FDA.reportPublic FDA data

Johnsons Baby Care Essentials Gift Set

Manufacturer
Kenvue Brands LLC
Effective date
2025-11-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:18:48

Label at a glance#

ProductJohnsons Baby Care Essentials Gift Set
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 paste 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°C to 25°C (68°F to 77°F) • may stain clothing

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DESITIN Maximum Strength Zinc Oxide Diaper Rash

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (40%)

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

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

• allow to dry

• apply paste 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°C to 25°C (68°F to 77°F)

• may stain clothing

Inactive ingredients

INACTIVE INGREDIENT SECTION

Petrolatum, Cod Liver Oil, Lanolin, Zea Mays (Corn) Starch, Glycerin, Beeswax, Sorbitan Sesquioleate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Tocopheryl Acetate, Fragrance

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 - Kit Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Johnson’s®

baby

baby care essentials

value

pack

all products are

TSA compliant!

Includes

JOHNSON’S® baby lotion 3.4 FL OZ (100 mL)

JOHNSON’S ® baby HEAD-TO-TOE ® wash & shampoo 3.4 FL OZ (100 mL)

DESITIN ® Maximum Strength 40% Zinc Oxide Diaper Rash Ointment 1 OZ (28 g).

A selection of gentle products to cleanse, moisturize, and care for baby’s delicate skin

JohnsonsJohnsons

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1797059Desitin 40 % Topical PastePSN1
1094560zinc oxide 40 % Topical PastePSN1
1797059zinc oxide 0.4 MG/MG Paste [Desitin]SBD1
1094560zinc oxide 0.4 MG/MG PasteSCD1
1797059Desitin 40 % Topical PasteSY1
1094560zinc oxide 40 % PasteSY1
1094560ZNO 0.4 MG/MG PasteSY1
1797059ZNO 0.4 MG/MG Paste [Desitin]SY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130381371197569GTIN-13: 0381371197569
EAN-13: 0381371197569
GTIN-12: 381371197569
UPC-A: 381371197569
GTIN storage (14 digits): 00381371197569		Johnsons_1.jpg
Data codeData Matrix30060909Johnsons_1.jpg
Data codeData Matrix30061828Johnsons_1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0848-9Johnsons Baby Care Essentials Gift Set1 in 1 CARTONPASTE400 mg in 1g1
69968-0848-9Johnsons Baby Care Essentials Gift Set28 g in 1 TUBEPASTE28 g400 mg in 1g1
69968-0953-9Johnsons Baby Care Essentials Gift Set1 in 1 PACKAGEKIT11

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-095369968-0953-9
69968-084869968-0848-9

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)255PIF62MSIACT
PETROLATUM4T6H12BN9UIACT
COD LIVER OILBBL281NWFGIACT
LANOLIN7EV65EAW6HIACT
ZEA MAYS (CORN) STARCHO8232NY3SJIACT
GLYCERINPDC6A3C0OXIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
BEESWAX2ZA36H0S2VIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RINGR
COCAMIDOPROPYL BETAINE5OCF3O11KXINGR
PEG-80 SORBITAN LAURATE239B50Y732INGR
GLYCERINPDC6A3C0OXINGR
PEG-150 PENTAERYTHRITYL TETRASTEARATE8L4OOQ76AMINGR
PPG-2 HYDROXYETHYL COCAMIDE34N07GUJ3XINGR
PHENOXYETHANOLHIE492ZZ3TINGR
SODIUM METHYL COCOYL TAURATEJVL98CG53GINGR
SODIUM BENZOATEOJ245FE5EUINGR
DECYL GLUCOSIDEZ17H97EA6YINGR
CITRIC ACID2968PHW8QPINGR
ETHYLHEXYLGLYCERIN147D247K3PINGR
ALOE BARBADENSIS LEAFZY81Z83H0XINGR
PANTHENOLWV9CM0O67ZINGR
CAPRYLYL GLYCOL00YIU5438UINGR
PHENOXYETHANOLHIE492ZZ3TINGR
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COINGR
SODIUM HYDROXIDE55X04QC32IINGR
ALOE BARBADENSIS LEAFZY81Z83H0XINGR
WATER059QF0KO0RINGR
GLYCERINPDC6A3C0OXINGR
ISOPROPYL MYRISTATE0RE8K4LNJSINGR
CETYL ALCOHOL936JST6JCNINGR
COCOS NUCIFERA (COCONUT) OILQ9L0O73W7LINGR
PANTHENOLWV9CM0O67ZINGR
POTASSIUM CETYL PHOSPHATE03KCY6P7UTINGR

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Johnsons Baby Care Essentials Gift SetZINC OXIDEKenvue Brands LLC43edc287-57e1-d96e-e063-6294a90ac5a12025-11-24WarningsExact identifier
ndc (package): 69968-0848-9
ndc (package): 69968-0953-9
ndc (product): 69968-0953
ndc11 (package): 69968095309
ndc11 (package): 69968084809
spl id: 43edc298-39da-5eb5-e063-6394a90a134e
spl set id: 43edc287-57e1-d96e-e063-6294a90ac5a1
Desitin Maximum Strength Zinc Oxide Diaper RashZINC OXIDEKenvue Brands LLC1590101a-c968-fca5-e063-6394a90a7ccc2025-02-28WarningsExact identifier
ndc (package): 69968-0848-9
ndc (product): 69968-0848
ndc11 (package): 69968084809
Johnsons Baby Care Essentials Gift SetZINC OXIDEKenvue Brands LLC1ac59efd-9efd-09d9-e063-6394a90a5e402025-01-20WarningsExact identifier
ndc (package): 69968-0848-9
ndc11 (package): 69968084809

Reported adverse events (FAERS/openFDA)#

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