FDA.reportPublic FDA data

Mustela Diaper Rash Sprayable Cream

Manufacturer
Expanscience Laboratories d/b/a Mustela
Effective date
2024-12-02
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:40:12

Label at a glance#

ProductMustela Diaper Rash Sprayable
Active ingredientZINC OXIDE
Label structure8 sections

Indications and uses

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

Dosage and administration

Shake well before use. Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Spray 4-6 inches from skin. Spray product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged. No need to rub in.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (Non-Nano) 14.9%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Helps treat and prevent diaper rash
  • Protects minor skin irritation 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 or symptoms last more than 7 days or 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

  • Shake well before use.
  • Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry.
  • Spray 4-6 inches from skin.
  • Spray product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
  • No need to rub in.

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER (AQUA), OLEA EUROPAEA (OLIVE) FRUIT OIL, PROPANEDIOL, RICINUS COMMUNIS (CASTOR) SEED OIL, BENTONITE, GLYCERYL ROSINATE, CETEARYL ALCOHOL, CALENDULA OFFICINALIS FLOWER EXTRACT*, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT*, PERSEA GRATISSIMA (AVOCADO) FRUIT EXTRACT, ALOE BARBADENSIS LEAF JUICE*, BUTYROSPERMUM PARKII (SHEA) BUTTER*, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL*, OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES, GLYCERIN, GLYCERYL OLEATE, COCO-GLUCOSIDE, MICROCRYSTALLINE CELLULOSE, CELLULOSE GUM, CAPRYLHYDROXAMIC ACID, CAPRYLYL GLYCOL

*Certified Organic Ingredients

Company information

SPL UNCLASSIFIED SECTION

MADE IN THE USA from globally sourced materials for Expanscience Laboratories Inc., Dba Mustela, 60 E. 56th St. 6th Floor, New York, New York 10022 www.MustelaUSA.com For sale only through select retailers.

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2595464zinc oxide 14.9 % Topical SprayPSN4
2595464zinc oxide 149 MG/ML Topical SpraySCD4
2595464zinc oxide 14.9 % Topical SpraySY4
2595464ZNO 149 MG/ML Topical SpraySY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64768-2928-1Mustela Diaper Rash Sprayable88 mL in 1 BOTTLE, SPRAYCREAM884

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64768-2928MUSTELA DIAPER RASH SPRAYABLE (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]4Current NDC, Legacy NDC, 1 package rows20241204_d9a2aaf6-ab71-97a3-e053-2a95a90a3498.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64768-292864768-2928-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENTONITEA3N5ZCN45CIACT
CHAMOMILEFGL3685T2XIACT
COCO GLUCOSIDEICS790225BIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
OLIVE OIL6UYK2W1W1EIACT
PROPANEDIOL5965N8W85TIACT
CASTOR OILD5340Y2I9GIACT
GLYCERYL ROSINATESD112V492JIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
CAPRYLYL GLYCOL00YIU5438UIACT
GLYCERYL OLEATE4PC054V79PIACT
GLYCERINPDC6A3C0OXIACT
SUNFLOWER OIL3W1JG795YIIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
AVOCADOSDS87L369FIACT
ALOE VERA LEAFZY81Z83H0XIACT
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLESXO45V955LTIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
SHEA BUTTERK49155WL9YIACT
WATER059QF0KO0RIACT
ZINC OXIDESOI2LOH54ZACTIB

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
Mustela Diaper Rash SprayableZINC OXIDEExpanscience Laboratories d/b/a Mustelad9a2aaf6-ab71-97a3-e053-2a95a90a34982024-12-02WarningsExact identifier
ndc (package): 64768-2928-1
ndc (product): 64768-2928
ndc11 (package): 64768292801
spl id: 284b31ef-6e4d-af01-e063-6394a90ae06e
spl set id: d9a2aaf6-ab71-97a3-e053-2a95a90a3498

Reported adverse events (FAERS/openFDA)#

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