NU-DERM SUN SHIELD SPF 50 SUNSCREEN (ZINC OXIDE AND OCTINOXATE) LOTION [OMP, INC.]

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  • NU-DERM SUN SHIELD SPF 50 SUNSCREEN (ZINC OXIDE AND OCTINOXATE) LOTION [OMP, INC.]

NU-DERM SUN SHIELD SPF 50 SUNSCREEN (ZINC OXIDE AND OCTINOXATE) LOTION [OMP, INC.]
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NDC 62032-124-10
Set ID 9e323803-0165-4bca-8b54-5cefe1f4e7b2
Category HUMAN OTC DRUG LABEL
Packager OMP, Inc.
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 10.5%Sunscreen
  • Uses

    • helps prevent sunburn
    • higher SPF provides more sunburn protection
    • provides high protection against sunburn
  • Warnings

    For external use only.

    When using this product

    • keep out of eyes. rinse with water to remove.

    Stop use and ask a doctor if

    • rash or irritation develops and lasts.

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

  • Directions

    • Apply liberally 30 minutes before sun exposure and as needed.
    • Children under 6 months of age: ask a doctor.
    • Reapply as needed or after towel drying, swimming, or perspiring.
  • Other Information

    • Store at controlled room temperature:
      15°C-30° (59°F-86°F).
    • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
  • Inactive Ingredients

    Water, Cyclopentasiloxane, PEG-10 Dimethicone, Pentylene Glycol, Stearyl Alcohol, Phenyl Trimethicone, PEG-40 Stearate, Hydroxyethyl Acrylate/Sodium Acryloydimethyl Taurate Copolymer, Sodium Dihydroxycetyl Phosphate, Citric Acid, Squalane, Ceteareth-20, Polysilicone-11, Dimethicone Crosspolymer-3, Chlorphenesin, Cetearyl Alcohol, Ethoxylated Sorbitan Ester, Xanthan Gum, 1,2-Hexanediol, Caprylyl Glycol, Potassium Sorbate, Sodium Benzoate, Polysorbate 60, Tetrahexyldecyl Ascorbate, Disodium EDTA, Methylisothiazolinone, Hydrogenated Palm Glycerides, Ubiquinone, Tropolone.

  • Questions?

    1.800.636.7546

    Monday–Friday 9:00 AM–4:00 PM Pacific Time

  • SPL UNCLASSIFIED SECTION

    Distributed by OMP, Inc.

  • PRINCIPAL DISPLAY PANEL - 89 mL Tube Carton

    OBAGI®
    MEDICAL

    Nu-Derm®

    Sun Shield
    SPF 50

    Sunscreen Lotion
    High UVA/PA+++
    UVB

    6
    AM

    NON-COMEDOGENIC
    DERMATOLOGIST TESTED

    3 fl. oz. (89 mL)

    Principal Display Panel - 89 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    NU-DERM SUN SHIELD SPF 50 SUNSCREEN 
    zinc oxide and octinoxate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-124
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE105 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    WATER (UNII: 059QF0KO0R)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TROPOLONE (UNII: 7L6DL16P1T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SQUALANE (UNII: GW89575KF9)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-124-101 in 1 CARTON
    189 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/05/2011
    Labeler - OMP, Inc. (790553353)
    Establishment
    NameAddressID/FEIBusiness Operations
    Milbar Laboratories195556790MANUFACTURE(62032-124)
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