FDA.reportPublic FDA data

Johnsons Bath Discovery Baby Gift Set

Manufacturer
Johnson & Johnson Consumer Inc.
Effective date
2023-05-02
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:31:58

Label at a glance#

ProductJohnsons Bath Discovery 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 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

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

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 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, Talc, Glycerin, Sorbitan Sesquioleate, Beeswax, Tocopheryl Acetate, Fragrance

Questions?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - Kit Tray

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bath
discovery ®
baby gift set
set de regalo para bebés descubramos el baño
no parabens, phthalates, sulfates or dyes

more than
getting clean,
it's time to
play and learn

JOHNSON'S ®

JOHNSON'S ® baby lotion 10.2 FL OZ (300mL) • JOHNSON'S ® HEAD-TO TOE ® wash and shampoo 10.2 FL OZ (300 mL) • JOHNSON'S ® baby shampoo 6.8 FL OZ (200 mL)
JOHNSON'S ® COTTONTOUCH™ newborn face & body lotion 1.7 FL OZ (50 mL) • JOHNSON'S ® hand & face wipes 25 Ct. 7.5 × 3in. (190×185cm)
JOHNSON'S ® safety swabs 55 ct • DESITIN ® Maximum Strength Zinc Oxide Diaper Rash Paste 2 OZ (57 g)

PRINCIPAL DISPLAY PANEL - Kit Tray
PRINCIPAL DISPLAY PANEL - Kit Tray

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69968-0061-1GM - Gram69968-0061f10dbdb2-0d9b-41ce-b70a-58f111649b9f12021-06-02

Products#

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

DailyMed product names page 1 of 2 · 53 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-054969968-0549-1
69968-006169968-0061-2

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 72 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UIACT
COD LIVER OILBBL281NWFGIACT
LANOLIN7EV65EAW6HIACT
TALC7SEV7J4R1UIACT
GLYCERINPDC6A3C0OXIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
YELLOW WAX2ZA36H0S2VIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RINGR
GLYCERINPDC6A3C0OXINGR
ISOPROPYL PALMITATE8CRQ2TH63MINGR
STEARIC ACID4ELV7Z65APINGR
GLYCERYL MONOSTEARATE230OU9XXE4INGR
CETYL ALCOHOL936JST6JCNINGR
COCONUT OILQ9L0O73W7LINGR
DIMETHICONE92RU3N3Y1OINGR
CETOSTEARYL ALCOHOL2DMT128M1SINGR
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
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

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 Maximum Strength Diaper RashZINC OXIDEKenvue Brands LLCaf64fc2f-c027-4a68-b368-ee06744a24522024-11-15WarningsExact identifier
ndc (package): 69968-0061-2
ndc (product): 69968-0061
ndc11 (package): 69968006102
fab5261a-48a0-8725-e053-6394a90ae729e4e25f5e-da78-48b0-b5c7-74d2aba578372023-05-02WarningsExact identifier
spl id: fab5261a-48a0-8725-e053-6394a90ae729
spl set id: e4e25f5e-da78-48b0-b5c7-74d2aba57837

Reported adverse events (FAERS/openFDA)#

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