NU-DERM HEALTHY SKIN PROTECTION SPF 35 (OCTINOXATE AND ZINC OXIDE) CREAM [OMP, INC.]

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  • NU-DERM HEALTHY SKIN PROTECTION SPF 35 (OCTINOXATE AND ZINC OXIDE) CREAM [OMP, INC.]

NU-DERM HEALTHY SKIN PROTECTION SPF 35 (OCTINOXATE AND ZINC OXIDE) CREAM [OMP, INC.]
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NDC 62032-200-90
Set ID cfb6a918-1403-4cf2-86d8-d66dd764bb6c
Category HUMAN OTC DRUG LABEL
Packager OBAGI COSMECEUTICAL LLC
Generic Name
Product Class
Product Number
Application Number PART352
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Octinoxate 7.5%Sunscreen
    Zinc Oxide 9%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
    • 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: Ask a doctor
  • Other information

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

    butylparaben, cetearyl alcohol, citric acid, C13-14 isoparaffin, DEA-cetyl phosphate, disodium EDTA, ethylhexyl stearate, ethylparaben, isobutylparaben, isopropyl palmitate, laureth-7, methylparaben, phenoxyethanol, polyacrylamide, polyether-1, polysorbate 60, propylparaben, sodium hydroxide, triethoxycaprylylsilane, water (aqua)

  • Questions or comments?

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

  • SPL UNCLASSIFIED SECTION

    Distributed by Obagi Cosmeceuticals LLC, Long Beach, CA 90806

  • PRINCIPAL DISPLAY PANEL - 85 g Bottle Label

    RECOMMENDED
    SKIN
    CANCER
    FOUNDATION
    DAILY USE

    The Skin Cancer Foundation
    recommends this Product as an
    effective UVA/UVB sunscreen

    OBAGI
    NU-DERM®

    AM
    HEALTHY SKIN
    PROTECTION

    BROAD SPECTRUM SPF 35

    6
    SUNSCREEN LOTION

    Net wt. 3 oz. (85 g)

    PRINCIPAL DISPLAY PANEL - 85 g Bottle Label
  • INGREDIENTS AND APPEARANCE
    NU-DERM HEALTHY SKIN PROTECTION  SPF 35
    octinoxate and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE90 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-200-9090 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/200203/31/2020
    2NDC:62032-200-011 in 1 CARTON04/01/2020
    285 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/01/2002
    Labeler - OBAGI COSMECEUTICAL LLC (790553353)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss-American CDMO, LLC080170933MANUFACTURE(62032-200)
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