Label: OBAGI-C RX SYSTEM C-EXFOLIATING DAY WITH VITAMIN C- octisalate, octinoxate, and oxybenzone lotion

  • 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 January 2, 2012

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  • DIRECTIONS

    Apply to the face and neck in the morning after Obagi-C Rx System C-Clarifying Serum and before C-SunGuard SPF 30. Massage in gently.

  • WARNINGS

    FOR EXTERNAL USE ONLY.

    Avoid contact with eyes. If contact occurs, rinse with water to remove.

    Stop use and consult a physician if rash or irritation develops.

    Keep out of reach of children.

  • ACTIVE INGREDIENTS

    Octinoxate 7.50%, Octisalate 5.00%, Oxybenzone 4.00%

  • INACTIVE INGREDIENTS

    Arginine, Ascorbyl Glucoside (Vitamin C), Bisabolol, Butylparaben, Caprylic/Capric Triglyceride, Ceteareth-20, Cetearyl Alcohol, Dimethicone, Ethylparaben, Fragrance, Glycerin, Glyceryl Stearate, Glycolic Acid, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isobutylparaben, Methylparaben, PEG/PPG-10/2 Ricinoleate, PEG-100 Stearate, PEG-8 Dimethicone, Phenoxyethanol, Polysorbate 60, Propylparaben, Purified Water, Sodium Hyaluronate (Hyaluronic Acid), Sodium Hydroxide, Squalane, Steareth-2, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E)

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 57 mL Carton

    OBAGI-C™
    RX SYSTEM

    C-EXFOLIATING
    DAY LOTION
    SPF 12
    WITH VITAMIN C

    AM

    2 FL. OZ. (57 mL)

    Principal Display Panel - 57 mL Carton
  • INGREDIENTS AND APPEARANCE
    OBAGI-C RX SYSTEM C-EXFOLIATING DAY  WITH VITAMIN C
    octisalate, octinoxate, and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-108
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    STEARETH-2 (UNII: V56DFE46J5)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ARGININE (UNII: 94ZLA3W45F)  
    WATER (UNII: 059QF0KO0R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    SQUALANE (UNII: GW89575KF9)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    PEG-8 RICINOLEATE (UNII: DM36F4D2OU)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-108-361 in 1 CARTON
    157 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/01/2004
    Labeler - OMP, INC. (790553353)
    Establishment
    NameAddressID/FEIBusiness Operations
    PURETEK CORPORATION785961046MANUFACTURE(62032-108) , LABEL(62032-108) , PACK(62032-108)