Label: OBAGI-C RX SYSTEM C-SUNGUARD SPF 30- octinoxate and zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 September 17, 2019

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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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