FDA.reportPublic FDA data

Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash Cream Spray

Manufacturer
Babo Botanicals, Inc.
Effective date
2023-10-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:57:31

Label at a glance#

ProductBabo Botanicals Sensitive Baby Fragrance Free Diaper Rash
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

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

Dosage and administration

Shake well before use Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry Spray 4-6 inches away from skin. Spray product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged No need to rub in.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 14.9%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Helps treat and prevent diaper rash
  • Protects minor skin irritation associated with diaper rash
  • 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 occurs 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Shake well before use
  • Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry
  • Spray 4-6 inches away from skin.
  • Spray product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
  • No need to rub in.

Other information

OTHER SAFETY INFORMATION

  • Protect this product from excessive heat and direct sun. May stain some fabrics and surfaces.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Olea Europaea (Olive) Fruit Oil, Propanediol, Ricinus Communis (Castor) Seed Oil, Bentonite, Glyceryl Rosinate, Cetearyl Alcohol, Butyrospermum Parkii (Shea) Butter*, Aloe Barbadensis (Aloe Vera) Leaf Juice*, Helianthus Annuus (Sunflower) Seed Oil*, Chamomilla Recutita (Matricaria) Flower Extract*, Calendula Officinalis Flower Extract*, Nasturtium Officinale (Watercress) Flower/Leaf Extract*, Spiraea Ulmaria (Meadowsweet) Flower Extract*, Olea Europaea (Olive) Oil Unsaponifiables, Caprylyl Glycol, Microcrystalline Cellulose, Coco-Glucoside, Glycerin, Caprylhydroxamic Acid, Cellulose Gum, Glyceryl Oleate.

*Certified Organic Ingredients

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-422-2987 Mon-Fri 9:00AM - 5:00PM EST

Company Information

SPL UNCLASSIFIED SECTION

Dist by Babo Botanicals, Inc.

60 East 56th Street New York, NY 10022

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79265-8576-1Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash89 mL in 1 BOTTLE, SPRAYSPRAY894

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79265-8576BABO BOTANICALS SENSITIVE BABY FRAGRANCE FREE DIAPER RASH (ZINC OXIDE) SPRAY [BABO BOTANICALS, INC.]4Current NDC, Legacy NDC, 1 package rows20231024_d66e369e-9b19-b084-e053-2995a90aa259.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79265-857679265-8576-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
ZINC OXIDESOI2LOH54ZACTIB
ALOE VERA LEAFZY81Z83H0XIACT
OLIVE OIL6UYK2W1W1EIACT
CASTOR OILD5340Y2I9GIACT
GLYCERINPDC6A3C0OXIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
PROPANEDIOL5965N8W85TIACT
GLYCERYL ROSINATESD112V492JIACT
BENTONITEA3N5ZCN45CIACT
NASTURTIUM OFFICINALE FLOWERING TOPW1N2U8I64GIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CHAMOMILEFGL3685T2XIACT
SHEA BUTTERK49155WL9YIACT
SUNFLOWER OIL3W1JG795YIIACT
FILIPENDULA ULMARIA FLOWER06L18L32G6IACT
CAPRYLYL GLYCOL00YIU5438UIACT
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLESXO45V955LTIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
WATER059QF0KO0RIACT
GLYCERYL OLEATE4PC054V79PIACT
COCO GLUCOSIDEICS790225BIACT

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
Babo Botanicals Sensitive Baby Fragrance Free Diaper RashZINC OXIDEBabo Botanicals, Inc.d66e369e-9b19-b084-e053-2995a90aa2592023-10-23WarningsExact identifier
ndc (package): 79265-8576-1
ndc (product): 79265-8576
ndc11 (package): 79265857601
spl id: 08651e5c-9236-0d03-e063-6294a90a21fc
spl set id: d66e369e-9b19-b084-e053-2995a90aa259

Reported adverse events (FAERS/openFDA)#

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