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OBAGI-C RX SYSTEM SUN SHIELD BROAD SPECTRUM SPF 50 (OMP, Inc.)

Available Formats

Dosage Form Package Information Links
LOTION 85 g in 1 TUBE (62032-121-90) Label Information

Complete OBAGI-C RX SYSTEM SUN SHIELD BROAD SPECTRUM SPF 50 Information

  • SPL UNCLASSIFIED SECTION

    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)


  • SPL UNCLASSIFIED SECTION

    C-Clarifying Serum Normal to Dry (Skin Lightening Serum) NDC 62032-106-10 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 dry 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.

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


  • Active Ingredient

    Hydroquinone USP, 4% (40 mg/g)


  • Inactive Ingredients

    propylene glycol, water, ascorbic acid, propylene carbonate, sodium lauryl sulfate.


  • SPL UNCLASSIFIED SECTION

    See enclosed Package Insert for full prescribing information.

    Rx ONLY. FOR EXTERNAL USE ONLY.


  • SPL UNCLASSIFIED SECTION

    C-Exfoliating Day Lotion Net wt. 2 oz. (57 g.) AM

    A smooth, lightweight moisturizer that not only hydrates, but also gently exfoliates the skin, revealing a brighter, healthier-looking complexion.


  • Directions

    Use once daily in the morning. Squeeze a small amount (approximately 1-2 pea-sized drops) onto your hands. Using your fingertips, apply evenly to the entire face. Massage gently until completely absorbed.


  • Warnings

    Avoid getting into eyes. For external use only.

    Keep out of reach of children.

    Sunburn Alert

    This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.


  • Ingredients

    water (aqua), ethylhexyl palmitate, ethylhexyl stearate, glycolic acid, caprylic/capric triglyceride, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isopropyl palmitate, sodium hyaluronate, squalane, PEG-8 dimethicone, glyceryl stearate, PEG-100 stearate, glycerin, sodium hydroxide, PEG-8 ricinoleate, ascorbyl glucoside, tocopheryl acetate, dimethicone, arginine, cetearyl alcohol, ceteareth-20, steareth-2, bisabolol, tetrasodium EDTA, polysorbate 60, phenoxyethanol, methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben, fragrance (parfum)


  • SPL UNCLASSIFIED SECTION

    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.


  • SPL UNCLASSIFIED SECTION

    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.

    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


  • SPL UNCLASSIFIED SECTION

    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 ingredients Purpose
    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


  • STORAGE AND HANDLING

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


  • SPL UNCLASSIFIED SECTION

    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 41502211Z 5022


  • PRINCIPAL DISPLAY PANEL - Kit Carton

    NDC# 62032-524-04

    OBAGI®
    MEDICAL

    OBAGI-C® RX SYSTEM

    NORMAL DRY
    Skin Intervention Kit

    PRINCIPAL DISPLAY PANEL - Kit Carton

  • INGREDIENTS AND APPEARANCE
    OBAGI-C RX SYSTEM NORMAL-DRY  SKIN INTERVENTION
    hydroquinone, octinoxate and zinc oxide kit
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62032-524
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62032-524-04 1 in 1 CARTON
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 BOTTLE, GLASS 30 mL
    Part 2 1 BOTTLE, PLASTIC 57 g
    Part 3 1 TUBE 85 g
    Part 4 1 BOTTLE, PLASTIC 177 mL
    Part 5 1 BOTTLE, PLASTIC 57 g
    Part 1 of 5
    OBAGI-C RX SYSTEM C-CLARIFYING SERUM   SKIN LIGHTENING SERUM WITH VITAMIN C
    hydroquinone liquid
    Product Information
    Item Code (Source) NDC:62032-106
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE 40 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62032-106-10 1 in 1 CARTON
    1 30 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 01/01/2004
    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 Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE 40 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62032-105-36 57 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 01/01/2004
    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 Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 105 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    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)  
    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
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62032-121-90 85 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 02/21/2013
    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 Administration TOPICAL
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    INGR WATER (UNII: 059QF0KO0R)  
    INGR GLYCERIN (UNII: PDC6A3C0OX)  
    INGR PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGR ETHYLPARABEN (UNII: 14255EXE39)  
    INGR ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    INGR BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    INGR PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    INGR METHYLPARABEN (UNII: A2I8C7HI9T)  
    INGR ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    INGR SODIUM LAUROYL OAT AMINO ACIDS (UNII: FSW2K9B9N5)  
    INGR COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    INGR SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    INGR ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    INGR SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    INGR ALFALFA (UNII: DJO934BRBD)  
    INGR CHAMOMILE (UNII: FGL3685T2X)  
    INGR XANTHAN GUM (UNII: TTV12P4NEE)  
    INGR D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    INGR FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    Color ORANGE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 177 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Cosmetic 01/01/2004
    Part 5 of 5
    OBAGI-C RX SYSTEM C-EXFOLIATING DAY  WITH VITAMIN C
    face and neck (excluding shaving preparations) lotion
    Product Information
    Route of Administration TOPICAL
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    INGR WATER (UNII: 059QF0KO0R)  
    INGR GLYCERIN (UNII: PDC6A3C0OX)  
    INGR PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGR ETHYLPARABEN (UNII: 14255EXE39)  
    INGR ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    INGR BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    INGR PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    INGR METHYLPARABEN (UNII: A2I8C7HI9T)  
    INGR POLYSORBATE 60 (UNII: CAL22UVI4M)  
    INGR GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    INGR PEG-100 STEARATE (UNII: YD01N1999R)  
    INGR ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    INGR SQUALANE (UNII: GW89575KF9)  
    INGR HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    INGR PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    INGR PEG-8 RICINOLEATE (UNII: DM36F4D2OU)  
    INGR GLYCOLIC ACID (UNII: 0WT12SX38S)  
    INGR ARGININE (UNII: 94ZLA3W45F)  
    INGR ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    INGR MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    INGR ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    INGR HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    INGR SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGR CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    INGR POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    INGR DIMETHICONE (UNII: 92RU3N3Y1O)  
    INGR STEARETH-2 (UNII: V56DFE46J5)  
    INGR ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    INGR LEVOMENOL (UNII: 24WE03BX2T)  
    INGR EDETATE SODIUM (UNII: MP1J8420LU)  
    INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 57 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Cosmetic 01/01/2004
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 04/02/2013
    Labeler - OMP, INC. (790553353)
    Establishment
    Name Address ID/FEI Business Operations
    PURETEK CORPORATION 785961046 MANUFACTURE(62032-524) , LABEL(62032-524) , PACK(62032-524)
    Establishment
    Name Address ID/FEI Business Operations
    Ei INC. 105803274 MANUFACTURE(62032-524) , LABEL(62032-524) , PACK(62032-524) , ANALYSIS(62032-524)
    Establishment
    Name Address ID/FEI Business Operations
    MILBAR LABORATORIES 195556790 MANUFACTURE(62032-524)
    Establishment
    Name Address ID/FEI Business Operations
    Bay Cities Container Corporation 066229618 RELABEL(62032-524) , REPACK(62032-524)