutes prior to sun exposure and as needed. For children less than 6 months of age, consult a doctor.

  • STORAGE AND HANDLING

    Store at controlled room temperature:
    15°-30°C (59°-86°F)

  • INACTIVE INGREDIENTS

    bees wax, butylene glycol, cetyl dimethicone, cetyl PEG/PPG-10/1 dimethicone, dimethicone, disodium EDTA, glycereth-26, hydrogenated castor oil, isopropyl palmitate, methylparaben, octyl stearate, propylparaben, purified water, sodium chloride, triethoxycaprylylsilane, tocopherol acetate, willowherb extract

  • SPL UNCLASSIFIED SECTION

    Dist. by OMP Inc. Long Beach, CA 90802

  • PRINCIPAL DISPLAY PANEL - 57g Bottle Label

    OBAGI
    NU-DERM®

    AM
    PHYSICAL
    UV BLOCK
    SPF 32

    6

    BROAD SPECTRUM UVA/UVB
    PHYSICAL SUNBLOCK

    18.5% ZINC OXIDE

    NET WT. 2 OZ. (57g)

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    NU-DERM PHYSICAL UV BLOCK   SPF 32
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-102
    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:62032-102-3657 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/01/2004
    Labeler - OMP, Inc. (790553353)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss-American Products611921669MANUFACTURE(62032-102)
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