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 230 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SOME BY MI V10 HYAL LIP SUN PROTECTOR ROSY	AVOBENZONE, HOMOSALATE, OCTISALATE	PERENNEBELL Co., Ltd	2dc25afb-a171-f1f2-e063-6294a90ae333	2025-02-09	Warnings	Exact identifier application number: M020
SOME BY MI V10 HYAL LIP SUN PROTECTOR BERRY	AVOBENZONE, HOMOSALATE, OCTISALATE	PERENNEBELL Co., Ltd	2dc285ad-08cd-14e6-e063-6294a90a24fc	2025-02-09	Warnings	Exact identifier application number: M020
PROBIOTIC RICE Sunscreen	PROBIOTIC RICE SUNSCREEN	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	2d9d6440-39b3-312a-e063-6394a90aa072	2025-02-08	Warnings	Exact identifier application number: M020
NIA 24 SPF 30	HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE	Niadyne Inc	e5c9d56f-48b4-4f0e-add6-f73268755b16	2025-02-07	Warnings	Exact identifier application number: M020
Pacific Mango Sunscreen SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	SAN DIEGO NATURAL SOAP COMPANY	d09e3096-0678-4433-a555-61f18a45873b	2025-02-06	Warnings	Exact identifier application number: M020
DR.JART CICAPAIR TIGER GRASS COLOR CORRECTING TREATMENT	ZINC OXIDE, TITANIUM DIOXIDE	Have & Be Co., Ltd.	01cfe6a6-c2e4-8fb8-e063-6294a90adc78	2025-02-06	Warnings	Exact identifier application number: M020
Dr.Jart Premium Beauty Balm Medium-Tan	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Have & Be Co., Ltd.	02a8bab8-ca5d-6b65-e063-6294a90abb07	2025-02-06	Warnings	Exact identifier application number: M020
Dr.Jart Premium Beauty Balm Fair-Light	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Have & Be Co., Ltd.	02a82029-bdb1-cbe0-e063-6294a90a08f3	2025-02-06	Warnings	Exact identifier application number: M020
Dr.Jart Premium Beauty Balm Light Medium-Medium	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Have & Be Co., Ltd.	02a87c6b-3c7d-5942-e063-6294a90aa452	2025-02-06	Warnings	Exact identifier application number: M020
DR.JART EVERY SUN DAY MINERAL SUN SCREEN	TITANIUM DIOXIDE, ZINC OXIDE	Have & Be Co., Ltd.	02a671ed-485d-d6b7-e063-6394a90ad4af	2025-02-06	Warnings	Exact identifier application number: M020
Dr.Jart Cicapair Tiger Grass Camo Drops	ZINC OXIDE, TITANIUM DIOXIDE	Have & Be Co., Ltd.	01cf0522-a3c1-aea8-e063-6294a90aabfe	2025-02-06	Warnings	Exact identifier application number: M020
DR.JART EVERY SUN DAY SUN FLUID	HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	Have & Be Co., Ltd.	02a72c6d-da42-14b2-e063-6394a90af5cb	2025-02-06	Warnings	Exact identifier application number: M020
EMMA LEWISHAM Sunceutical SPF 50 Mineral Glow Serum	ZINC OXIDE 20%	EMMA LEWISHAM US, INC.	2b097709-913f-d906-e063-6394a90a0446	2025-02-05	Warnings	Exact identifier application number: M020
EMMA LEWISHAM Sunceutical SPF 50 Mineral Face Cream	ZINC OXIDE 20%	EMMA LEWISHAM US, INC.	2c703df8-23af-d630-e063-6294a90a1a24	2025-02-05	Warnings	Exact identifier application number: M020
doTERRA Sun	ZINC OXIDE	doTERRA International, LLC	dd308fef-e312-4ced-e053-2995a90a76fd	2025-02-05	Warnings	Exact identifier application number: M020
OrgaPlus Ultra Pure Sun EX 15g	OCTINOXATE, OCTISALATE, OCTOCRYLENE	BLUEZONWIDE CO.,LTD	b686ef63-7eee-4a4d-a559-417d8b09cc4f	2025-02-05	Warnings	Exact identifier application number: M020
OrgaPlus Ultra Pure Sun EX 22g	OCTINOXATE, OCTISALATE, OCTOCRYLENE	BLUEZONWIDE CO.,LTD	d3c422f6-a83d-48fc-94fc-2749666426c8	2025-02-05	Warnings	Exact identifier application number: M020
EMMA LEWISHAM Sunceutical SPF 50 Mineral Body Cream	ZINC OXIDE 20%	EMMA LEWISHAM US, INC.	2d65b2d0-7013-d0ad-e063-6394a90ad4c2	2025-02-05	Warnings	Exact identifier application number: M020
Olay Sun Hydrating Facial Moisturizer with Sunscreen SPF 30 Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	2d6a6fed-a26e-e3a6-e063-6394a90ae2c7	2025-02-05	Warnings	Exact identifier application number: M020
Brush On Block Sheer Genius SPF 50 Mineral Moisture	ZINC OXIDE	SPF Ventures, LLC	2d4b8c92-b932-89a7-e063-6394a90a621d	2025-02-04	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