CALMING DIAPER RASH OINTMENT

Manufacturer: ORGANIC & SUSTAINABLE BEAUTY
Effective date: 2020-11-06
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:33:08

Label at a glance#

ProductCALMING DIAPER RASH

Active ingredientZINC OXIDE

Label structure9 sections

Indications and uses

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

Dosage and administration

Apply an even layer for everyday protection and when a rash is present

Storage and handling

Protect the product in this container from excessive heat and direct sunlight Report serious adverse reactions to: 5933 Bowcroft St. Los Angeles, CA 90016

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 12%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Helps treat and prevent diaper rash

Protects chafed skin due to diaper rash
Helps seal out wetness

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product: keep out of eyes. Rinse with water to remove

OTC - STOP USE SECTION

Stop use and ask a doctor if: condition worsens. If 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

Apply an even layer for everyday protection and when a rash is present

Other information

STORAGE AND HANDLING SECTION

Protect the product in this container from excessive heat and direct sunlight

Report serious adverse reactions to: 5933 Bowcroft St. Los Angeles, CA 90016

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glyceryl starch, caprylic/capric triglyceride, lanolin, glyceryl stearate, cetearyl alcohol, glyceryl caprylate, cocos nucifera (coconut) oil, euphorbia cerifera (candelilla) wax, stearyl glycyrrhetinate (licorice), lavandula angustifolia (lavender) oil, melaleuca alternifolia (tea tree) leaf oil.

PRINCIPAL DISPLAY PANEL - 82 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CALIF♥RNIA BABY^®

TRUSTED
SINCE 1995

therapeutic relief™

CALMING
DIAPER RASH
OINTMENT
SKIN PROTECTANT

PRESERVATIVE FREE

USDA Certiﬁed Biobased
Product 100%

TREATS, PREVENTS & PROTECTS
FRENCH LAVENDER

BABIES + KIDS + ADULTS

ALLERGY
TESTED

NET WT 82 g/2.9 oz.

USDA
CERTIFIED
BIOBASED
PRODUCT
PRODUCT 100%

PRINCIPAL DISPLAY PANEL - 82 g Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
417994	zinc oxide 12 % Topical Cream	PSN	1
417994	zinc oxide 120 MG/ML Topical Cream	SCD	1
417994	zinc oxide 12 % Topical Cream	SY	1
417994	ZNO 120 MG/ML Topical Cream	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52915-069-05	2025-01-30	C162847	48780-1	2cef2736-86b1-d83d-e063-dadaa90ab31f	CALMING DIAPER RASH OINTMENT
52915-069-29	2025-01-30	C162847	48780-1	2cef2736-86b1-d83d-e063-dadaa90ab31f	CALMING DIAPER RASH OINTMENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52915-069-05	CALMING DIAPER RASH	14 g in 1 TUBE	CREAM	14		1
52915-069-29	CALMING DIAPER RASH	82 g in 1 TUBE	CREAM	82		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52915-069	CALMING DIAPER RASH (ZINC OXIDE) CREAM [ORGANIC & SUSTAINABLE BEAUTY]	1	Legacy NDC, 2 package rows	20201107_002af62f-0e47-4976-82da-b61e89989983.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

CALMING DIAPER RASH
ZINC OXIDE
DIMETHYLIMIDAZOLIDINONE RICE STARCH
MEDIUM-CHAIN TRIGLYCERIDES
lanolin
glyceryl stearate SE
CETOSTEARYL ALCOHOL
GLYCERYL MONOCAPRYLATE
COCONUT OIL
CANDELILLA WAX
stearyl glycyrrhetinate
LAVENDER OIL
TEA TREE OIL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52915-069	52915-069-29, 52915-069-05

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
ZINC OXIDE	SOI2LOH54Z	ACTIB
DIMETHYLIMIDAZOLIDINONE RICE STARCH	43YT4X3R70	IACT
MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	IACT
lanolin	7EV65EAW6H	IACT
glyceryl stearate SE	FCZ5MH785I	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
GLYCERYL MONOCAPRYLATE	TM2TZD4G4A	IACT
COCONUT OIL	Q9L0O73W7L	IACT
CANDELILLA WAX	WL0328HX19	IACT
stearyl glycyrrhetinate	3YYE6VJS0P	IACT
LAVENDER OIL	ZBP1YXW0H8	IACT
TEA TREE OIL	VIF565UC2G	IACT

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
6afed5fe-19a2-4e43-ab89-57eed6097e5a			002af62f-0e47-4976-82da-b61e89989983	2020-11-06	Warnings	Exact identifier spl id: 6afed5fe-19a2-4e43-ab89-57eed6097e5a spl set id: 002af62f-0e47-4976-82da-b61e89989983

Reported adverse events (FAERS/openFDA)#

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