ZO SKIN HEALTH SULFUR MASQUE- sulfur cream 
ZO Skin Health, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

ZO ® Skin Health Sulfur Masque
National Drug Code 42851-089-85

Drug Facts

Active Ingredients

Sulfur 10%

Purpose

Acne Treatment

Uses

Warnings

For external use only.

When using this product

  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.
    If irritation occurs, only use one topical acne medication at a time.
  • apply only to areas with acne.

Do not use on

  • broken skin
  • large areas of the skin

Keep out of reach of children.

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive Ingredients

Water, Talc, Kaolin, Glycerin, Bentonite, Propylene Glycol, Caprylyl Glycol, Ethylene Brassylate, Silica, Tetrasodium EDTA, Phenoxyethanol, Chlorphenesin, Benzyl Alcohol, Ultramarines.

Dist. by ZO Skin Health, Inc. Irvine, CA 92618

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

ZO ® SKIN HEALTH
BY ZEIN OBAGI MD

NDC 42851-089-85

SULFUR MASQUE
10% Sulfur

Net Wt. 85 g / 3 Oz.

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
ZO SKIN HEALTH SULFUR MASQUE 
sulfur cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-089
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
TALC (UNII: 7SEV7J4R1U)  
KAOLIN (UNII: 24H4NWX5CO)  
GLYCERIN (UNII: PDC6A3C0OX)  
BENTONITE (UNII: A3N5ZCN45C)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
EDETATE SODIUM (UNII: MP1J8420LU)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ULTRAMARINE BLUE (UNII: I39WR998BI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42851-089-851 in 1 CARTON02/22/201904/09/2022
185 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D02/22/2019
Labeler - ZO Skin Health, Inc. (826468527)

Revised: 5/2022
Document Id: de990f96-96be-406d-e053-2995a90abebb
Set id: 775d1080-aee4-4ea9-808d-481a9b3cbe48
Version: 4
Effective Time: 20220509
 
ZO Skin Health, Inc.