Baby Diaper Rash Cream

Product NDC: 71630-549
11-digit product format: 716300549
Labeler code: 71630
Product ID: 71630-549_2ccb71b9-14a3-ffee-e063-6294a90a8285
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: doTERRA International, LLC
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-05-09
Substance: ZINC OXIDE
Active strength: 25 g/100g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Baby Diaper Rash Cream
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	25 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1125471	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
641465a1-0daf-1bb9-e053-2a91aa0ab25d	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2022-01-31	Baby Diaper Rash Cream
2022-01-28	Baby Diaper Rash Cream
2020-02-03	Baby Diaper Rash Cream
2020-01-31	Baby Diaper Rash Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71630-549-60	Baby Diaper Rash Cream	60 g in 1 TUBE	CREAM	60		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71630-549	BABY DIAPER RASH CREAM (ZINC OXIDE) CREAM [DOTERRA INTERNATIONAL, LLC]	6	Current NDC, Legacy NDC, 1 package rows	20250130_641465a1-0daf-1bb9-e053-2a91aa0ab25d.zip

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 18 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
La Roche Posay Laboratoire Dermatologique Anthelios Broad Spectrum SPF 100 Body and Face Melt In Milk Sunscreen Water Resistant 80 Minutes	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	511f6de9-264a-4cf2-97c3-aa8adbc52a87	2026-06-23	Warnings	Exact identifier application number: M020
fmg Cashmere Lip Glaze Broad Spectrum SPF 30 Sunscreen	ZINC OXIDE	THE AVON COMPANY	54f1b153-c79b-bcf8-e063-6394a90ae426	2026-06-23	Warnings	Exact identifier application number: M020
CVS 70 Daily Clear Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS PHARMACY	54f25934-b4c4-4fc8-e063-6294a90a543a	2026-06-23	Warnings	Exact identifier application number: M020
Soleil Set sunscreen SPF 50	AVABENZONE 3% HOMOSALATE 10% OCTISALATE 5%	The Soleil Group	cc4e4b99-5f42-4a93-a3a0-ea19f57d2783	2026-06-23	Warnings	Exact identifier application number: M020
AVON ANEW SOLAIRE EVERYDAY FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	THE AVON COMPANY	54f6d7c1-59d1-0b36-e063-6394a90a17a3	2026-06-23	Warnings	Exact identifier application number: M020
RYDEEN UV CLEAR	SUNSCREEN	Guangzhou Oupeng Cosmetics Co., Ltd.	548000cd-1655-aeb3-e063-6294a90ad004	2026-06-22	Warnings	Exact identifier application number: M020
Good Instincts Proper Sunscreen SPF 50	ZINC OXIDE, TITANIUM DIOXIDE	Inhabit Brands, Inc	82d2af99-7c42-4ce5-94e0-b2ac60b8db1b	2026-06-22	Warnings	Exact identifier application number: M020
Mama and Hapa s - Bulk Sunscreen Extra Sensitive	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	54e18569-2e51-366a-e063-6394a90af8ec	2026-06-22	Warnings	Exact identifier application number: M020
ESPOIR BE VELVET COVER CUSHION	HOMOSALATE, TITANIUM DIOXIDE	ESPOIR Corporation	54ce2420-4ac0-eb51-e063-6294a90a2de9	2026-06-21	Warnings	Exact identifier application number: M020
BABIES KIDSSUN PROTECTION	MINERAL SUNSCREEN	PANERGYTEK USA INC	3a554118-b71d-a844-e063-6294a90a699f	2026-06-20	Warnings	Exact identifier application number: M020
By the Beach Suncare	SPF 30 SUNCARE COCO LOCO	By the Beach Suncare LLC	549be1ca-df21-a643-e063-6394a90ac026	2026-06-19	Warnings	Exact identifier application number: M020
By the Beach Suncare	SPF 30 FACE AND BODY DRY OIL COCO LOCO	By the Beach Suncare LLC	549bad35-3005-875b-e063-6394a90ad31e	2026-06-19	Warnings	Exact identifier application number: M020
By the Beach Suncare	SPF 30 FACE AND BODY DRY OIL MELON DAZE	By the Beach Suncare LLC	549bbd19-8e22-e420-e063-6294a90a6a98	2026-06-19	Warnings	Exact identifier application number: M020
By the Beach Suncare	SPF 30 FACE AND BODY DRY OIL CANDY CLOUDS	By the Beach Suncare LLC	549bd1b1-a6e2-b35c-e063-6394a90a8d0e	2026-06-19	Warnings	Exact identifier application number: M020
By the Beach Suncare	SPF 30 FACE AND BODY DRY OIL CITRUS CRUSH	By the Beach Suncare LLC	549bd1b1-a6ee-b35c-e063-6394a90a8d0e	2026-06-19	Warnings	Exact identifier application number: M020
FHF Elevated Shade 100% Mineral Sunscreen	SUNSCREEN	Summer Soles, LLC dba Farm House Freash Goods	5488fd8c-7ef2-22c2-e063-6394a90aff3c	2026-06-18	Warnings	Exact identifier application number: M020
Stream2Sea Sport Lip Balm SPF 50	ZINC OXIDE	Stream2Sea, LLC	5489fea5-bc0e-82cf-e063-6294a90aa097	2026-06-18	Warnings	Exact identifier application number: M020
Creamy Beige Perfecting Makeup Broad Spectrum SPF 25	OCTINOXATE, TITANIUM DIOXIDE	Merle Norman Cosmetics, Inc	548b7c90-ef97-38ab-e063-6394a90ac609	2026-06-18	Warnings	Exact identifier application number: M020
UV SOLUTIONS HYDRATING BROAD SPECTRUM SPF 50	AVOBENZONE,HOMOSALATE,OCTISALATE, AND OCTOCRYLENE	CLINIQUE LABORATORIES LLC	4a6f9be3-2a56-8b41-e063-6294a90a30f8	2026-06-18	Warnings	Exact identifier application number: M020
Mineral Sunscreen SPF 50	MINERAL SUNSCREEN	ALAINA HEALTHCARE PRIVATE LIMITED	7e036f9f-b26d-4f11-911c-c1fa854edb0f	2026-06-17	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1125471	zinc oxide 25 % Topical Cream	PSN	641465a1-0daf-1bb9-e053-2a91aa0ab25d	6
1125471	zinc oxide 250 MG/ML Topical Cream	SCD	641465a1-0daf-1bb9-e053-2a91aa0ab25d	6
1125471	zinc oxide 25 % Topical Cream	SY	641465a1-0daf-1bb9-e053-2a91aa0ab25d	6
1125471	ZNO 250 MG/ML Topical Cream	SY	641465a1-0daf-1bb9-e053-2a91aa0ab25d	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71630-549-60	71630054960	60 g in 1 TUBE (71630-549-60)	60 g	2018-05-09	0000-00-00	No	No	Current