ZO SKIN HEALTH PIGMENT CONTROL PLUS BRIGHTENING CREME HYDROQUINONE PLUS VITAMIN C- hydroquinone emulsion 
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.

----------

ZO® Skin Health Pigment Control + Brightening Crème 4% Hydroquinone + 20% Vitamin C
National Drug Code 42851-035-##

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.)

WARNINGS

Keep out of reach of children. 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.

STORAGE

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

ACTIVE INGREDIENT

Hydroquinone 4%

INACTIVE INGREDIENTS

Ascorbic Acid, Ascorbyl Palmitate, Caprylic/Capric Triglyceride, Caprylyl Methicone, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Dimethicone Crosspolymer, Ethoxydiglycol, Helianthus Annuus (Sunflower) Seed Oil, Oleyl Alcohol, Plukenetia Volubilis Seed Oil, Retinyl Palmitate, Rosmarinus Officinalis (Rosemary) Leaf Extract, Squalane, Tocopherol, Tocopheryl Acetate, Zanthoxylum Bungeanum Fruit Extract.

Bleaches and corrects the most severe and advanced forms of hyperpigmentation in the skin with 4% hydroquinone and 20% vitamin C.

Dist. by ZO Skin Health, Inc. Irvine, CA 92618
Made in USA with US & imported materials zoskinhealth.com | 906000

PRINCIPAL DISPLAY PANEL - 81 mL Bottle Carton

ZO ® SKIN HEALTH
BY ZEIN OBAGI MD

PIGMENT CONTROL +
BRIGHTENING CRÈME

4% Hydroquinone
+ 20% Vitamin C

RX ONLY

NDC 42851-035-81

81 mL / 2.7 Fl. Oz.

PRINCIPAL DISPLAY PANEL - 81 mL Bottle Carton
ZO SKIN HEALTH PIGMENT CONTROL PLUS BRIGHTENING CREME HYDROQUINONE PLUS VITAMIN C 
hydroquinone emulsion
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42851-035
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE0.04 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
PLUKENETIA VOLUBILIS SEED OIL (UNII: 8ED72Z8J1Z)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
ROSEMARY (UNII: IJ67X351P9)  
SQUALANE (UNII: GW89575KF9)  
TOCOPHEROL (UNII: R0ZB2556P8)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ZANTHOXYLUM BUNGEANUM FRUIT (UNII: 3CIP16A418)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42851-035-811 in 1 CARTON05/01/2018
181 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/01/2018
Labeler - ZO Skin Health, Inc. (826468527)

Revised: 4/2022
Document Id: dd2fe1d6-cadc-4299-e053-2995a90a4f3e
Set id: d7bfa71b-ddce-437e-abf9-2837af82c54d
Version: 3
Effective Time: 20220421
 
ZO Skin Health, Inc.