ZO SKIN HEALTH MULTI-THERAPY HYDROQUINONE SYSTEM- hydroquinone 
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 ® SKIN HEALTH

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

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

Aqua/Water/Eau, Ascorbic Acid, Ascorbyl Palmitate, Beta-Glucan, Brassica Oleracea Italica (Broccoli) Extract, C10-16 Alcohols, Caprylyl Glycol, Cetyl Alcohol, Chlorphenesin, Dioscorea Villosa (Wild Yam) Root Extract, Disodium EDTA, Glycerin, Glycolic Acid, Helianthus Annuus (Sunflower) Seed Oil, Maltodextrin, Phenoxyethanol, Quillaja Saponaria Bark Extract, Smilax Aristolochiifolia Root Extract, Sodium Lauryl Sulfate, Sodium Metabisulfite, Stachys Officinalis Flower/ Leaf/Stem Extract, Stearyl Alcohol, Tocopherol, Tocopheryl Acetate, Yucca Schidigera Root Extract.

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

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, Cetyl Alcohol, Glycerin, Ethylhexyl Palmitate, Sodium Lauryl Sulfate, Stearyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Maltodextrin, Phenyl Trimethicone, Tocopheryl Acetate, Phenoxyethanol, Ascorbic Acid, Aminopropyl Dihydrogen Phosphate, Beta-Glucan, Sodium Metabisulfite, Glycolic Acid, Brassica Oleracea Italica (Broccoli) Sprout Powder, Ascorbyl Palmitate, Chlorphenesin, Caprylyl Glycol, Disodium EDTA, Stachys Officinalis Flower/Leaf/ Stem Extract, Saponins, Sodium Sulfite.

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

PRINCIPAL DISPLAY PANEL - Kit Carton

ZO ® SKIN HEALTH
BY ZEIN OBAGI MD

MULTI-THERAPY HYDROQUINONE SYSTEM

NDC 42851-185-79

MELAMIN™ Net Wt. 32 g / 1.12 Oz.
EXFOLIATION ACCELERATOR 30 mL / 1 Fl. Oz.
MELAMIX™ Net Wt. 32 g / 1.12 Oz.
DAILY POWER DEFENSE 30 mL / 1 Fl. Oz.

PRINCIPAL DISPLAY PANEL - Kit Carton
ZO SKIN HEALTH MULTI-THERAPY HYDROQUINONE SYSTEM 
hydroquinone kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42851-185
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42851-185-791 in 1 CARTON03/01/201804/01/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 32 g
Part 21 BOTTLE, PLASTIC 32 g
Part 31 BOTTLE, PLASTIC 30 mL
Part 41 BOTTLE, PUMP 30 mL
Part 1 of 4
MELAMIN SKIN BLEACHING AND CORRECTING HYDROQUINONE 
hydroquinone cream
Product Information
Item Code (Source)NDC:42851-032
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
WATER (UNII: 059QF0KO0R)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
QUILLAJA SAPONARIA BARK (UNII: 8N0K3807ZW)  
SMILAX ARISTOLOCHIIFOLIA ROOT (UNII: NR100Y25G0)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
STACHYS OFFICINALIS FLOWERING TOP (UNII: D7A759WU38)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
TOCOPHEROL (UNII: R0ZB2556P8)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42851-032-3232 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 other03/01/2018
Part 2 of 4
MELAMIX SKIN LIGHTENER AND BLENDING 
hydroquinone cream
Product Information
Item Code (Source)NDC:42851-033
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
WATER (UNII: 059QF0KO0R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
AMINOPROPYL DIHYDROGEN PHOSPHATE (UNII: D5J0Q2CM4V)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
BROCCOLI SPROUT (UNII: 128UH9LOAE)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
STACHYS OFFICINALIS FLOWERING TOP (UNII: D7A759WU38)  
SODIUM SULFITE (UNII: VTK01UQK3G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42851-033-3232 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 other03/01/2018
Part 3 of 4
ZO SKIN HEALTH EXFOLIATION ACCELERATOR 
lotions, oils, powders, and creams 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)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRPROPYLENE GLYCOL MONOSTEARATE (UNII: MZM1I680W0)  
INGRPROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
INGRAMMONIA (UNII: 5138Q19F1X)  
INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
INGRSQUALANE (UNII: GW89575KF9)  
INGRSTEAPYRIUM CHLORIDE (UNII: C9842BS3SX)  
INGRALLANTOIN (UNII: 344S277G0Z)  
INGREDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRSAFFLOWER OIL (UNII: 65UEH262IS)  
INGRCHAMOMILE (UNII: FGL3685T2X)  
INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
INGRGREEN TEA LEAF (UNII: W2ZU1RY8B0)  
INGRVITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
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
Cosmetic03/01/2018
Part 4 of 4
ZO SKIN HEALTH DAILY POWER DEFENSE 
lotions, oils, powders, and creams lotion
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRCETEARYL ISONONANOATE (UNII: P5O01U99NI)  
INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRCYCLOMETHICONE 6 (UNII: XHK3U310BA)  
INGRPENTYLENE GLYCOL (UNII: 50C1307PZG)  
INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
INGRSTEARETH-20 (UNII: L0Q8IK9E08)  
INGRC14-22 ALCOHOLS (UNII: B1K89384RJ)  
INGRCETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
INGRC12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
INGRCARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
INGRLACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
INGRPOWDERED CELLULOSE (UNII: SMD1X3XO9M)  
INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
INGRRETINOL (UNII: G2SH0XKK91)  
INGR1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
INGRHYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
INGRARABIDOPSIS THALIANA (UNII: AI3L60HQ81)  
INGRORANGE OIL (UNII: AKN3KSD11B)  
INGRMANDARIN OIL (UNII: NJO720F72R)  
INGRLEMON OIL (UNII: I9GRO824LL)  
INGRPEPPERMINT OIL (UNII: AV092KU4JH)  
INGRMIMOSA TENUIFLORA BARK (UNII: 515MQE449I)  
INGRTANGERINE (UNII: KH3E3096OO)  
INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
INGRFARNESOL (UNII: EB41QIU6JL)  
INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
INGREDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRPALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
INGRPALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
INGRVITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
INGRHEXYLENE GLYCOL (UNII: KEH0A3F75J)  
INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
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
Cosmetic03/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/01/201804/01/2020
Labeler - ZO Skin Health, Inc. (826468527)
Establishment
NameAddressID/FEIBusiness Operations
G.S. COSMECEUTICAL USA, INC.017014734manufacture(42851-185)
Establishment
NameAddressID/FEIBusiness Operations
PhytogenX, Inc.624386772manufacture(42851-185)
Establishment
NameAddressID/FEIBusiness Operations
PakLab790530976manufacture(42851-185)

Revised: 12/2022
 
ZO Skin Health, Inc.