ZO Skin Health Multi-Therapy Hydroquinone System

Manufacturer
ZO Skin Health, Inc. | G.S. COSMECEUTICAL USA, INC. | PhytogenX, Inc. | PakLab
Effective date
2018-02-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:02:49

Label at a glance#

ProductZO Skin Health Multi-Therapy Hydroquinone System
Active ingredientHydroquinone
Label structure18 sections

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.)

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

MELAMIN™ Skin Bleaching & Correcting Crème

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

WARNINGS SECTION

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

PRECAUTIONS SECTION

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

STORAGE AND HANDLING SECTION

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

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Hydroquinone 4%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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.

SPL UNCLASSIFIED SECTION

MELAMIX™ Skin Lightener & Blending Crème

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

WARNINGS SECTION

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

PRECAUTIONS SECTION

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

STORAGE AND HANDLING SECTION

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

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Hydroquinone 4%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
PRINCIPAL DISPLAY PANEL - Kit Carton

FDA-Initiated Inactive NDC Indexing#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 3 · 81 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42851-18542851-185-79
42851-03242851-032-32
42851-03342851-033-32

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 3 · 109 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
efd113cc-958e-730f-e053-2a95a90a1ee426c4c405-c698-4de4-a98f-33a29490aa0a2022-12-14WarningsExact identifier
spl set id: 26c4c405-c698-4de4-a98f-33a29490aa0a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.