FDA.reportPublic FDA data

Johnsons First Touch Baby Gift Set

Manufacturer
Kenvue Brands LLC
Effective date
2024-11-25
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:39:29

Label at a glance#

ProductJohnsons First Touch Baby 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 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°C 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°C 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) or visit www.desitin.com

SPL UNCLASSIFIED SECTION

Distributed by:

JOHNSON & JOHNSON

CONSUMER INC.

Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - Kit Bag

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Johnson’s ®

first touch

baby gift set

a selection of gentle products to cleanse, moisturize,

and care for baby’s delicate skin and hair

hypoallergenic, no parabens, phthalates, or dyes

Includes: JOHNSON’S ® head-to-toe ® wash & shampoo 13.6 FL OZ (400mL), JOHNSON’S ® baby lotion 13.6 FL OZ (400mL),

DESITIN ® daily defense zinc oxide diaper rash cream 2OZ (57 g), 1 recyclable storage caddy with handle

Johnsons_01Johnsons_01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1090577Desitin 13 % Topical CreamPSN5
349404zinc oxide 13 % Topical CreamPSN5
1090577zinc oxide 130 MG/ML Topical Cream [Desitin]SBD5
349404zinc oxide 130 MG/ML Topical CreamSCD5
1090577Desitin 130 MG/ML Topical CreamSY5
1090577Desitin Rapid Relief 13 % Topical CreamSY5
349404zinc oxide 13 % Topical CreamSY5
349404ZNO 130 MG/ML Topical CreamSY5
1090577ZNO 130 MG/ML Topical Cream [Desitin]SY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69968-0739-92024-01-30C16284748780-11030e365-4358-111a-e063-dadaa90a10e2Johnson’s® first touch baby gift set Desitin® Daily Defense Zinc Oxide Diaper Rash Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0603-2Johnsons First Touch Baby Gift Set57 g in 1 TUBECREAM57 g130 mg in 1g5
69968-0603-2Johnsons First Touch Baby Gift Set1 in 1 CARTONCREAM130 mg in 1g5
69968-0739-9Johnsons First Touch Baby Gift Set1 in 1 BAGKIT15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0603JOHNSONS FIRST TOUCH BABY GIFT SET (ZINC OXIDE) KIT [KENVUE BRANDS LLC]5Current NDC, Legacy NDC20241127_da5469ea-3330-4f04-e053-2a95a90aff41.zip
69968-0739JOHNSONS FIRST TOUCH BABY GIFT SET (ZINC OXIDE) KIT [KENVUE BRANDS LLC]5Current NDC, Legacy NDC, 3 package rows20241127_da5469ea-3330-4f04-e053-2a95a90aff41.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 2 · 44 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-073969968-0739-9
69968-060369968-0603-2

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 47 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
GLYCERINPDC6A3C0OXIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CAPRYLYL GLYCOL00YIU5438UIACT
MAGNESIUM SULFATE, UNSPECIFIEDDE08037SABIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
PHENOXYETHANOLHIE492ZZ3TIACT
MINERAL OILT5L8T28FGPIACT
YELLOW WAX2ZA36H0S2VIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
WATER059QF0KO0RIACT
PETROLATUM4T6H12BN9UIACT
DIMETHICONE92RU3N3Y1OIACT
PEG-30 DIPOLYHYDROXYSTEARATE9713Q0S7FOIACT
ALOE VERA LEAFZY81Z83H0XIACT
TROPOLONE7L6DL16P1TIACT
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
WATER059QF0KO0RINGR
GLYCERINPDC6A3C0OXINGR
ISOPROPYL PALMITATE8CRQ2TH63MINGR
STEARIC ACID4ELV7Z65APINGR
GLYCERYL MONOSTEARATE230OU9XXE4INGR
CETYL ALCOHOL936JST6JCNINGR
COCONUT OILQ9L0O73W7LINGR
CETOSTEARYL ALCOHOL2DMT128M1SINGR
PHENOXYETHANOLHIE492ZZ3TINGR
POLYSORBATE 207T1F30V5YHINGR

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): 69968-0603-2
ndc (product): 69968-0603
ndc11 (package): 69968060302
Johnsons First Touch Baby Gift SetZINC OXIDEKenvue Brands LLCda5469ea-3330-4f04-e053-2a95a90aff412024-11-25WarningsExact identifier
ndc (package): 69968-0739-9
ndc (package): 69968-0603-2
ndc (product): 69968-0739
ndc11 (package): 69968060302
ndc11 (package): 69968073909
spl id: 22de1d57-9566-cec9-e063-6394a90ac8a5
spl set id: da5469ea-3330-4f04-e053-2a95a90aff41

Reported adverse events (FAERS/openFDA)#

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