ZO MEDICAL ZO MULTI-THERAPY HYDROQUINONE SYSTEM- hydroquinone and titanium dioxide 
ZO Skin Health, Inc.

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.

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ZO® Multi-Therapy Hydroquinone System

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.

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
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 CARTON03/01/201408/27/2017
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 other03/01/201408/27/2017
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)

Revised: 12/2022
 
ZO Skin Health, Inc.