ZO MEDICAL ZO MULTI-THERAPY HYDROQUINONE SYSTEM (HYDROQUINONE AND TITANIUM DIOXIDE) KIT [ZO SKIN HEALTH, INC.]

ZO MEDICAL ZO MULTI-THERAPY HYDROQUINONE SYSTEM (HYDROQUINONE AND TITANIUM DIOXIDE) KIT [ZO SKIN HEALTH, INC.]
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NDC 42851-030-32, 42851-031-32, 42851-052-60, 42851-131-98
Set ID 3f9bd7a0-3aa1-484d-a72a-e75d4f81f7e7
Category HUMAN PRESCRIPTION DRUG LABEL
Packager ZO Skin Health, Inc.
Generic Name
Product Class
Product Number
Application Number
  • MELAMIN™ Skin Bleaching & Correcting Crème

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

  • DOSAGE AND ADMINISTRATION

    After cleansing, apply 2 pumps (1 g) to affected areas twice a day or as directed by a physician. Always use sunscreen protection. (See enclosed package insert for full prescribing information.)

  • WARNINGS

    Keep out of reach of children. Contains sodium metabisulfite, a sulfite that may cause serious allergic-type reactions including anaphylactic symptoms (e.g. hives, itching), and life threatening or less severe asthmatic episodes in certain susceptible persons. For external use only. Avoid contact with the eyes. Some users may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a physician. Do not use on children under 12 years of age unless directed by a physician. If swallowed, get medical help or contact a poison control center right away.

  • 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.

  • STORAGE

    Store at controlled room temperature: 15°-30°C (59°-86°F), away from direct sunlight.

  • ACTIVE INGREDIENT

    Hydroquinone 4%

  • INACTIVE INGREDIENTS

    Water (Aqua), Ascorbic Acid, Glycolic Acid, Cetyl Alcohol, Glycerin, Sodium Lauryl Sulfate, Stearyl Alcohol, Tocopheryl Acetate, BHT, Disodium EDTA, Methylparaben, Propylparaben, Saponins, Sodium Metabisulfite.

  • MELAMIX™ Skin Lightener & Blending Crème

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

  • DOSAGE AND ADMINISTRATION

    Combine 1g tretinoin with 1 pump Melamix™ at night to affected areas or as directed by a physician, directly following Melamin™ for a gradual bleaching of hyperpigmented skin conditions. (See enclosed package insert for full prescribing information.)

    MildStart 1-2×/week, increasing as tolerated.
    ModerateUse every other day, increasing as tolerated.
    AggressiveUse every AM and PM as tolerated. Always use sunscreen protection.
  • WARNINGS

    Keep out of reach of children. Contains sodium metabisulfite, a sulfite that may cause serious allergic-type reactions including anaphylactic symptoms (e.g. hives, itching), and life threatening or less severe asthmatic episodes in certain susceptible persons. For external use only. Avoid contact with the eyes. Some users may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a physician. Do not use on children under 12 years of age unless directed by a physician. If swallowed, get medical help or contact a poison control center right away.

  • 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.

  • STORAGE

    Store at controlled room temperature: 15°-30°C (59°-86°F), away from direct sunlight.

  • ACTIVE INGREDIENT

    Hydroquinone 4%

  • INACTIVE INGREDIENTS

    Water (Aqua), Glycolic Acid, Glycerin, Cetyl Alcohol, Ethylhexyl Palmitate, Ascorbic Acid, Sodium Lauryl Sulfate, Phenyl Trimethicone, Saponins, Tocopheryl Acetate, Methylparaben, Propylparaben, Sodium Metabisulfite, BHT, Disodium EDTA.

  • OCLIPSE-C™ Broad-Spectrum Sunscreen SPF 50

    Drug Facts

  • Active ingredient

    Titanium Dioxide 8%

  • Purpose

    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 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.

  • Other information

    • Store product in a cool place away from direct heat and sunlight.
    • You may report a serious adverse reaction to: 1 Technology Dr. B123, Irvine, CA 92618
  • Directions

    • For full protection, apply liberally 15 minutes before sun exposure.
    • Use a water resistant sunscreen if swimming or sweating.
    • Reapply at least every 2 hours.
    • For children under 6 months of age: ask a doctor.
    • Sun Protection Measures. Spending time in the sun increases your risk off 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.
    • Apply to all skin exposed to the sun.
  • Inactive ingredients

    Water (Aqua), Aluminum Hydroxide, Stearic Acid, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Cyclopentasiloxane, Phenyl Trimethicone, Styrene/Acrylates Copolymer, Pentylene Glycol, Dimethicone, Glycerin, Isodecyl Neopentanoate, Diisopropyl Sebacate, Lauryl Lactate, Polyacrylamide, Disodium EDTA, Phytosphingosine, Ceteareth-20, Cetearyl Alcohol, PEG-100 Stearate, Glyceryl Stearate, Sodium Dihydroxycetyl Phosphate, Hydrogenated Palm Glycerides, Melanin, Ethylhexylglycerin, Erythritol, Homarine HCL, Sodium Benzoate, Potassium Sorbate, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Nephelium Lappaceum Peel Extract, Glycine Soja Extract, Silica, C13-14 Isoparaffin, Laureth-7.

  • SPL UNCLASSIFIED SECTION

    DIST BY
    ZO Skin Health, Inc. Irvine, CA 92618

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    ZO® MULTI-THERAPY HYDROQUINONE SYSTEM

    NDC 42851-131-98

    ZO® MEDICAL
    BY ZEIN OBAGI, MD

    RX
    ONLY

    Principal Display Panel - Kit Carton
  • INGREDIENTS AND APPEARANCE
    ZO MEDICAL   ZO MULTI-THERAPY HYDROQUINONE SYSTEM
    hydroquinone and titanium dioxide kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42851-131
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42851-131-981 in 1 CARTON03/01/2014
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 32 g
    Part 21 BOTTLE, PLASTIC 32 g
    Part 31 TUBE 60 g
    Part 41 BOTTLE, PLASTIC 30 mL
    Part 51 BOTTLE, PUMP 30 mL
    Part 1 of 5
    MELAMIN SKIN BLEACHING AND CORRECTING 
    hydroquinone cream
    Product Information
    Item Code (Source)NDC:42851-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Hydroquinone (UNII: XV74C1N1AE) (Hydroquinone - UNII:XV74C1N1AE) Hydroquinone0.04 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Ascorbic Acid (UNII: PQ6CK8PD0R)  
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Glycerin (UNII: PDC6A3C0OX)  
    Glycolic Acid (UNII: 0WT12SX38S)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Water (UNII: 059QF0KO0R)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Sodium Metabisulfite (UNII: 4VON5FNS3C)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42851-030-3232 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER01/01/2012
    Part 2 of 5
    MELAMIX SKIN LIGHTENER AND BLENDING 
    hydroquinone cream
    Product Information
    Item Code (Source)NDC:42851-031
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Hydroquinone (UNII: XV74C1N1AE) (Hydroquinone - UNII:XV74C1N1AE) Hydroquinone0.04 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Ascorbic Acid (UNII: PQ6CK8PD0R)  
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    Glycerin (UNII: PDC6A3C0OX)  
    Glycolic Acid (UNII: 0WT12SX38S)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Water (UNII: 059QF0KO0R)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Sodium Metabisulfite (UNII: 4VON5FNS3C)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42851-031-3232 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER01/01/2012
    Part 3 of 5
    ZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50 
    titanium dioxide lotion
    Product Information
    Item Code (Source)NDC:42851-052
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.08 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURYL LACTATE (UNII: G5SU0BFK7O)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
    POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    SODIUM DIHYDROXYCETYL PHOSPHATE (UNII: YWI33EV595)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
    MELAMINE (UNII: N3GP2YSD88)  
    ERYTHRITOL (UNII: RA96B954X6)  
    HOMARINE HYDROCHLORIDE (UNII: 8866LNG61N)  
    NEPHELIUM LAPPACEUM FRUIT RIND (UNII: Y0513T90FO)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42851-052-6060 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35206/01/2013
    Part 4 of 5
    ZO MEDICAL GLYCOGENT EXFOLIATION ACCELERATOR CONCENTRATION 
    cleansing (cold creams, cleansing lotions, liquids, and pads) lotion
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRGLYCOLIC ACID (UNII: 0WT12SX38S)  
    INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    INGRLACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRPROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
    INGRSQUALANE (UNII: GW89575KF9)  
    INGRPROPYLENE GLYCOL MONOSTEARATE (UNII: MZM1I680W0)  
    INGRSTEAPYRIUM CHLORIDE (UNII: C9842BS3SX)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
    INGRSAFFLOWER OIL (UNII: 65UEH262IS)  
    INGRALLANTOIN (UNII: 344S277G0Z)  
    INGRGREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRSODIUM CARBONATE (UNII: 45P3261C7T)  
    INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
    INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRVITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    INGRTOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    COSMETIC01/01/2012
    Part 5 of 5
    OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA 
    cleansing (cold creams, cleansing lotions, liquids, and pads) lotion
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRCETEARYL ISONONANOATE (UNII: P5O01U99NI)  
    INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    INGRCYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    INGRPENTYLENE GLYCOL (UNII: 50C1307PZG)  
    INGRRETINOL (UNII: G2SH0XKK91)  
    INGREGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRSTEARETH-20 (UNII: L0Q8IK9E08)  
    INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    INGRJOJOBA BUTTER (UNII: XIA46H803R)  
    INGRVITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRCURDLAN (UNII: 6930DL209R)  
    INGRLACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    INGRORANGE OIL (UNII: AKN3KSD11B)  
    INGRMANDARIN OIL (UNII: NJO720F72R)  
    INGRLEMON OIL (UNII: I9GRO824LL)  
    INGRPEPPERMINT OIL (UNII: AV092KU4JH)  
    INGRMIMOSA TENUIFLORA BARK (UNII: 515MQE449I)  
    INGRARABIDOPSIS THALIANA (UNII: AI3L60HQ81)  
    INGRC14-22 ALCOHOLS (UNII: B1K89384RJ)  
    INGRCETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    INGRC12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    INGRPOWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGRPALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)  
    INGRPALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    INGRHYPROMELLOSES (UNII: 3NXW29V3WO)  
    INGRHEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRLIMONENE, (+/-)- (UNII: 9MC3I34447)  
    INGRULTRAMARINE BLUE (UNII: I39WR998BI)  
    INGREXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    COSMETIC01/11/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other03/01/2014
    Labeler - ZO Skin Health, Inc. (826468527)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sanitor Corporation797472792MANUFACTURE(42851-131)
    Establishment
    NameAddressID/FEIBusiness Operations
    PhytogenX, Inc.624386772MANUFACTURE(42851-131)
    Establishment
    NameAddressID/FEIBusiness Operations
    PAKLAB790530976MANUFACTURE(42851-131)

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