FDA.reportPublic FDA data

Babo Botanicals Sensitive Baby Fragrance Free Diaper Cream

Manufacturer
Royal Labs Natural Cosmetics, Inc. | Royal Labs Natural Cosmetics, Inc
Effective date
2021-01-27
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
legacy-cache
Hydrated at
2026-08-01 22:54:31

Label at a glance#

ProductBabo Botanicals Sensitive Baby Fragrance Free Diaper Cream
Active ingredientZINC OXIDE
Label structure11 sections

Indications and uses

Helps treat and prevent diaper rash Protects chafed skin and minor irritation associated with diaper rash Helps seal out wetness

Dosage and administration

Change wet and soiled diapers promptly. Cleanse the diaper area and allow to dry. Apply cream liberally and as often as necessary with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Helps treat and prevent diaper rash

Protects chafed skin and minor irritation associated with diaper rash

Helps seal out wetness

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

Avoid contact with eyes

Stop use and ask doctor if

OTC - STOP USE SECTION

Conditions worsen

symptoms last more than seven days

symptoms 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

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 25% Purpose: Skin Protectant

Inactive Ingredients

INACTIVE INGREDIENT SECTION

BUTYROSPERMUM PARKII (SHEA) BUTTER, CALENDULA OFFICINALIS FLOWER EXTRACT*, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT*, COCOS NUCIFERA (COCONUT) OIL, EUPHORBIA CERIFERA (CANDELILLA) WAX, GLYCERIN*, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL , HYDROGENATED VEGETABLE OIL, LECITHIN, NASTURTIUM OFFICINALE (WATERCRESS) FLOWER/LEAF EXTRACT*, ROSMARINUS OFFICINALIS (ROSEMARY) EXTRACT, SPIRAEA ULMARIA (MEADOWSWEET) FLOWER EXTRACT*, THEOBROMA CACAO (COCOA) SEED BUTTER. *Certified Organic Ingredients

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun. You may report an adverse reaction to to the phone number or address provided below.

DIrections

DOSAGE & ADMINISTRATION SECTION

Change wet and soiled diapers promptly. Cleanse the diaper area and allow to dry. Apply cream liberally and as often as necessary with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Babo Botanicals Sensitive Baby Fragrance Free Diaper Cream

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Babo Botanicals Sensitive Baby Fragrance Free Diaper Cream

Artwork Label_8566.jpgArtwork Label_8566.jpg

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69580-04769580-047-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
LECITHIN, SUNFLOWER834K0WOS5GIACT
ROSEMARYIJ67X351P9IACT
FILIPENDULA ULMARIA FLOWER06L18L32G6IACT
ZINC OXIDESOI2LOH54ZACTIB
SUNFLOWER OIL3W1JG795YIIACT
CORN OIL8470G57WFMIACT
NASTURTIUM OFFICINALE FLOWERING TOPW1N2U8I64GIACT
COCOA BUTTER512OYT1CRRIACT
SHEA BUTTERK49155WL9YIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CHAMOMILEFGL3685T2XIACT
COCONUT OILQ9L0O73W7LIACT
CANDELILLA WAXWL0328HX19IACT

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b9e92425-0984-2fa5-e053-2a95a90ad60eb9e92425-0983-2fa5-e053-2a95a90ad60e2021-01-27WarningsExact identifier
spl id: b9e92425-0984-2fa5-e053-2a95a90ad60e
spl set id: b9e92425-0983-2fa5-e053-2a95a90ad60e

Reported adverse events (FAERS/openFDA)#

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