Cream

Product NDC: 61354-084
11-digit product format: 613540084
Labeler code: 61354
Product ID: 61354-084_e7763ac1-d05c-7f8f-e053-2995a90a6c15
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide, Titanium Dioxide
Dosage form: CREAM
Route: TOPICAL
Labeler: Oxygen Development LLC
Application: M020
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2022-08-30
Marketing end: 0000-00-00
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 5 mg/100mg; mg/100mg
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	61354-084		I	Inactivated by FDA		2026-10-21
excluded package	package	61354-084	61354-084-01	I	Inactivated by FDA		2026-10-21

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61354-084-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61354-084-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61354-084-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61354-084-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61354-084-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61354-084-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61354-084-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61354-084-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61354-084-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61354-084-01	2025-01-30	C162847	48780-1	2cef2736-62bf-d83d-e063-dadaa90ab31f	TARTE high-performance naturals BB tinted treatment primer Broad Spectrum SPF 30 Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61354-084-01	Cream	100 mg in 1 TUBE	CREAM	100		1
61354-084-01	Cream	1 in 1 CARTON	CREAM	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61354-084	CREAM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [OXYGEN DEVELOPMENT LLC]	1	Legacy NDC, 2 package rows	20220831_e7760899-8b4a-9a2a-e053-2995a90a2fd5.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 180 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Ivory	ZINC OXIDE	Cosmetic Enterprises Ltd	2748c351-0a7d-6913-e063-6394a90a6ef2	2025-10-13	Warnings	Exact identifier application number: M020
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Nude	ZINC OXIDE	Cosmetic Enterprises Ltd	265bd73f-2509-90c6-e063-6294a90a2e19	2025-10-13	Warnings	Exact identifier application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	dad4b244-2d34-40cb-88dc-991358df83b0	2025-10-10	Warnings	Exact identifier application number: M020
Neutrogena Beach Defense Kids Sunscreen SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Kenvue Brands LLC	eafc00ce-12e7-921f-e053-2995a90a241a	2025-10-10	Warnings	Exact identifier application number: M020
Kinesys	OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Wilc Healthcare Inc	50adf1db-118f-4843-b356-e23993160673	2025-10-10	Warnings	Exact identifier application number: M020
Kinesys Broad Spectrum SPF 30 Alcohol-Free Performance Sunscreen - Fragrance Free	OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Wilc Healthcare Inc	e0949325-7de1-4da4-82b6-8004916412a0	2025-10-10	Warnings	Exact identifier application number: M020
Meijer SPF 50 Sunscreen Mango	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Meijer	40d0294b-e937-336d-e063-6294a90a5c3c	2025-10-10	Warnings	Exact identifier application number: M020
Kinesys Broad Spectrum SPF 30 Kids Alcohol-Free Sunscreen	OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Wilc Healthcare Inc	9adea1a4-efa6-4fe1-85e8-ed69fa098a87	2025-10-10	Warnings	Exact identifier application number: M020
Kinesys Broad Spectrum SPF 30 Alcohol-Free Sunscreen - Mango Scent	OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Wilc Healthcare Inc	60e7ed8e-f421-4e08-97a8-af647200e4ae	2025-10-10	Warnings	Exact identifier application number: M020
KINeSYS Pro Sport Lip Balm with Shea Butter Broad Spectrum 30	ZINC OXIDE	Wilc Healthcare Inc	e5820376-897f-4c77-aadc-7991137870b7	2025-10-10	Warnings	Exact identifier application number: M020
KINeSYS Pro Sport Clear Mineral Sunscreen Stick Broad Spectrum SPF45	ZINC OXIDE	Wilc Healthcare Inc	247a323f-9a08-4717-8553-ebc9c519817b	2025-10-10	Warnings	Exact identifier application number: M020
Vertra S Dorian Kona Gold Signature Face Stick SPF 38	TITANIUM DIOXIDE	Eai-jr 286, Inc	b6c316c3-661b-6428-e053-2a95a90a1a6b	2025-10-10	Warnings	Exact identifier application number: M020
Meijer SPF 50 Sunscreen Coconut	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Meijer	40d15366-85b8-f5e8-e063-6294a90a5fd8	2025-10-10	Warnings	Exact identifier application number: M020
Premium Moisturizing Sunscreen Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Wasatch Product Development, LLC	f4369f2f-fdc3-e48e-e053-2995a90a07f7	2025-10-10	Warnings	Exact identifier application number: M020
Sun Bum Face 50 Premium Sunscreen SPF 50	AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE	Wasatch Product Development, LLC	f4ac746a-a50a-8041-e053-2a95a90a8ea6	2025-10-10	Warnings	Exact identifier application number: M020
Wonderscreen Broad Spectrum SPF 30	ZINC OXIDE	Wasatch Product Development, LLC.	e895d942-e50e-1ad6-e053-2995a90a0e02	2025-10-10	Warnings	Exact identifier application number: M020
Illuminating SPF 50 plus drops Broad Spectrum Sunscreen	ZINC OXIDE	Cosmetic Enterprise Ltd	13f40485-b98e-e804-e063-6394a90af2af	2025-10-10	Warnings	Exact identifier application number: M020
Impeccable Skin Moisturizing Face Sunscreen Broad Spectrum SPF 30	ZINC OXIDE	Cosmetic Enterprises LTD	a84d246b-1153-85ff-e053-2995a90a270a	2025-10-10	Warnings	Exact identifier application number: M020
MediChoice Moisturizing Lip Balm SPF15	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	O&M HALYARD, INC.	00327815-28f0-4198-bca7-c8ae768ff416	2025-10-09	Warnings	Exact identifier application number: M020
Daybird 4-in-1 Skin Tint Serum	ZINC OXIDE	Resette, Inc.	19c1a934-b0f5-1068-e063-6294a90a3b1f	2025-10-09	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61354-084-01	61354008401	1 TUBE in 1 CARTON (61354-084-01) > 100 mg in 1 TUBE	1 tube	2022-08-30	0000-00-00	No	No	Current