Label: OBAGI-C RX SYSTEM NORMAL-OILY SKIN INTERVENTION- hydroquinone, octinoxate and zinc oxide kit

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated August 12, 2013

If you are a consumer or patient please visit this version.

  • C-Cleansing Gel 6 fl. oz. (177 mL.) AM+PM

    A gel-based facial cleanser that clarifies and prepares your skin for absorption of the system's product ingredients. This concentrated cleanser gently removes excess oil, makeup, and other everyday impurities, and rinses clean, leaving your skin feeling fresh and clear.

  • Directions

    Use twice daily, morning and evening. Massage a small amount of cleanser and lukewarm water onto skin, rubbing gently in a circular motion. Rinse completely with lukewarm water and gently pat dry.

  • Warnings

    Avoid getting into eyes. For external use only.

    Keep out of reach of children.

  • Ingredients

    water (aqua), sodium laureth sulfate, sodium lauroyl oat amino acids, cocamidopropyl betaine, aloe barbadensis leaf juice (aloe barbadensis), ascorbic acid, glycerin, medicago sativa (alfalfa) extract, borago officinalis extract, chamomilla recutita (matricaria) flower extract (chamomilla recutita extract), sodium chloride, saponins, xanthan gum, phenoxyethanol, methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben, fragrance (parfum), red 33 (CI 17200), yellow 5 (CI 19140)

  • C-Balancing Toner 6.7 fl. oz. (198 mL.) AM+PM

    Specifically formulated for normal to oily skin, the C-Balancing Toner adjusts your skin's pH balance. As an essential step after cleansing, this alcohol-free, non-drying toner thoroughly removes impurities and dead skin cells to prepare the skin for the next step in your skin care regimen. s.

  • Directions

    Use twice daily, in the morning and evening after cleansing. Pump a small amount (3-4 pumps) onto a cotton pad and gently wipe over entire face. Let air dry. Do not rinse.

  • Warnings

    Avoid getting into eyes. For external use only.

    Keep out of reach of children.

  • Ingredients

    water (aqua), hamamelis virginiana (witch hazel) water, propylene glycol, sodium pca, benzalkonium chloride, aloe barbadensis leaf juice (aloe barbadensis), panthenol, polyquaternium-10, phenoxyethanol, methylparaben

  • C-Clarifying Serum Normal to Oily (Skin Lightening Serum) NDC 62032-122-10 1 fl. oz. (30 mL.) Hydroquinone USP, 4% Rx Only AM

    Antioxidant serum containing Vitamin C and prescription-strength hydroquinone. This patented formulation for normal to oily skin reduces the appearance of dark spots for a lighter, brighter complexion.

  • Indications and usage

    The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

  • Dosage and administration

    Use once daily in the morning. Apply 5-7 drops to the entire face, or as directed by your skin care physician. Massage in gently. If no improvement is seen after three (3) months of treatment, use of this product should be discontinued. Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.

  • Warnings

    Avoid contact with eyes, nose, mouth, or lips. In case of accidental contact, patient should rinse eyes thoroughly with water and contact physician. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity.

  • DESCRIPTION

    Each gram of Obagi-C Rx C-Clarifying Serum Normal to Oily contains:

    Active Ingredient

    Hydroquinone USP, 4% (40 mg/g)

    Inactive Ingredients

    water, propylene glycol, alcohol denat., dipropylene glycol, ascorbic acid, propylene carbonate, sodium lauryl sulfate, fragrance

  • SPL UNCLASSIFIED SECTION

    See enclosed Package Insert for full prescribing information.

    Rx ONLY. FOR EXTERNAL USE ONLY.

  • C-Therapy Night Cream (Skin Lightener) NDC 62032-105-36 Net wt. 2 oz. (57 g.) Hydroquinone USP, 4% Rx Only PM

    A rich moisturizer that works while you sleep to renew and rejuvenate your skin. The C-Therapy Night Cream is uniquely formulated with prescription-strength hydroquinone to gradually diminish the appearance of dark spots and delivers Vitamins C and E during the skin's nightly renewal process.

  • Indications and usage

    The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

  • Dosage and Administration

    Use daily in the evening. Dispense a small amount (approximately 1-2 pea-sized drops) and apply to the entire face. Massage in gently. If no improvement is seen after three (3) months of treatment, use of this product should be discontinued. Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.

  • Warnings

    Avoid contact with eyes, nose, mouth, or lips. In case of accidental contact, patient should rinse eyes thoroughly with water and contact physician. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity.

    Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

  • DESCRIPTION

    Each gram of Obagi-C Rx C-Therapy Night Cream contains:

    Active Ingredient

    Hydroquinone USP, 4% (40 mg/g)

    Inactive Ingredients

    water, glycerin, cetyl alcohol, PPG-2 myristyl ether propionate, sodium lauryl sulfate, TEA-salicylate, lactic acid, phenyl trimethicone, tocopheryl acetate, sodium metabisulfite, ascorbic acid, methylparaben, disodium EDTA, propylparaben, saponins, BHT

  • SPL UNCLASSIFIED SECTION

    See enclosed Package Insert for full prescribing information.

    Rx ONLY. FOR EXTERNAL USE ONLY.

  • SPL UNCLASSIFIED SECTION

    Travel Bag and Patient Instruction Guide

  • Sun Shield Broad Spectrum SPF 50 Matte Net wt. 3 oz. (85 g)

    This sunscreen combines UVB absorption and UVA protection in an elegant matte finish that is non-comedogenic, hypoallergenic, non-acnegenic, and dermatologist tested. Sheer, PABA free, and fragrance free for all skin types.

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Octinoxate 7.5%Sunscreen
    Zinc Oxide 10.5%Sunscreen
  • 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, dimethicone crosspolymer-3, disodium EDTA, glycerin, hydrogenated palm glycerides, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, methylisothiazolinone, PEG-40 stearate, pentylene glycol, phenoxyethanol, phenyl trimethicone, polysilicone-11, polysorbate 60, potassium sorbate, sodium benzoate, sodium dihydroxycetyl phosphate, sodium polyacrylate, squalane, stearyl alcohol, tetrahexyldecyl ascorbate, tropolone, 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

    Store at controlled room temperature 15°C–25°C (59°F–77°F).

    Obagi-C and the Obagi logo are registered trademarks of OMP, Inc.

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

    ©2012 Obagi Medical Products, Inc. All rights reserved.
    obagi.com Made in USA 41502111Z 5021

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    NDC # 62032-523-04

    OBAGI®
    MEDICAL

    OBAGI-C® RX SYSTEM

    NORMAL OILY

    Skin Intervention Kit

    Principal Display Panel - Kit Carton
  • INGREDIENTS AND APPEARANCE
    OBAGI-C RX SYSTEM NORMAL-OILY  SKIN INTERVENTION
    hydroquinone, octinoxate and zinc oxide kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62032-523
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-523-041 in 1 CARTON
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, GLASS 30 mL
    Part 21 BOTTLE, PLASTIC 57 g
    Part 31 TUBE 85 g
    Part 41 BOTTLE, PLASTIC 177 mL
    Part 51 BOTTLE, PLASTIC 198 mL
    Part 1 of 5
    OBAGI C RX SYSTEM C CLARIFYING SERUM 
    hydroquinone liquid
    Product Information
    Item Code (Source)NDC:62032-122
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    ALCOHOL (UNII: 3K9958V90M)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-122-101 in 1 CARTON
    130 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other01/01/2010
    Part 2 of 5
    OBAGI-C RX SYSTEM C-THERAPY   SKIN LIGHTENING WITH VITAMINS C AND E
    hydroquinone cream
    Product Information
    Item Code (Source)NDC:62032-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)  
    TROLAMINE SALICYLATE (UNII: H8O4040BHD)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    WATER (UNII: 059QF0KO0R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-105-3657 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other01/01/2004
    Part 3 of 5
    OBAGI-C RX SYSTEM SUN SHIELD BROAD SPECTRUM SPF 50  MATTE SUNSCREEN
    octinoxate and zinc oxide lotion
    Product Information
    Item Code (Source)NDC:62032-121
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    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)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    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)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-121-9085 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/12/2013
    Part 4 of 5
    OBAGI-C RX SYSTEM C-CLEANSING  WITH VITAMIN C
    cleansing (cold creams, cleansing lotions, liquids, and pads) gel
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRETHYLPARABEN (UNII: 14255EXE39)  
    INGRISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    INGRBUTYLPARABEN (UNII: 3QPI1U3FV8)  
    INGRPROPYLPARABEN (UNII: Z8IX2SC1OH)  
    INGRMETHYLPARABEN (UNII: A2I8C7HI9T)  
    INGRASCORBIC ACID (UNII: PQ6CK8PD0R)  
    INGRSODIUM LAUROYL OAT AMINO ACIDS (UNII: FSW2K9B9N5)  
    INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    INGRSODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
    INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
    INGRALFALFA (UNII: DJO934BRBD)  
    INGRCHAMOMILE (UNII: FGL3685T2X)  
    INGRXANTHAN GUM (UNII: TTV12P4NEE)  
    INGRD&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    INGRFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    ColorORANGEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1177 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic01/01/2004
    Part 5 of 5
    OBAGI-C RX SYSTEM C-BALANCING TONER  FOR NORMAL TO OILY SKIN
    cleansing (cold creams, cleansing lotions, liquids, and pads) liquid
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRMETHYLPARABEN (UNII: A2I8C7HI9T)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRPROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
    INGRHAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
    INGRBENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    INGRPOLYQUATERNIUM-10 (400 MPA.S At 2%) (UNII: HB1401PQFS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1198 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic01/01/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other04/02/2013
    Labeler - OMP, INC. (790553353)
    Establishment
    NameAddressID/FEIBusiness Operations
    PURETEK CORPORATION785961046MANUFACTURE(62032-523) , LABEL(62032-523) , PACK(62032-523)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ei INC.105803274MANUFACTURE(62032-523) , LABEL(62032-523) , PACK(62032-523) , ANALYSIS(62032-523)
    Establishment
    NameAddressID/FEIBusiness Operations
    MILBAR LABORATORIES195556790MANUFACTURE(62032-523)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bay Cities Container Corporation066229618RELABEL(62032-523) , REPACK(62032-523)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss-American Products611921669MANUFACTURE(62032-523)