FDA.reportPublic FDA data

ZO Skin Health Retinol Plus Acne Complex

Manufacturer
ZO Skin Health, Inc.
Effective date
2024-10-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:34:18

Label at a glance#

ProductZO Skin Health Retinol Plus Acne Complex
Active ingredientSALICYLIC ACID
Label structure2 sections

Label contents#

Full prescribing information#

Drug Facts

INDICATIONS & USAGE SECTION

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active IngredientsPurpose
Salicylic Acid 2.0%Acne Medication

Uses

OTC - PURPOSE SECTION

  • For the management of acne.
  • Penetrates pores to control acne blemishes.
  • Helps prevent new acne blemishes from forming.

Warnings

WARNINGS SECTION

OTHER SAFETY INFORMATION

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 mediation at the same time. If irritation occurs, only use one topical acne medication at a time.
Stop use and ask a doctor

OTC - STOP USE SECTION

  • if irritation occurs or gets worse.
Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • 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.

Other Information

STORAGE AND HANDLING SECTION

  • Protect this product from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Cocamidopropyl Dimethylamine, Glycerin,
Sclerotium Gum, Dimethicone, Silica, Cetyl Glyceryl
Ether, Retinol, Cetyl Alcohol, Cetyl Tranexamate
Mesylate, Carthamus Tinctorius (Safflower) Seed
Oil, Olea Europaea (Olive) Fruit Oil, Rosa Canina Fruit
Extract, Leontopodium Alpinum Meristem Cell
Culture, Marrubium Vulgare Meristem Cell Culture,
Lecithin, Propanediol, Potassium Azeloyl
Diglycinate, BHT, Pentaerythrityl Tetra-di-t-butyl
Hydroxyhydrocinnamate, Sodium Bisulfite, Sodium
Metabisulfite, Sodium Sulfite, Sodium Sulfate,
Polysorbate 20, Acrylamide/Sodium
Acryloyldimethyltaurate Copolymer, Butylene Glycol,
Isohexadecane, Bakuchiol, Aminomethyl Propanol,
Caprylhydroxamic Acid, Disodium EDTA,
Polysorbate 80, Phenoxyethanol, Ethylhexylglycerin.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZO® SKIN HEALTH
BY ZEIN OBAGI, MD

NDC 42851-093-50

RETINOL + ACNE COMPLEX
50 mL / 1.7 Fl. Oz.

Dist. by ZO Skin Health, Inc. Irvine, CA 92618
Made in USA with US & imported materials
zoskinhealth.com | 917200

Outer LabelOuter Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42851-093-50ZO Skin Health Retinol Plus Acne Complex1 in 1 CARTONLOTION12
42851-093-50ZO Skin Health Retinol Plus Acne Complex50 mL in 1 TUBELOTION502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42851-093ZO SKIN HEALTH RETINOL PLUS ACNE COMPLEX (SALICYLIC ACID) LOTION [ZO SKIN HEALTH, INC.]2Current NDC, 2 package rows20241107_1d65e4d2-0856-9135-e063-6294a90a5c66.zip

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42851-09342851-093-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMINOMETHYLPROPANOLLU49E6626QIACT
SALICYLIC ACIDO414PZ4LPZACTIB
BAKUCHIOLOT12HJU3ARIACT
COCAMIDOPROPYL DIMETHYLAMINEL36BM7DG2TIACT
RETINOLG2SH0XKK91IACT
OLIVE OIL6UYK2W1W1EIACT
POTASSIUM AZELOYL DIGLYCINATEN02RVN6NYPIACT
SODIUM BISULFITETZX5469Z6IIACT
ISOHEXADECANE918X1OUF1EIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)255PIF62MSIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
DIMETHICONE, UNSPECIFIED92RU3N3Y1OIACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
SODIUM SULFATE0YPR65R21JIACT
CETYL GLYCERYL ETHERP9FNL3D0MNIACT
PROPANEDIOL5965N8W85TIACT
ROSA CANINA FRUIT3TNW8D08V3IACT
WATER059QF0KO0RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
BETASIZOFIRAN2X51AD1X3TIACT
SODIUM METABISULFITE4VON5FNS3CIACT
POLYSORBATE 207T1F30V5YHIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
EDETATE DISODIUM7FLD91C86KIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 806OZP39ZG8HIACT
SODIUM SULFITEVTK01UQK3GIACT
SAFFLOWER SEED8FCL6A31TXIACT
CETYL ALCOHOL936JST6JCNIACT

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 Retinol Plus Acne ComplexSALICYLIC ACIDZO Skin Health, Inc.1d65e4d2-0856-9135-e063-6294a90a5c662024-10-01WarningsExact identifier
ndc (package): 42851-093-50
ndc (product): 42851-093
ndc11 (package): 42851009350
spl id: 236d92c7-984c-a9c2-e063-6394a90aebfa
spl set id: 1d65e4d2-0856-9135-e063-6294a90a5c66

Reported adverse events (FAERS/openFDA)#

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