FDA.reportPublic FDA data

MUSTELA® Diaper Rash Cream 1 2 3

Manufacturer
Expanscience Laboratories d/b/a Mustela
Effective date
2026-08-21
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
daily-update
Hydrated at
2026-08-26 01:01:54

Label at a glance#

ProductMUSTELA Diaper Rash 1 2 3
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

Helps treat and prevent diaper rash Protects chafed skin associated with diaper rash Helps seal out wetness

Dosage and administration

Change wet and soiled diapers promptly. Cleanse the diaper area and allow to dry. Apply cream liberally and as often as necessary and with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 9.9 %

Purpose

OTC - PURPOSE SECTION

skin protectant

Uses

INDICATIONS & USAGE SECTION

  • Helps treat and prevent diaper rash
  • Protects chafed skin associated with diaper rash
  • Helps seal out wetness

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than seven days
  • symptoms clear up and occur again within a few days

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

  • Change wet and soiled diapers promptly. Cleanse the diaper area and allow to dry.
  • Apply cream liberally and as often as necessary and with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Other information

SPL UNCLASSIFIED SECTION

  • You may report serious side effects to the phone number provided below or to Expanscience Laboratories Inc. dba Mustela, 60 E. 56th St. 6th Floor, New York, New York 10022, USA.
  • PE plastic tube ensures proper product conservation and facilitates daily use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Caprylic/capric Triglyceride, Coco-caprylate/caprate, Polyglyceryl-2-dipolyhydroxystearate, Glycerin, Beeswax, Persea Gratissima (Avocado) Oil, Polyglyceryl-3 Diisostearate, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Ethyl Linoleate, Persea Gratissima (Avocado) Fruit Extract, Magnesium Sulfate, Stearalkonium Hectorite, Levulinic Acid, Caprylyl Glycol, Capryloyl Glycine, Sodium Levulinate, Undecyl Dimethyl Oxazoline, Propylene Carbonate

Questions or comments ?

OTC - QUESTIONS SECTION

Call toll free 1-800-422-2987 Monday-Friday 9:00am-5:00pm EST

Company information

SPL UNCLASSIFIED SECTION

Distributed in USA by

Expanscience Laboratories

dba Mustela, New York, NY 10022, USA

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z2
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z2
4,4-DIMETHYLOXAZOLIDINEINACTIVE INGREDIENT96J42P99ZA2
AVOCADOINACTIVE INGREDIENTSDS87L369F2
AVOCADO OILINACTIVE INGREDIENT6VNO72PFC12
CAPRYLOYL GLYCINEINACTIVE INGREDIENT8TY5YO42NJ2
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U2
COCO-CAPRYLATE/CAPRATEINACTIVE INGREDIENT8D9H4QU99H2
ETHYL LINOLENATEINACTIVE INGREDIENTT54Y8H042V2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
LEVULINIC ACIDINACTIVE INGREDIENTRYX5QG61EI2
MAGNESIUM SULFATEINACTIVE INGREDIENTDE08037SAB2
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U2
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATEINACTIVE INGREDIENT9229XJ4V122
POLYGLYCERYL-3 DIISOSTEARATEINACTIVE INGREDIENT46P231IQV82
PROPYLENE CARBONATEINACTIVE INGREDIENT8D08K3S51E2
SODIUM LEVULINATEINACTIVE INGREDIENTVK44E1MQU82
STEARALKONIUM HECTORITEINACTIVE INGREDIENTOLX698AH5P2
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YI2
WATERINACTIVE INGREDIENT059QF0KO0R2
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2V2

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64768-292264768-2922-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
SUNFLOWER OIL3W1JG795YIIACT
LEVULINIC ACIDRYX5QG61EIIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
AVOCADOSDS87L369FIACT
AVOCADO OIL6VNO72PFC1IACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
PROPYLENE CARBONATE8D08K3S51EIACT
SODIUM LEVULINATEVK44E1MQU8IACT
STEARALKONIUM HECTORITEOLX698AH5PIACT
4,4-DIMETHYLOXAZOLIDINE96J42P99ZAIACT
WATER059QF0KO0RIACT
YELLOW WAX2ZA36H0S2VIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CAPRYLOYL GLYCINE8TY5YO42NJIACT
CAPRYLYL GLYCOL00YIU5438UIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
ETHYL LINOLEATEMJ2YTT4J8MIACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82026-08-20daily-update2026-08-22 01:01:00
72024-12-02full-release2026-06-01 00:39:59

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 16 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MAGNESIUM SULFATEMAGNESIUM SULFATEDE08037SABSOAP / TOPICAL0.2 %w/wExact identifier — unii+route
2 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCREAM / TOPICAL3300 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
COCO-CAPRYLATE/CAPRATECOCOYL CAPRYLOCAPRATE8D9H4QU99HGEL / TOPICAL2.5 %w/wExact identifier — unii+route
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE CARBONATEPROPYLENE CARBONATE8D08K3S51EOINTMENT / TOPICAL3000 mgExact identifier — unii+route
2 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCREAM / TOPICAL5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCREAM / TOPICAL3300 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
COCO-CAPRYLATE/CAPRATECOCOYL CAPRYLOCAPRATE8D9H4QU99HGEL / TOPICAL2.5 %w/wExact identifier — unii+route
2 equally ranked IID candidates
MAGNESIUM SULFATEMAGNESIUM SULFATEDE08037SABSOAP / TOPICAL0.2 %w/wExact identifier — unii+route
2 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCREAM / TOPICAL5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LEVULINIC ACIDLEVULINIC ACIDRYX5QG61EISYSTEM / TRANSDERMAL20 mgExact identifier — unii candidate
4 equally ranked IID candidates
LEVULINIC ACIDLEVULINIC ACIDRYX5QG61EISYSTEM / TRANSDERMAL20 mgExact identifier — unii candidate
4 equally ranked IID candidates
LEVULINIC ACIDLEVULINIC ACIDRYX5QG61EIFILM, EXTENDED RELEASE / TRANSDERMAL16.5 mgExact identifier — unii candidate
4 equally ranked IID candidates
LEVULINIC ACIDLEVULINIC ACIDRYX5QG61EIFILM, EXTENDED RELEASE / TRANSDERMAL16.5 mgExact identifier — unii candidate
4 equally ranked IID candidates
PROPYLENE CARBONATEPROPYLENE CARBONATE8D08K3S51EOINTMENT / TOPICAL3000 mgExact identifier — unii+route
2 equally ranked IID candidates

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
MUSTELA Diaper Rash 1 2 3ZINC OXIDEExpanscience Laboratories d/b/a Mustela163f388e-849d-4b7e-93c1-9045d77a9ec22026-08-21WarningsExact identifier
ndc (package): 64768-2922-1
ndc (product): 64768-2922
ndc11 (package): 64768292201
spl id: 5995d8e5-7e8b-eec5-e063-6394a90ab31b
spl set id: 163f388e-849d-4b7e-93c1-9045d77a9ec2

Reported adverse events (FAERS/openFDA)#

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