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 203 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Face Reality Brilliant Defense Sunscreen SPF 50	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	Face Reality,LLC	618f58b7-2f29-4dff-8c3a-4fdbe1eb8ce4	2025-07-29	Warnings	Exact identifier application number: M020
Face Reality Power Mineral Sunscreen SPF 50	ZINC OXIDE	Face Reality,LLC	8c502e11-6e97-46d6-8775-1bbafaeb18f8	2025-07-29	Warnings	Exact identifier application number: M020
SPF30 unseen sunscreen stick 01	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	3afa3bdb-e924-55c1-e063-6394a90af352	2025-07-28	Warnings	Exact identifier application number: M020
Neutrogena Mineral Invisible Daily Defense Face Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Kenvue Brands LLC	003123d2-9675-fdd2-e063-6294a90a0130	2025-07-28	Warnings	Exact identifier application number: M020
Neutrogena Mineral Ultra Sheer Face SPF 70	TITANIUM DIOXIDE, ZINC OXIDE	Kenvue Brands LLC	20e0badf-fe25-1d27-e063-6294a90a7cfe	2025-07-28	Warnings	Exact identifier application number: M020
Basin Santas Cookies SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3b016dcf-fb74-916f-e063-6294a90a683d	2025-07-28	Warnings	Exact identifier application number: M020
Basin Vanilla SPF 30 Broad Spectrum Sunscreen Lip Balm SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Retail Concepts of Minnesota, Inc.	3b01c6a4-2230-c83e-e063-6294a90aa66d	2025-07-28	Warnings	Exact identifier application number: M020
Basin Peppermint Swirl SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3b022c84-00a5-ece9-e063-6294a90a09bd	2025-07-28	Warnings	Exact identifier application number: M020
Basin Winter Berry Blast SPF15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3b02c3f2-a43a-0d29-e063-6394a90a76b5	2025-07-28	Warnings	Exact identifier application number: M020
KARA VITA Moisturizing Sunscreen with DNArescue	OXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE	Kara Vita, Inc.	2130e9ac-5946-4b00-94d0-a78fd1ccfd13	2025-07-25	Warnings	Exact identifier application number: M020
78 x 36 SPF 30 Active	ZINC OXIDE	Dermazone LLC	96a8aacc-5c2f-410a-8fb4-8b3bc0f81e55	2025-07-25	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 01N Light	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	2ccf4e45-4cec-417d-9f4c-28f376025f1d	2025-07-25	Warnings	Exact identifier application number: M020
celazome Moisturizing SPF 30 Active	OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE	Dermazone LLC	5ec1510d-1465-4849-9e23-f16e11ff0e65	2025-07-25	Warnings	Exact identifier application number: M020
Skinuva Scar plus	ZINC OXIDE	MD Medical Designs, Inc.	5fcad8c3-a268-4966-b0a9-6cd2c7afd3b7	2025-07-25	Warnings	Exact identifier application number: M020
celazome Moisturizing SPF 29 Active with DNArescue	OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE	Dermazone LLC	99fb90ca-6527-459b-8af2-627ea9abe11b	2025-07-25	Warnings	Exact identifier application number: M020
The Men Pen TALLOW GUARD SPF 30 PREMIUM ZINC SUNSCREEN	ZINC OXIDE	Guangzhou Haishi Biological Technology Co., Ltd.	3aa93f52-ec01-01c2-e063-6294a90a9347	2025-07-24	Warnings	Exact identifier application number: M020
Mineral Suscreen SPF 30	ZINC OXIDE 19.0%	Vivant Pharmaceuticals, LLC	3aadb658-d12d-ae8d-e063-6394a90a6496	2025-07-24	Warnings	Exact identifier application number: M020
Sunscreen	TITANIUM DIOXIDE 6.8%	Baxter of California, LLC	146030bc-2bf4-25ea-e063-6294a90a4613	2025-07-24	Warnings	Exact identifier application number: M020
Leg and Body Makeup Broad Spectrum SPF 25	OCTISALATE 3.2% OCTOCRYLENE 6%	Baxter of California, LLC	14adc826-6e9d-382a-e063-6294a90a5d79	2025-07-24	Warnings	Exact identifier application number: M020
Tiege Hanley AM Morning Facial Moisturizer with SPF 20	AVOBENZENE, OCTINOXATE, OCTOCRYLENE	TIEGE HANLEY, Inc	22086cd8-2126-120e-e063-6394a90a561e	2025-07-24	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