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 164 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 33W	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	43d506dd-4103-de3c-e063-6294a90ac190	2025-11-17	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 35N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	43d5174f-6bd2-1294-e063-6294a90a407b	2025-11-17	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 41N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	43d5299f-6273-30ab-e063-6294a90a082e	2025-11-17	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 47N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	43d53bac-560d-6e4d-e063-6394a90a40c4	2025-11-17	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 13C	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	43d55c3d-4550-8131-e063-6394a90a0eed	2025-11-17	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 15C	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	43d56169-4843-8546-e063-6294a90a8a10	2025-11-17	Warnings	Exact identifier application number: M020
BRING GREEN TEA TREE CICA SUN CUSHION	ZINC OXIDE, TITANIUM DIOXIDE	CJ Olive Young Corporation	30850a56-6438-dbe1-e063-6294a90a6d9f	2025-11-17	Warnings	Exact identifier application number: M020
BRING GREEN TEA TREE CICA SUNCREAM	ZINC OXIDE	CJ Olive Young Corporation	30bdb3c6-2bfa-87c2-e063-6394a90a9a43	2025-11-17	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 29C	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	43c73747-82b6-c71c-e063-6294a90aea52	2025-11-17	Warnings	Exact identifier application number: M020
Arnies Mineral Sunscreen - Broad Spectrum SPF 50 with Zinc Oxide	ZINC OXIDE	Gimmie Botanicals LLC	43e24a9a-a25c-f011-e063-6394a90abbb2	2025-11-17	Warnings	Exact identifier application number: M020
Naked Sundays Glow Balm Mineral Peptide Stick Broad Spectrum SPF50 Pink Pop 8g	ZINC OXIDE	NAKED SUNDAYS PTY LTD	2f46049b-7e81-9c7e-e063-6394a90a8f49	2025-11-14	Warnings	Exact identifier application number: M020
Huey Daily Mineral	TITANIUM DIOXIDE, ZINC OXIDE	Huey	15bdf9c6-3bfa-4eef-e063-6294a90a195f	2025-11-14	Warnings	Exact identifier application number: M020
Pipette Diaper Rash	ZINC OXIDE	Pipette LLC	2a93998c-1855-9207-e063-6294a90ab0e9	2025-11-14	Warnings	Exact identifier application number: M020
Ware Sonny Universal	TITANIUM DIOXIDE, ZINC OXIDE	Ware Cosmetics	fe2b9d16-9215-e21e-e053-6394a90a5156	2025-11-14	Warnings	Exact identifier application number: M020
YAY NOVELTY ALL-IN-ONE	TITANIUM DIOXIDE, ZINC OXIDE	YAY Novelty	fb833158-d0d8-de7f-e053-6294a90adc5a	2025-11-14	Warnings	Exact identifier application number: M020
Thu Brule Free Spirit Correct and Protect	TITANIUM DIOXIDE, ZINC OXIDE	Laughing Buddha LLC	258a4f97-d811-0521-e063-6394a90aaf3b	2025-11-14	Warnings	Exact identifier application number: M020
Alpha-H Total Eclipse	TITANIUM DIOXIDE, ZINC OXIDE	Alpha-H	fc8a4efe-7d5e-5f44-e053-6394a90a80aa	2025-11-14	Warnings	Exact identifier application number: M020
Svens Everyday Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Svens, Inc	912170ae-124c-5eb9-e053-2995a90a0ba3	2025-11-14	Warnings	Exact identifier application number: M020
Wander Beauty Pack Up and Glow Priming	TITANIUM DIOXIDE, ZINC OXIDE	Wander Beauty	3d844efc-091c-9a9b-e063-6294a90aee7c	2025-11-14	Warnings	Exact identifier application number: M020
Baby Bare Republic Mineral Sunscreen	ZINC OXIDE	COOLA, LLC	b292d1a9-7ff8-0faf-e053-2995a90ae342	2025-11-14	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