FDA.reportPublic FDA data

Baby Diaper Rash Cream

Manufacturer
doTERRA International, LLC
Effective date
2025-01-28
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:53:55

Label at a glance#

ProductBaby Diaper Rash Cream
Active ingredientZINC OXIDE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 25%

Zinc OxideZinc Oxide

OTC - PURPOSE SECTION

Skin protectant Drug FactsDrug Facts

INDICATIONS & USAGE SECTION

Uses

• Helps treat and prevent diaper rash
• Protects chafed skin due to diaper rash and
helps seal out wetness

WARNINGS SECTION

For external use only.

Drug FactsDrug Facts

OTC - WHEN USING SECTION

When using this product do not get into eyes

OTC - STOP USE SECTION

DF Diaper CreamDF Diaper CreamStop 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 immediately.

OTHER SAFETY INFORMATION

Other information

• Store between 20º to 25ºC (68º to 77ºF)
• Do not use if quality seal is broken

INACTIVE INGREDIENT SECTION

Inactive ingredients: Caprylic/Capric Triglyceride, Simmondsia chinensis
(Jojoba) Seed Oil, Beeswax (Cera Alba),
Butyrospermum parkii (Shea) Butter, Carthamus
tinctorius (Safflower) Oleosomes, Water (Aqua),
Caprylyl Glycol, Lavandula angustifolia (Lavender)
Oil, Daucus carota sativa (Carrot) Seed Oil,
Melaleuca alternifolia (Tea Tree) Leaf Oil

DFPDFP

OTC - QUESTIONS SECTION

Questions? Call 1-800-411-8151

DOSAGE & ADMINISTRATION SECTION

Active ingredient Purpose

Zinc Oxide 25%...........................Skin Protectant

Directions

• Change wet or soiled diapers promptly
• Cleanse the diaper area and allow 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

Principal Display Panel and Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

doTERRA® baby

Diaper Rash Cream

Helps Treat, Soothe, and Prevent Diaper Rash

Net wt. 2.1 oz/60 g

PDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1125471zinc oxide 25 % Topical CreamPSN6
1125471zinc oxide 250 MG/ML Topical CreamSCD6
1125471zinc oxide 25 % Topical CreamSY6
1125471ZNO 250 MG/ML Topical CreamSY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71630-549-602022-01-31C16284748780-19d75b9d0-a978-f424-e053-dadaa90a57ceBaby Diaper Rash Cream
71630-549-602022-01-28C16284748780-19d75b9d0-a978-f424-e053-dadaa90a57ceBaby Diaper Rash Cream
71630-549-602020-02-03C16284748780-19d75b9d0-a978-f424-e053-dadaa90a57ceBaby Diaper Rash Cream
71630-549-602020-01-31C16284748780-19d75b9d0-a978-f424-e053-dadaa90a57ceBaby Diaper Rash Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71630-549-60Baby Diaper Rash Cream60 g in 1 TUBECREAM606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71630-549BABY DIAPER RASH CREAM (ZINC OXIDE) CREAM [DOTERRA INTERNATIONAL, LLC]6Current NDC, Legacy NDC, 1 package rows20250130_641465a1-0daf-1bb9-e053-2a91aa0ab25d.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71630-54971630-549-60

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
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
JOJOBA OIL724GKU717MIACT
CARROT SEED OIL595AO13F11IACT
YELLOW WAX2ZA36H0S2VIACT
CAPRYLYL GLYCOL00YIU5438UIACT
LAVENDER OILZBP1YXW0H8IACT
TEA TREE OILVIF565UC2GIACT
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES9S60Q72309IACT
ZINC OXIDESOI2LOH54ZACTIB
SHEA BUTTERK49155WL9YIACT

Source Document#

Source XML · Source PDF

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
Baby Diaper Rash CreamZINC OXIDEdoTERRA International, LLC641465a1-0daf-1bb9-e053-2a91aa0ab25d2025-01-28WarningsExact identifier
ndc (package): 71630-549-60
ndc (product): 71630-549
ndc11 (package): 71630054960
spl id: 2ccb71b9-14a3-ffee-e063-6294a90a8285
spl set id: 641465a1-0daf-1bb9-e053-2a91aa0ab25d

Reported adverse events (FAERS/openFDA)#

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