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		2026-10-23
excluded package	package	61354-084	61354-084-01	I	Inactivated by FDA		2026-10-23

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 213 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Age Defense for Eyes 5 in 1	ZINC OXIDE AND TITANIUM DIOXIDE	Topiderm, Inc.	48d5343a-1068-4c64-a275-c180026d6947	2025-06-03	Warnings	Exact identifier application number: M020
Ola Botanicals Sunscreen SPF 30	ZINC OXIDE	Natural Health Partners, LLC	c7a7df0b-da8f-407d-a1ee-28f75070b23c	2025-06-02	Warnings	Exact identifier application number: M020
MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50	ZINC OXIDE	Expanscience Laboratories d/b/a Mustela	95ea5442-a7ca-0c7d-e053-2a95a90ad247	2025-06-02	Warnings	Exact identifier application number: M020
Bluevado Sunfix	ZINC OXIDE, TITANIUM DIOXIDE	Magic Blue, LLC	31f1e961-3719-f70a-e063-6394a90a481e	2025-05-31	Warnings	Exact identifier application number: M020
Sunny Sailor First Mate Face Stick SPF 30	ZINC OXIDE	SUNNY SAILOR LLC	8ef7e0c8-e76b-4e84-ac9d-169f85e5e36e	2025-05-28	Warnings	Exact identifier application number: M020
Dr Mercola Broad Spectrum SPF15	ZINC OXIDE	Natural Health Partners, LLC	47f6b19e-ede8-0daf-e054-00144ff88e88	2025-05-28	Warnings	Exact identifier application number: M020
Dr. Mercola Broad Spectrum	ZINC OXIDE	Natural Health Partners, LLC	47f6ec0a-1144-55dd-e054-00144ff8d46c	2025-05-28	Warnings	Exact identifier application number: M020
Dr. Mercola Broad Spectrum	TITANIUM DIOXIDE, ZINC OXIDE	Natural Health Partners, LLC	47f6ab9e-fa73-496a-e054-00144ff8d46c	2025-05-28	Warnings	Exact identifier application number: M020
Celavive Protective Day SPF 30	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE	USANA Health Sciences, Inc.	cf00763f-6b3e-4d50-b639-9a6d6f595961	2025-05-28	Warnings	Exact identifier application number: M020
TALLOW SUNSCREEN	NON-NANO ZINC OXIDE	FOUNDATION COMMERCE INC	363e38bf-b4b4-dcc4-e063-6294a90a5d2f	2025-05-28	Warnings	Exact identifier application number: M020
CoreTex SunX 50 Facestick	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CoreTex Products Inc	364989ea-c93b-d404-e063-6294a90abd09	2025-05-28	Warnings	Exact identifier application number: M020
Solvaderm Universal Tinted Moisturizer Sunscreen SPF 30	OCTINOXATE, ZINC OXIDE	SOLVADERM LLC	86dbd8c3-e95a-49a8-afe6-ff9d985e28ba	2025-05-27	Warnings	Exact identifier application number: M020
NATUREWELL HYDRASUN LIP BALM SPF30 CITRUS SPRITZ	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LIP BALM	Port Jervis Laboratories, Inc.	350b4cce-1627-5b8f-e063-6294a90aa6bf	2025-05-26	Warnings	Exact identifier application number: M020
Protect Daily Ritual Mineral Sunscreen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	Melinda Menezes, M.D., Inc.	35ce8307-387b-2b40-e063-6294a90a28bc	2025-05-23		Exact identifier application number: M020
OS-01 FACE SPF BD SPF 30 TINTED MEDIUM/DEEP	ZINC OXIDE	ONESKIN INC.	35d57d3f-376c-2307-e063-6294a90adf51	2025-05-23	Warnings	Exact identifier application number: M020
Oathology Inzincable Lip Balm SPF 35	ZINC OXIDE	SKINOATH LLC	289a5492-af57-42e5-82af-3f1e4b369d68	2025-05-22	Warnings	Exact identifier application number: M020
NAELI Tinted Mineral Moisturizer Sunscreen SPF 50, Light	ZINC OXIDE	ALLI LLC	3cb4459b-1776-414a-b5c4-0ffb9f1df766	2025-05-22	Warnings	Exact identifier application number: M020
NAELI Tinted Mineral Moisturizer Sunscreen SPF 50, Dark	ZINC OXIDE	ALLI LLC	81633684-f9ac-45cb-8a3e-f0c30b229a82	2025-05-22	Warnings	Exact identifier application number: M020
Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Melinda Menezes, M.D., Inc.	35bea4f3-c19e-3e2e-e063-6394a90aeb69	2025-05-22		Exact identifier application number: M020
LBEL FOREVER HYDRA LONGWEAR AND HYDRATING FOUNDATION 90H SPF 15 ALMENDRA 230N	OCTINOXATE, ZINC OXIDE	BEL STAR S.A.	35c106b6-9a80-01e3-e063-6294a90abc35	2025-05-22	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