ZO Skin Health Acne Prevention Plus Treatment Program

Manufacturer
ZO Skin Health, Inc. | G.S. COSMECEUTICAL USA, INC. | Lifetech Resources, LLC.
Effective date
2020-04-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:07:48

Label at a glance#

ProductZO Skin Health Acne Prevention Plus Treatment Program
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. 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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

SULFUR MASQUE Acne Treatment

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 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.
  • 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

Made in USA with US & imported material

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZO ® SKIN HEALTH

BY ZEIN OBAGI MD

ACNE PREVENTION

+ TREATMENT PROGRAM

ESSENTIALS FOR

ACNE-FREE SKIN

NDC 42851-175-85

US Acne Prevention Program_FullRebrand-r4US Acne Prevention Program_FullRebrand-r4

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1053330sulfur 10 % Medicated Liquid SoapPSN2
1053330sulfur 100 MG/ML Medicated Liquid SoapSCD2
1053330sulfur 10 % Medicated Liquid SoapSY2
1053330sulfur 10 % Topical MaskSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42851-175-85ZO Skin Health Acne Prevention Plus Treatment Program1 in 1 CARTONKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42851-175ZO SKIN HEALTH ACNE PREVENTION PLUS TREATMENT PROGRAM (SULFUR) KIT [ZO SKIN HEALTH, INC.]2Legacy NDC, 1 package rows20200425_a3d13786-0612-333f-e053-2a95a90a8f57.zip

Products#

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

DailyMed product names page 1 of 2 · 72 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42851-17542851-175-85
42851-089

Ingredients#

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

DailyMed ingredient rows page 1 of 3 · 84 matching rows.

Source Document#

Source XML · Source PDF

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
a40f16db-e208-ce8c-e053-2a95a90aa123a3d13786-0612-333f-e053-2a95a90a8f572020-04-24WarningsExact identifier
spl id: a40f16db-e208-ce8c-e053-2a95a90aa123
spl set id: a3d13786-0612-333f-e053-2a95a90a8f57

Reported adverse events (FAERS/openFDA)#

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