Baby Bum Diaper Rash Cream

Manufacturer: Sun Bum LLC
Effective date: 2022-02-04
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:48:05

Label at a glance#

ProductBaby Bum Diaper Rash

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 area to dry apply cream liberally as often as necessary with each diaper change, especially at bedtime or any time exposure to wet diapers may be prolonged

Contacts and useful links#

PhoneLabel contact1-877-978-6286

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc oxide 16%

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 withing 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

change wet and soiled diapers promptly
cleanse the diaper area and allow area to dry
apply cream liberally as often as necessary with each diaper change, especially at bedtime or any time exposure to wet diapers may be prolonged

Other Information

SPL UNCLASSIFIED SECTION

store between 20° to 25°C (68° to 77°F)
do not use if quality seal is broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

ricinus communis (castor) seed oil, hydrogenated castor oil, cocos nucifera (coconut) oil, beeswax, butyrospermum parkii (shea) butter, simmondsia chinensis (jojoba) seed oil, theobroma cacao (cocoa) seed butter, persea gratissima (avocado) oil, aloe barbadensis leaf extract, gardenia taitensis flower extract, tocopherol, hydrogenated vegetable oil

Questions?

OTC - QUESTIONS SECTION

1-877-978-6286

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2556908	zinc oxide 16 % Topical Cream	PSN	2
2556908	zinc oxide 160 MG/ML Topical Cream	SCD	2
2556908	ZNO 160 MG/ML Topical Cream	SY	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
ZINC CATION Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69039-638-02	2025-01-30	C162847	48780-1	2cef2736-9e6f-d83d-e063-dadaa90ab31f	Baby Bum Diaper Rash Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69039-638-02	Baby Bum Diaper Rash	85 g in 1 TUBE	CREAM	85		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69039-638	BABY BUM DIAPER RASH (ZINC OXIDE) CREAM [SUN BUM LLC]	2	Legacy NDC, 1 package rows	20220205_c46d5dfe-259a-1699-e053-2a95a90aba06.zip

Products#

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

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

Baby Bum Diaper Rash
ZINC OXIDE
CASTOR OIL
HYDROGENATED CASTOR OIL
COCONUT OIL
YELLOW WAX
SHEA BUTTER
JOJOBA OIL
COCOA BUTTER
AVOCADO OIL
ALOE VERA LEAF
GARDENIA TAITENSIS FLOWER
TOCOPHEROL
ZINC CATION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69039-638	69039-638-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CASTOR OIL	D5340Y2I9G	IACT
HYDROGENATED CASTOR OIL	ZF94AP8MEY	IACT
COCONUT OIL	Q9L0O73W7L	IACT
YELLOW WAX	2ZA36H0S2V	IACT
SHEA BUTTER	K49155WL9Y	IACT
JOJOBA OIL	724GKU717M	IACT
COCOA BUTTER	512OYT1CRR	IACT
AVOCADO OIL	6VNO72PFC1	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
GARDENIA TAITENSIS FLOWER	T0OCU8201Y	IACT
TOCOPHEROL	R0ZB2556P8	IACT
ZINC OXIDE	SOI2LOH54Z	ACTIM

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
d72d2eea-7fea-a664-e053-2a95a90ab645			c46d5dfe-259a-1699-e053-2a95a90aba06	2022-02-04	Warnings	Exact identifier spl id: d72d2eea-7fea-a664-e053-2a95a90ab645 spl set id: c46d5dfe-259a-1699-e053-2a95a90aba06

Reported adverse events (FAERS/openFDA)#

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