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

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

NU-DERM SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN (OCTINOXATE AND ZINC OXIDE) LOTION [OMP, INC.]
PDF | XML
NDC 62032-104-10, 62032-104-90
Set ID 04ca07d8-46dc-469c-8482-ffcb3d5bc943
Category HUMAN OTC DRUG LABEL
Packager OMP, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
View All Sections
  • Active ingredients

    Octinoxate 7.5%, Zinc Oxide 10.5%

  • 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

    1,2-hexanediol, caprylyl glycol, ceteareth-20, cetearyl alcohol, chlorphenesin, citric acid, cyclopentasiloxane, dimethicone crosspolymer-3, disodium EDTA, hydrogenated palm glycerides, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, methylisothiazolinone, PEG-10 dimethicone, PEG-40 stearate, pentylene glycol, phenyl trimethicone, polysilicone-11, polysorbate 60, potassium sorbate, sodium benzoate, sodium dihydroxycetyl phosphate, squalane, stearyl alcohol, tetrahexyldecyl ascorbate, tocopheryl acetate, tropolone, ubiquinone, water, xanthan gum

  • 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

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

  • PRINCIPAL DISPLAY PANEL - 85 g Tube Label

    OBAGI
    NU-DERM    ®

    Sun Shield

    MATTE

    Broad
    Spectrum
    SPF 50

    Sunscreen
    Lotion
    PA+++

    Net wt. 3 oz. (85 g.)

    PRINCIPAL DISPLAY PANEL - 85 g Tube Label
  • INGREDIENTS AND APPEARANCE
    NU-DERM SUN SHIELD BROAD SPECTRUM SPF 50   MATTE SUNSCREEN
    octinoxate and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE105 mg  in 1 g
    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)  
    SODIUM DIHYDROXYCETYL PHOSPHATE (UNII: YWI33EV595)  
    HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    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)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    SQUALANE (UNII: GW89575KF9)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-104-9085 g in 1 TUBE
    2NDC:62032-104-1028 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/07/2012
    Labeler - OMP, Inc. (790553353)
    Establishment
    NameAddressID/FEIBusiness Operations
    MILBAR LABORATORIES195556790MANUFACTURE(62032-104)
View All Sections

Related Drugs

Search DailyMed Drugs