FDA.reportPublic FDA data

ZO Skin Health Acne Control Benzoyl Peroxide

Manufacturer
ZO Skin Health, Inc.
Effective date
2024-10-28
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:30:52

Label at a glance#

ProductZO Skin Health Acne Control Benzoyl Peroxide
Active ingredientBENZOYL PEROXIDE
Label structure10 sections

Indications and uses

For the treatment of acne.

Dosage and administration

Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below. Clean the skin thoroughly before applying this product. Cover the entire affected area with a thin layer one to three times daily. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to...

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 10%

Purpose

OTC - PURPOSE SECTION

Acne Medication

Uses

INDICATIONS & USAGE SECTION

For the treatment of acne.

Warnings

WARNINGS SECTION

For external use only.

Do not use if you

OTC - DO NOT USE SECTION

  • have very sensitive skin
  • are sensitive to benzoyl peroxide.

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.
  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with the eyes, lips, and mouth
  • avoid contact with hair and dyed fabrics, which may be bleached by this product
  • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation becomes severe

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

Sensitivity Test for a New User.

Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.

  • Clean the skin thoroughly before applying this product.
  • Cover the entire affected area with a thin layer one to three times daily.
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Other Information

STORAGE AND HANDLING SECTION

  • Protect this product from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua/Water/Eau, Aspalathus Linearis Leaf Extract, Camellia Sinensis Leaf Extract, Carbomer, Diethylhexyl Sodium Sulfosuccinate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glycerin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, PEG-40 Stearate, PEG-8 Laurate, Phenoxyethanol, Pinus Strobus Bark Extract, Polyglyceryl-6 Isostearate, Propanediol, Propylene Glycol, Silica, Sodium Citrate, Sodium Hydroxide, Sorbitan Stearate, Vitis Vinifera (Grape) Seed Extract, Xanthan Gum.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZO ® SKIN HEALTH
BY ZEIN OBAGI MD

NDC 42851-087-60

ACNE CONTROL
10% Benzoyl Peroxide

60 mL / 2 Fl. Oz.

PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton
PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106315benzoyl peroxide 10 % Topical CreamPSN6
106315benzoyl peroxide 100 MG/ML Topical CreamSCD6
106315benzoyl peroxide 10 % Topical CreamSY6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42851-087-60ZO Skin Health Acne Control Benzoyl Peroxide60 mL in 1 TUBECREAM606
42851-087-60ZO Skin Health Acne Control Benzoyl Peroxide1 in 1 CARTONCREAM16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42851-087ZO SKIN HEALTH ACNE CONTROL BENZOYL PEROXIDE (BENZOYL PEROXIDE) CREAM [ZO SKIN HEALTH, INC.]6Current NDC, Legacy NDC, 2 package rows20241030_252b2352-a457-4009-a62b-0ec98f018b2e.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42851-08742851-087-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ASPALATHUS LINEARIS LEAFH7UGK1GJCUIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
DOCUSATE SODIUMF05Q2T2JA0IACT
DIMETHICONE92RU3N3Y1OIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
TEA TREE OILVIF565UC2GIACT
PEG-40 STEARATEECU18C66Q7IACT
PEG-8 LAURATE762O8IWA10IACT
PHENOXYETHANOLHIE492ZZ3TIACT
PINUS STROBUS BARK8PJ4761097IACT
POLYGLYCERYL-6 ISOSTEARATE5VKGO1O03GIACT
PROPANEDIOL5965N8W85TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SODIUM HYDROXIDE55X04QC32IIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
VITIS VINIFERA SEEDC34U15ICXAIACT
XANTHAN GUMTTV12P4NEEIACT
BENZOYL PEROXIDEW9WZN9A0GMACTIB

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
ZO Skin Health Acne Control Benzoyl PeroxideBENZOYL PEROXIDEZO Skin Health, Inc.252b2352-a457-4009-a62b-0ec98f018b2e2024-10-28WarningsExact identifier
ndc (package): 42851-087-60
ndc (product): 42851-087
ndc11 (package): 42851008760
spl id: 2591f131-83b9-f843-e063-6294a90a790f
spl set id: 252b2352-a457-4009-a62b-0ec98f018b2e

Reported adverse events (FAERS/openFDA)#

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