FDA.reportPublic FDA data

Desitin ® Daily Defense Zinc Oxide Diaper Rash Cream

Manufacturer
Kenvue Brands LLC
Effective date
2024-12-11
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:43:31

Label at a glance#

ProductDesitin Daily Defense Zinc Oxide Diaper Rash
Active ingredientZINC OXIDE
Label structure11 sections

Indications and uses

helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps seal out wetness

Dosage and administration

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

Storage and handling

store at 20° to 25°C (68°F to 77°F) protect from freezing may stain clothing

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 13%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and 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 7 days or clear up and occur again within a few days

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

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

Other Information

STORAGE AND HANDLING SECTION

  • store at 20° to 25°C (68°F to 77°F)
  • protect from freezing
  • may stain clothing

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, mineral oil, petrolatum, beeswax, dimethicone, sorbitan sesquioleate, microcrystalline wax, PEG-30 dipolyhydroxystearate, aloe barbadensis leaf extract, glycerin, tropolone, tocopheryl acetate, 1,2-hexanediol, caprylyl glycol, magnesium sulfate, potassium hydroxide, phenoxyethanol

Questions?

OTC - QUESTIONS SECTION

Call toll-free 800-720-3843 or 215-273-8755 (collect)

SPL UNCLASSIFIED SECTION

Distributed by:
Kenvue Brands LLC
Summit, NJ 07901

PRINCIPAL DISPLAY PANEL - 136 g Jar Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1

CHOICE

OF PEDIATRICIANS & PARENTS

Desitin ®

Daily Defense

13% Zinc Oxide Diaper Rash Cream

protects against diaper

rash from the first use

Free from parabens, phthalates, dyes and fragrance,

Hypoallergic • Pediatrician & Dermatologist tested

NET WT 4.8 Oz (136 g)

Desitin_1Desitin_1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1090577Desitin 13 % Topical CreamPSN6
349404zinc oxide 13 % Topical CreamPSN6
1090577zinc oxide 130 MG/ML Topical Cream [Desitin]SBD6
349404zinc oxide 130 MG/ML Topical CreamSCD6
1090577Desitin 130 MG/ML Topical CreamSY6
1090577Desitin Rapid Relief 13 % Topical CreamSY6
349404zinc oxide 13 % Topical CreamSY6
349404ZNO 130 MG/ML Topical CreamSY6
1090577ZNO 130 MG/ML Topical Cream [Desitin]SY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69968-0603-12024-11-25C16284748780-11e7a6dab-1ac6-a2ce-e063-dadaa90aadf7Desitin ® Daily Defense Zinc Oxide Diaper Rash Cream
69968-0603-22024-11-25C16284748780-11e7a6dab-1ac6-a2ce-e063-dadaa90aadf7Desitin ® Daily Defense Zinc Oxide Diaper Rash Cream
69968-0603-42024-11-25C16284748780-11e7a6dab-1ac6-a2ce-e063-dadaa90aadf7Desitin ® Daily Defense Zinc Oxide Diaper Rash Cream
69968-0603-52024-11-25C16284748780-11e7a6dab-1ac6-a2ce-e063-dadaa90aadf7Desitin ® Daily Defense Zinc Oxide Diaper Rash Cream
69968-0603-12024-07-30C16284748780-11e7a6dab-1ac6-a2ce-e063-dadaa90aadf7Desitin ® Daily Defense Zinc Oxide Diaper Rash Cream
69968-0603-22024-07-30C16284748780-11e7a6dab-1ac6-a2ce-e063-dadaa90aadf7Desitin ® Daily Defense Zinc Oxide Diaper Rash Cream
69968-0603-42024-07-30C16284748780-11e7a6dab-1ac6-a2ce-e063-dadaa90aadf7Desitin ® Daily Defense Zinc Oxide Diaper Rash Cream
69968-0603-52024-07-30C16284748780-11e7a6dab-1ac6-a2ce-e063-dadaa90aadf7Desitin ® Daily Defense Zinc Oxide Diaper Rash Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0603-1Desitin Daily Defense Zinc Oxide Diaper Rash454 g in 1 JARCREAM4546
69968-0603-2Desitin Daily Defense Zinc Oxide Diaper Rash57 g in 1 TUBECREAM576
69968-0603-2Desitin Daily Defense Zinc Oxide Diaper Rash1 in 1 CARTONCREAM16
69968-0603-4Desitin Daily Defense Zinc Oxide Diaper Rash1 in 1 CARTONCREAM16
69968-0603-4Desitin Daily Defense Zinc Oxide Diaper Rash113 g in 1 TUBECREAM1136
69968-0603-5Desitin Daily Defense Zinc Oxide Diaper Rash136 g in 1 TUBECREAM1366
69968-0603-5Desitin Daily Defense Zinc Oxide Diaper Rash1 in 1 CARTONCREAM16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0603DESITIN DAILY DEFENSE ZINC OXIDE DIAPER RASH (ZINC OXIDE) CREAM [KENVUE BRANDS LLC]6Current NDC, Legacy NDC, 7 package rows20241215_b6e0d1a3-e469-4102-916b-d5cc8ca12e73.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69968-0603-1GM - Gram69968-06036781e7cd-61c3-4750-bf43-e19396cc70fe12022-06-06

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-060369968-0603-2, 69968-0603-4, 69968-0603-5, 69968-0603-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
YELLOW WAX2ZA36H0S2VIACT
DIMETHICONE92RU3N3Y1OIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW)9713Q0S7FOIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
TROPOLONE7L6DL16P1TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CAPRYLYL GLYCOL00YIU5438UIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
PHENOXYETHANOLHIE492ZZ3TIACT
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Desitin Daily Defense Zinc Oxide Diaper RashZINC OXIDEKenvue Brands LLCb6e0d1a3-e469-4102-916b-d5cc8ca12e732024-12-11WarningsExact identifier
ndc (package): 69968-0603-1
ndc (package): 69968-0603-2
ndc (package): 69968-0603-5
ndc (package): 69968-0603-4
ndc (product): 69968-0603
ndc11 (package): 69968060301
ndc11 (package): 69968060302
ndc11 (package): 69968060304
ndc11 (package): 69968060305
spl id: 28fd6f2e-9783-5064-e063-6394a90a6fc0
spl set id: b6e0d1a3-e469-4102-916b-d5cc8ca12e73
Johnsons First Touch Baby Gift SetZINC OXIDEKenvue Brands LLCda5469ea-3330-4f04-e053-2a95a90aff412024-11-25WarningsExact identifier
ndc (package): 69968-0603-2
ndc11 (package): 69968060302

Reported adverse events (FAERS/openFDA)#

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