FDA.reportPublic FDA data

Johnsons Baby Care Essentials Gift Set

Manufacturer
Kenvue Brands LLC
Effective date
2025-01-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:53:26

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® HEAD-TO-TOE® wash & shampoo 3.4 FL OZ (100 mL)

DESITIN® Maximum Strength Zinc Oxide Diaper Rash Paste 1 OZ (28 g).

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

Johnsons_01Johnsons_01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1797059Desitin 40 % Topical PastePSN3
1094560zinc oxide 40 % Topical PastePSN3
1797059zinc oxide 0.4 MG/MG Paste [Desitin]SBD3
1094560zinc oxide 0.4 MG/MG PasteSCD3
1797059Desitin 40 % Topical PasteSY3
1094560zinc oxide 40 % PasteSY3
1094560ZNO 0.4 MG/MG PasteSY3
1797059ZNO 0.4 MG/MG Paste [Desitin]SY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0848-9Johnsons Baby Care Essentials Gift Set1 in 1 CARTONPASTE400 mg in 1g3
69968-0848-9Johnsons Baby Care Essentials Gift Set28 g in 1 TUBEPASTE28 g400 mg in 1g3
69968-0894-9Johnsons Baby Care Essentials Gift Set1 in 1 PACKAGEKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0848JOHNSONS BABY CARE ESSENTIALS GIFT SET (ZINC OXIDE) KIT [KENVUE BRANDS LLC]3Current NDC20250124_1ac59efd-9efd-09d9-e063-6394a90a5e40.zip
69968-0894JOHNSONS BABY CARE ESSENTIALS GIFT SET (ZINC OXIDE) KIT [KENVUE BRANDS LLC]3Current NDC, 3 package rows20250124_1ac59efd-9efd-09d9-e063-6394a90a5e40.zip

Products#

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

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-089469968-0894-9
69968-084869968-0848-9

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Name, UNII, Kind table
NameUNIIKind
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)255PIF62MSIACT
PETROLATUM4T6H12BN9UIACT
COD LIVER OILBBL281NWFGIACT
LANOLIN7EV65EAW6HIACT
STARCH, CORNO8232NY3SJIACT
GLYCERINPDC6A3C0OXIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
YELLOW WAX2ZA36H0S2VIACT
.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 ACID MONOHYDRATE2968PHW8QPINGR
ETHYLHEXYLGLYCERIN147D247K3PINGR
PHENOXYETHANOLHIE492ZZ3TINGR
POLYSORBATE 207T1F30V5YHINGR
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCINGR
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COINGR
P-ANISIC ACID4SB6Y7DMM3INGR
SODIUM HYDROXIDE55X04QC32IINGR
XANTHAN GUMTTV12P4NEEINGR
ETHYLHEXYLGLYCERIN147D247K3PINGR
TITANIUM DIOXIDE15FIX9V2JPINGR
WATER059QF0KO0RINGR
GLYCERINPDC6A3C0OXINGR
ISOPROPYL PALMITATE8CRQ2TH63MINGR
STEARIC ACID4ELV7Z65APINGR
GLYCERYL MONOSTEARATE230OU9XXE4INGR
CETYL ALCOHOL936JST6JCNINGR
COCONUT OILQ9L0O73W7LINGR
CETOSTEARYL ALCOHOL2DMT128M1SINGR

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
ndc11 (package): 69968084809
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
ndc (package): 69968-0894-9
ndc (product): 69968-0894
ndc11 (package): 69968089409
ndc11 (package): 69968084809
spl id: 2c23de94-80b2-6435-e063-6394a90a3df5
spl set id: 1ac59efd-9efd-09d9-e063-6394a90a5e40

Reported adverse events (FAERS/openFDA)#

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