OBAGI-C RX SYSTEM C-SUNGUARD SPF 30 (OCTINOXATE AND ZINC OXIDE) CREAM [OMP, INC.]

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OBAGI-C RX SYSTEM C-SUNGUARD SPF 30 (OCTINOXATE AND ZINC OXIDE) CREAM [OMP, INC.]
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NDC 62032-107-90
Set ID 7b4aa8b4-124c-4e26-9a0a-d200867c3d11
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 ingredients

    Octinoxate, 7.5%, Zinc oxide, 9%

  • Purpose

    Sunscreens

  • Uses

    •
    Helps prevent sunburn.
    •
    Higher SPF gives more sunburn protection.
  • 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 the reach of children

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

  • Directions

    •
    Apply generously and evenly 15 minutes before sun exposure.
    •
    Children under six months of age: ask a doctor.
    •
    Reapply as needed or after towel drying, swimming or perspiring.
  • Other information

    •
    Store at controlled room temperature: 15°-30°C (59°-86°F).
    •
    High sun protection product.
    •
    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

    butylparaben, cetearyl alcohol, citric acid, C13-14 isoparaffin, diethanolamine cetyl phosphate, disodium edetate, ethylparaben, isobutylparaben, isopropyl palmitate, laureth-7, methylparaben, octyl stearate, phenoxyethanol, polyacrylamide, polyether-1, polysorbate 60, propylparaben, purified water, sodium hydroxide, triethoxycaprylysilane.

  • SPL UNCLASSIFIED SECTION

    Dist. by OMP, Inc. Long Beach, CA 90802

  • PRINCIPAL DISPLAY PANEL - 90 mL Bottle Carton

    OBAGI-C™
    RX SYSTEM

    RECOMMENDED
    SKIN
    CANCER
    FOUNDATION
    RECOMMENDED AS AN
    EFFECTIVE UV SUNSCREEN

    C-SUNGUARD
    SPF 30

    BROAD-SPECTRUM
    UVA / UVB SUNSCREEN

    AM

    3 FL. OZ. (90 mL)

    Principal Display Panel - 90 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    OBAGI-C RX SYSTEM C-SUNGUARD  SPF 30
    octinoxate and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-107
    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:62032-107-901 in 1 CARTON01/01/2002
    190 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 - OMP, Inc. (790553353)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss-American CDMO, LLC080170933MANUFACTURE(62032-107)
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