FDA.reportPublic FDA data

ZO Skin Health Skin Normalizing System with Rozatrol Booster Serum

Manufacturer
ZO Skin Health, Inc. | Lifetech Resources, LLC | Thibiant International, Inc. | PakLab
Effective date
2020-04-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:07:10

Label at a glance#

ProductZO Skin Health Skin Normalizing System with Rozatrol Booster Serum
Active ingredientSALICYLIC ACID
Label structure10 sections

Indications and uses

For the management of acne. Penetrates pores to control acne blemishes.

Dosage and administration

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.

Storage and handling

Read the directions and warnings before use. Store at 15–30°C (59–89°F), away from direct sunlight.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2.0%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

  • For the management of acne.
  • Penetrates pores to control acne blemishes.

Warnings

WARNINGS SECTION

Flammable. Keep away from heat and open flame.

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.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • If skin irritation occurs or gets worse.

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 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.

Other Information

STORAGE AND HANDLING SECTION

  • Read the directions and warnings before use.
  • Store at 15–30°C (59–89°F), away from direct sunlight.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alcohol, Artemisia Vulgaris Extract, Butylene Glycol, Camellia Sinensis Leaf Extract, Crithmum Maritimum Extract, Fragrance, Glycolic Acid, Hamamelis Virginiana (Witch Hazel) Extract, Hordeum Vulgare Seed Extract, Mandelic Acid, Menthyl Lactate, Phenoxyethanol, Phellodendron Amureuse Extract, Plantago Lanceolata Leaf Extract, Pterocarpus Soyauxii Wood Extract, Rosa Canina Fruit Extract, Sodium Hydroxide, Spiraea Ulmaria Extract, Urea, Water.

SPL UNCLASSIFIED SECTION

Dist. by ZO Skin Health, Inc.
5 Technology Dr. Irvine, CA 92618 | 910700

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZO ® SKIN HEALTH
BY ZEIN OBAGI MD

SKIN NORMALIZING SYSTEM
WITH ROZATROL ® BOOSTER SERUM

NDC 42851-186-60

DELIVERED BY

hydrafacial ©

PRINCIPAL DISPLAY PANEL - Kit Carton
PRINCIPAL DISPLAY PANEL - Kit Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797892salicylic acid 2 % Medicated PadPSN2
1546588salicylic acid 2 % Medicated PatchPSN2
1546588salicylic acid 0.02 MG/MG Medicated PatchSCD2
797892salicylic acid 20 MG/ML Medicated PadSCD2
797892salicylic acid 2 % Medicated PadSY2
1546588salicylic acid 2 % Medicated PatchSY2
797892salicylic acid 2 % Topical SwabSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42851-186-602021-07-23C16284748780-19d75b9d0-aaa1-f424-e053-dadaa90a57ceZO ® Skin Health Skin Normalizing System with Rozatrol ® Booster Serum
42851-186-602020-04-20C16284748780-19d75b9d0-aaa1-f424-e053-dadaa90a57ceZO ® Skin Health Skin Normalizing System with Rozatrol ® Booster Serum
42851-186-602020-01-31C16284748780-19d75b9d0-aaa1-f424-e053-dadaa90a57ceZO ® Skin Health Skin Normalizing System with Rozatrol ® Booster Serum

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42851-186-60ZO Skin Health Skin Normalizing System with Rozatrol Booster Serum1 in 1 CARTONKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42851-186ZO SKIN HEALTH SKIN NORMALIZING SYSTEM WITH ROZATROL BOOSTER SERUM (SALICYLIC ACID) KIT [ZO SKIN HEALTH, INC.]2Legacy NDC, 1 package rows20200421_fa1c6499-1b23-465a-b470-7d053f5a7c0d.zip

Products#

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

DailyMed product names page 1 of 3 · 115 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42851-18642851-186-60

Ingredients#

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

DailyMed ingredient rows page 1 of 5 · 163 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RINGR
GLYCERINPDC6A3C0OXINGR
BUTYLENE GLYCOL3XUS85K0RAINGR
PENTYLENE GLYCOL50C1307PZGINGR
LACTOSEJ2B2A4N98GINGR
PROPANEDIOL5965N8W85TINGR
ROSA CANINA FRUIT3TNW8D08V3INGR
CASEIN48268V50D5INGR
PAPAINA236A06Y32INGR
TOCOPHEROLR0ZB2556P8INGR
CAPRYLYL GLYCOL00YIU5438UINGR
BETASIZOFIRAN2X51AD1X3TINGR
XANTHAN GUMTTV12P4NEEINGR
LECITHIN, SOYBEAN1DI56QDM62INGR
CARBOXYPOLYMETHYLENE0A5MM307FCINGR
SODIUM ALGINATEC269C4G2ZQINGR
PALMITOYL GLYCINEM6V3RIU5KIINGR
PEG-12 GLYCERYL LAURATEJ07WW42G15INGR
POLYOXYL 35 CASTOR OIL6D4M1DAL6OINGR
PANTHENOL TRIACETATE, (+)-1206E8961BINGR
1,2-HEXANEDIOLTR046Y3K1GINGR
LACTIC ACID, UNSPECIFIED FORM33X04XA5ATINGR
CAPRYLHYDROXAMIC ACIDUPY805K99WINGR
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRINGR
FARNESOLEB41QIU6JLINGR
FARNESYL ACETATE2ARF3ZNJ1RINGR
WATER059QF0KO0RINGR
SODIUM LAURETH-3 SULFATEBPV390UAP0INGR
COCAMIDOPROPYL BETAINE5OCF3O11KXINGR
SODIUM LAUROYL OAT AMINO ACIDSFSW2K9B9N5INGR
GLYCERINPDC6A3C0OXINGR
PTEROCARPUS SOYAUXII WOOD0V6QB4C61PINGR
PHELLODENDRON AMURENSE BARKPBG27B754GINGR
BARLEY5PWM7YLI7RINGR
GREEN TEA LEAFW2ZU1RY8B0INGR
PLANTAGO LANCEOLATA LEAF2YWL9J7EE8INGR
CRITHMUM MARITIMUMJ7IHY79BKYINGR
LIMONENE, (+)-GFD7C86Q1WINGR
LINALOOL, (+/-)-D81QY6I88EINGR
SODIUM CHLORIDE451W47IQ8XINGR

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
a3c1f0a8-c082-ae9a-e053-2995a90aa807fa1c6499-1b23-465a-b470-7d053f5a7c0d2020-04-20WarningsExact identifier
spl id: a3c1f0a8-c082-ae9a-e053-2995a90aa807
spl set id: fa1c6499-1b23-465a-b470-7d053f5a7c0d

Reported adverse events (FAERS/openFDA)#

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