FDA.reportPublic FDA data

Johnsons Welcome Baby Gift Set

Manufacturer
Johnson & Johnson Consumer Inc.
Effective date
2023-03-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:34:29

Label at a glance#

ProductJohnsons Welcome 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° to 25°C (68°F to 77°F) may stain clothing

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DESITIN ® Daily Defense Zinc Oxide Diaper Rash Cream

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)
  • 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)

For more information on preventing and treating diaper rash, visit www.desitin.com

SPL UNCLASSIFIED SECTION

Distributed by: JOHNSON & JOHNSON CONSUMER
INC. Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - Kit Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

JOHNSON'S ®
welcome baby
gift set
set de regalo de bienvenida para bebé

SAFETY TESTED
FOR DELICATE SKIN

INCLUDES: JOHNSON'S ® COTTONTOUCH® NEWBORN WASH & SHAMPOO 13.6 FL OZ (400 mL) ● JOHNSON'S ®
HAND & FACE WIPES 25 CT 7.5 × 7.3 IN (190 × 185 MM) ● JOHNSON'S ® COTTONTOUCH ® NEWBORN FACE &
BODY LOTION 13.6 FL OZ (400 mL) ● DESITIN ® DAILY DEFENSE DIAPER RASH CREAM 2 OZ (57 G)

Principal Display Panel - Kit Package
Principal Display Panel - Kit Package

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 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-071269968-0712-9
69968-060369968-0603-2

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 52 matching rows.

Name, UNII, Kind table
NameUNIIKind
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CAPRYLYL GLYCOL00YIU5438UIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
YELLOW WAX2ZA36H0S2VIACT
DIMETHICONE92RU3N3Y1OIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW)9713Q0S7FOIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
TROPOLONE7L6DL16P1TIACT
WATER059QF0KO0RINGR
COCAMIDOPROPYL BETAINE5OCF3O11KXINGR
PEG-80 SORBITAN LAURATE239B50Y732INGR
DECYL GLUCOSIDEZ17H97EA6YINGR
COTTON FIBER70LDW53ROOINGR
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COINGR
PHENOXYETHANOLHIE492ZZ3TINGR
SODIUM BENZOATEOJ245FE5EUINGR
COCO GLUCOSIDEICS790225BINGR
GLYCERYL MONOOLEATEC4YAD5F5G6INGR
SODIUM HYDROXIDE55X04QC32IINGR
ETHYLHEXYLGLYCERIN147D247K3PINGR
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYINGR
ISOPROPYL PALMITATE8CRQ2TH63MINGR
WATER059QF0KO0RINGR
GLYCERINPDC6A3C0OXINGR
COTTON FIBER70LDW53ROOINGR
DIMETHICONE92RU3N3Y1OINGR
PHENOXYETHANOLHIE492ZZ3TINGR
CETEARYL OLIVATE58B69Q84JOINGR
SORBITAN OLIVATEMDL271E3GRINGR
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COINGR

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
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): 69968-0603-2
ndc11 (package): 69968060302
f6d82443-7579-bc58-e053-6394a90a5ed2a0c8fe00-f6c2-4df9-8b75-3110ffd2bb982023-03-14WarningsExact identifier
spl id: f6d82443-7579-bc58-e053-6394a90a5ed2
spl set id: a0c8fe00-f6c2-4df9-8b75-3110ffd2bb98

Reported adverse events (FAERS/openFDA)#

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