FDA.reportPublic FDA data

Zinc Oxide

Manufacturer
Unconditional Love d/b/a Hello Bello | Unconditional Love
Effective date
2021-01-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:36:51

Label at a glance#

ProductZinc Oxide
Active ingredientZinc Oxide
Label structure8 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 and allow to dry Apply cream liberally as often as necessary, with each diaper change, and especially at bedtime or anytime when exposure to wet diapers may be prolonged

Label contents#

Full prescribing information#

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

Other information

OTHER SAFETY INFORMATION

OTC - DO NOT USE SECTION

Do not use if quality seal is broken

  • Do not store above 104°F/40°C

Warnings

WARNINGS SECTION

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 or 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 and allow to dry
  • Apply cream liberally as often as necessary, with each diaper change, and especially at bedtime or anytime when exposure to wet diapers may be prolonged

INACTIVE INGREDIENT SECTION

Helianthus Annuus (Sunflower) Seed Oil, Ricinus Communis (Castor) Seed Oil*, Hydrogenated Palm Oil**, Theobroma Cacao (Cocoa) Seed Butter**, Cetyl Palmitate**, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Calophyllum Inophyllum Seed Oil, Tocopherol, Zea Mays (Corn) Starch*

*Organic **RSPO Certified

Principal Display Panel – 118 mL Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Skin Protectant

hello
bello™

Made with sunflower seed,
coconut, and tamanu oils

Soothing Relief
Zinc Oxide Treatment

Diaper Rash
Cream

NET WT 4.0 fl. oz. (118ml) e

  • Hypoallergenic
  • Non-Nano Zinc Oxide
  • Pediatrician TestedPrincipal Display Panel – 118 mL Carton LabelPrincipal Display Panel – 118 mL Carton Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73418-010-012023-07-28C16284748780-1e4f33bdf-a5a4-d8a0-e053-dadaa90a6e4eDRUG FACTS
73418-010-022023-07-28C16284748780-1e4f33bdf-a5a4-d8a0-e053-dadaa90a6e4eDRUG FACTS
73418-010-012022-09-09C16284748780-1e4f33bdf-a5a4-d8a0-e053-dadaa90a6e4eDRUG FACTS
73418-010-022022-09-09C16284748780-1e4f33bdf-a5a4-d8a0-e053-dadaa90a6e4eDRUG FACTS
73418-010-012022-07-29C16284748780-1e4f33bdf-a5a4-d8a0-e053-dadaa90a6e4eDRUG FACTS
73418-010-022022-07-29C16284748780-1e4f33bdf-a5a4-d8a0-e053-dadaa90a6e4eDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73418-010-01Zinc Oxide118 mL in 1 TUBECREAM1181
73418-010-01Zinc Oxide1 in 1 BOXCREAM11
73418-010-02Zinc Oxide1 in 1 BOXCREAM11
73418-010-02Zinc Oxide236 mL in 1 TUBECREAM2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73418-010ZINC OXIDE CREAM [UNCONDITIONAL LOVE D/B/A HELLO BELLO]1Legacy NDC, 4 package rows20210113_cdd4166e-058a-4819-bc79-b877e4e4f2f7.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73418-01073418-010-01, 73418-010-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
Sunflower Oil3W1JG795YIIACT
Castor OilD5340Y2I9GIACT
Hydrogenated Palm Oil257THB963HIACT
Cocoa butter512OYT1CRRIACT
Cetyl Palmitate5ZA2S6B08XIACT
Shea ButterK49155WL9YIACT
Coconut OilQ9L0O73W7LIACT
Tamanu oilJT3LVK84A1IACT
.Alpha.-Tocopherol Acetate9E8X80D2L0IACT
Starch, CornO8232NY3SJIACT

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
0b7284b6-3699-4111-ad93-a4f8ec1a709fcdd4166e-058a-4819-bc79-b877e4e4f2f72021-01-08WarningsExact identifier
spl id: 0b7284b6-3699-4111-ad93-a4f8ec1a709f
spl set id: cdd4166e-058a-4819-bc79-b877e4e4f2f7

Reported adverse events (FAERS/openFDA)#

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