FDA.reportPublic FDA data

ZO Skin Health Sulfur Masque

Manufacturer
ZO Skin Health, Inc.
Effective date
2022-05-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:49:32

Label at a glance#

ProductZO Skin Health Sulfur Masque
Active ingredientSULFUR
Label structure9 sections

Indications and uses

For the treatment of acne. Penetrates pores to clear most acne blemishes, blackheads, and whiteheads. Helps prevent new acne blemishes from forming.

Dosage and administration

Clean the skin thoroughly before applying this product. Cover the entire affected area with a thin layer twice a week. Suitable for use on face, chest, back or wherever breakouts occur. Leave on for 10-15 minutes and remove thoroughly with warm water, moist towels or cotton pads. If bothersome dryness or peeling occurs, reduce application frequency as directed by your doctor. As a spot treatment: apply a small amo...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Sulfur 10%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

  • For the treatment of acne.
  • Penetrates pores to clear most acne blemishes, blackheads, and whiteheads.
  • Helps prevent new acne blemishes from forming.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - DO NOT USE SECTION

  • broken skin
  • large areas of the skin

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean the skin thoroughly before applying this product.
  • Cover the entire affected area with a thin layer twice a week.
  • Suitable for use on face, chest, back or wherever breakouts occur.
  • Leave on for 10-15 minutes and remove thoroughly with warm water, moist towels or cotton pads.
  • If bothersome dryness or peeling occurs, reduce application frequency as directed by your doctor.
  • As a spot treatment: apply a small amount onto the blemish and leave on overnight.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1053330sulfur 10 % Medicated Liquid SoapPSN4
1053330sulfur 100 MG/ML Medicated Liquid SoapSCD4
1053330sulfur 10 % Medicated Liquid SoapSY4
1053330sulfur 10 % Topical MaskSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42851-089-852024-01-30C16284748780-11030e365-2b73-111a-e063-dadaa90a10e2ZO ® Skin Health Sulfur Masque National Drug Code 42851-089-85

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42851-089-85ZO Skin Health Sulfur Masque85 g in 1 TUBECREAM854
42851-089-85ZO Skin Health Sulfur Masque1 in 1 CARTONCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42851-089ZO SKIN HEALTH SULFUR MASQUE (SULFUR) CREAM [ZO SKIN HEALTH, INC.]4Legacy NDC, 2 package rows20220511_775d1080-aee4-4ea9-808d-481a9b3cbe48.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42851-08942851-089-85

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
TALC7SEV7J4R1UIACT
KAOLIN24H4NWX5COIACT
GLYCERINPDC6A3C0OXIACT
BENTONITEA3N5ZCN45CIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CAPRYLYL GLYCOL00YIU5438UIACT
ETHYLENE BRASSYLATE9A87HC7RODIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
EDETATE SODIUMMP1J8420LUIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CHLORPHENESINI670DAL4SZIACT
BENZYL ALCOHOLLKG8494WBHIACT
ULTRAMARINE BLUEI39WR998BIIACT
SULFUR70FD1KFU70ACTIB

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
de990f96-96be-406d-e053-2995a90abebb775d1080-aee4-4ea9-808d-481a9b3cbe482022-05-09WarningsExact identifier
spl id: de990f96-96be-406d-e053-2995a90abebb
spl set id: 775d1080-aee4-4ea9-808d-481a9b3cbe48

Reported adverse events (FAERS/openFDA)#

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