FDA.reportPublic FDA data

ZO® Skin Health Pigment Control + Blending Crème 4% Hydroquinone

Manufacturer
ZO Skin Health, Inc.
Effective date
2026-08-20
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-08-22 01:02:11

Label at a glance#

ProductZO Skin Health Pigment Control Plus Blending Creme Hydroquinone
Active ingredientHYDROQUINONE
Label structure8 sections

Dosage and administration

Apply 2 pumps (1g) 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

Blending crème containing 4% hydroquinone, the optimal concentration for melanin inhibition to correct skin pigmentation disorders.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Apply 2 pumps (1g) 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

SPL UNCLASSIFIED 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 afterward.

STORAGE

STORAGE AND HANDLING SECTION

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

ACTIVE INGREDIENT

SPL UNCLASSIFIED SECTION

Hydroquinone 4%

INACTIVE INGREDIENTS

SPL UNCLASSIFIED SECTION

Ascorbic Acid, Ascorbyl Palmitate, Beta-Glucan, Caprylyl Glycol, Cetyl Alcohol, Chlorphenesin, Dioscorea Villosa (Wild Yam) Root Extract, Disodium EDTA, Ethylhexyl Palmitate, Glycerin, Glycolic Acid, Palmitic Acid, Phenoxyethanol, Phenyl Trimethicone, Quillaja Saponaria Bark Extract, Smilax Aristolochiifolia Root Extract, Sodium Hydroxide, Sodium Lauryl Sulfate, Sodium Metabisulfite, Sodium Sulfite, Stearyl Alcohol, Tocopheryl Acetate, Water, Yucca Schidigera Root Extract.

SPL UNCLASSIFIED SECTION

Dist. by ZO Skin Health, Inc. Irvine, CA 92618
Made in USA with US & imported materials
zoskinhealth.com | 905700

PRINCIPAL DISPLAY PANEL - 80 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZO ® SKIN HEALTH

BY ZEIN OBAGI MD

PIGMENT CONTROL +

BLENDING CRÈME

4% Hydroquinone

RX ONLY

NDC 42851-036-80

80 mL / 2.7 Fl. Oz.

PDPPDP

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42851-03642851-036-80, 42851-036-33, 42851-036-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROQUINONEXV74C1N1AEACTIB
ASCORBIC ACIDPQ6CK8PD0RIACT
ASCORBYL PALMITATEQN83US2B0NIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CETYL ALCOHOL936JST6JCNIACT
CHLORPHENESINI670DAL4SZIACT
DIOSCOREA VILLOSA TUBERIWY3IWX2G8IACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ETHYLHEXYL PALMITATE2865993309IACT
GLYCERINPDC6A3C0OXIACT
GLYCOLIC ACID0WT12SX38SIACT
PALMITIC ACID2V16EO95H1IACT
PHENOXYETHANOLHIE492ZZ3TIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
QUILLAJA SAPONARIA BARK8N0K3807ZWIACT
SMILAX ARISTOLOCHIIFOLIA ROOTNR100Y25G0IACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM METABISULFITE4VON5FNS3CIACT
SODIUM SULFATE0YPR65R21JIACT
SODIUM SULFITEVTK01UQK3GIACT
STEARYL ALCOHOL2KR89I4H1YIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
YUCCA SCHIDIGERA ROOTE2H9ET15ATIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42022-04-22full-release2026-05-31 20:41:11

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
ZO Skin Health Pigment Control Plus Blending Creme HydroquinoneHYDROQUINONEZO Skin Health, Inc.c29cbc80-cb97-42d0-b796-ee487b0e85c52026-08-20WarningsExact identifier
ndc (package): 42851-036-30
ndc (package): 42851-036-33
ndc (package): 42851-036-80
ndc (product): 42851-036
ndc11 (package): 42851003680
ndc11 (package): 42851003633
ndc11 (package): 42851003630
spl id: 597ecde5-73ec-c85f-e063-6394a90a04ae
spl set id: c29cbc80-cb97-42d0-b796-ee487b0e85c5

Reported adverse events (FAERS/openFDA)#

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