FDA.reportPublic FDA data

Earth Baby Diaper Rash Cream

Manufacturer
Earth Baby, Inc | KDC/ONE SOCAL LABORATORIES, LLC
Effective date
2026-06-28
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
monthly-update
Hydrated at
2026-07-17 21:37:14

Label at a glance#

ProductEarth Baby Diaper Rash Cream
Active ingredientZINC OXIDE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient
Zinc Oxide 40%

OTC - PURPOSE SECTION


Skin Protectant

WARNINGS SECTION

Warnings
For external use only.

OTC - WHEN USING SECTION

When using this product Do not get into eyes

OTC - STOP USE SECTION

Stop use and ask a doctor if
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.

DOSAGE & ADMINISTRATION SECTION

Directions
Change diaper promptly.
Clean diaper area, allow to dry
Apply a generous amount of creamwith each diaper change and before bedtime.

OTHER SAFETY INFORMATION

Other information
Store at 20° - 25°C (68° to 77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients:
Avena Sativa (Oat) Kernel Protein, Aloe Barbadensis Leaf Juice*, Aqua/Water, Beeswax, Canola Oil, Carthamus Tinctorius (Safflower) Oleosomes*, Caryodendron Orinocense (Kahai) Seed Oil, Cucurbita Pepo (Pumpkin) Extract, Glycerin, Lavandula Intermedia (Lavender) Flower/Leaf/Stem Extract*, Locinera Japonica (Honeysuckle) Flower Extract, Lonicera Caprifolium (Honeysuckle) Extract, Parfum/Natural Fragrance, Silica, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hyaluronate, Tocopheryl Acetate (Vitamin E), Zea Mays (Corn) Starch.

INDICATIONS & USAGE SECTION

Helps protect against diaper rash and irritation.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRCDRC

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62588-90462588-904-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
ALOEV5VD430YW9IACT
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES9S60Q72309IACT
CARYODENDRON ORINOCENSE WHOLEJ2T2D81BHUIACT
CUCURBITA PEPO WHOLE48V44WX64IIACT
GLYCERINPDC6A3C0OXIACT
LAVANDULA X INTERMEDIA WHOLE9Q3NSN290FIACT
LONICERA CAPRIFOLIUM WHOLE4F67A99YTFIACT
OAT KERNEL OIL3UVP41R77RIACT
HYALURONATE SODIUMYSE9PPT4THIACT
LONICERA JAPONICA FLOWER4465L2WS4YIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
JOJOBA OIL724GKU717MIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
CANOLA OIL331KBJ17RKIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52025-05-06full-release2026-06-01 01:00:27

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Earth Baby Diaper Rash CreamZINC OXIDEEarth Baby, Inc42c5cf9a-0a35-5681-e054-00144ff8d46c2026-06-28WarningsExact identifier
ndc (package): 62588-904-02
ndc (product): 62588-904
ndc11 (package): 62588090402
spl id: 55584e70-5cf6-2a4d-e063-6394a90aae22
spl set id: 42c5cf9a-0a35-5681-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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