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 167 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TuroSkin Daily Moisturizing Sunscreen broadspectrum spf15	AVOBENZONE,HOMOSALATE,OCTISALATE	Renuskin LLC	e36efd74-11c2-4850-9529-1c88b7364a33	2025-11-12	Warnings	Exact identifier application number: M020
TuroSkin Sport Sunscreen Broad Spectrum SPF 30 WR SR 80min	AVOBENZONE,HOMOSALATE,OCTISALATE	Renuskin LLC	22a40d93-ca67-4b7d-a95c-22f52cd6d297	2025-11-12	Warnings	Exact identifier application number: M020
ZEUS	ZINC OXIDE	NEWPORT APOTHECARY, INC	5354c383-08f0-4b89-b36a-96a35f47be3c	2025-11-12	Warnings	Exact identifier application number: M020
Practical Alchemy Hydrating SPF 30	ZINC OXIDE	Over Here, LLC	2f07df5b-dbd4-494c-a7cf-55843fb4d7c2	2025-11-12	Warnings	Exact identifier application number: M020
Dr Lift SPF 50 Mineral Sunscreen Stick	ZINC OXIDE	Spa de Soleil	436fdf4f-11db-7c5b-e063-6294a90a8731	2025-11-12	Warnings	Exact identifier application number: M020
CeraVe Developed with Dermatologists Skin Renewing Brightening with Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	L'Oreal USA Products Inc	3676aa91-c90d-4a7a-b02e-d5b35304a04d	2025-11-12	Warnings	Exact identifier application number: M020
HYDRATING GLOW MIST SPF 50	AVOBENZONE, OCTISALATE, OCTOCRYLENE	NAKED SUNDAYS PTY LTD	df3bd18d-63b4-460f-bf1c-115ad35edd96	2025-11-11	Warnings	Exact identifier application number: M020
Zinka Clear Zinc Oxide Sunscreen	OCTINOXATE, ZINC OXIDE, OCTISALATE, OXYBENZONE	Zinka, Inc.	7b097f5e-8127-49e6-8a77-4ee1fded5ff1	2025-11-11	Warnings	Exact identifier application number: M020
Total Sun Protection	OCTINOXATE, OCTISALATE, OXYBENZONE, ZINC OXIDE	Cosmed Dermaceuticals, Inc.	dbb16ef1-ab8c-4e71-a2a2-a507d104ff0f	2025-11-11	Warnings	Exact identifier application number: M020
Sunsorb Reef Safe SPF15	HOMOSALATE, OCTOCRYLENE, AVOBENZONE	QS Key West Aloe, LLC	1a1c17c4-4912-4573-9f59-cbd14a014cb4	2025-11-11	Warnings	Exact identifier application number: M020
Sunsorb Reef Safe SPF30	HOMOSALATE, OCTOCRYLENE, AVOBENZONE	QS Key West Aloe, LLC	14f65b3d-90bf-4689-aa6e-879e06153db9	2025-11-11	Warnings	Exact identifier application number: M020
Sunsorb Reef Safe SPF50	HOMOSALATE, ZINC OXIDE, OCTOCRYLENE	QS Key West Aloe, LLC	b4fc7a51-a163-4057-8790-f2111668ec67	2025-11-11	Warnings	Exact identifier application number: M020
Dr. Idriss Major Fade Disco Block Whipped Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	PILLOWTALKDERM LLC	30e10a62-8430-649b-e063-6394a90a97eb	2025-11-11	Warnings	Exact identifier application number: M020
Essential Defense Mineral Shield Broad Spectrum SPF 32 Sunscreen TINTED	TITANIUM DIOXIDE AND ZINC OXIDE	Allergan, Inc.	279a5214-79b2-44e9-b003-378d0b992395	2025-11-11	Warnings	Exact identifier application number: M020
Tinted Moisturizer SPF 46 Universal Tint	ZINC OXIDE, OCTINOXATE	Drmtlgy, LLC	5304b568-f891-4094-9182-363ae7bcfbe4	2025-11-11	Warnings	Exact identifier application number: M020
C Lip Serum Mineral Broad Spectrum SPF 30	SUNSCREEN	Simply Active Cosmetics	323661a6-3602-1ce2-e063-6394a90a8e91	2025-11-10	Warnings	Exact identifier application number: M020
buttah Tinted Mineral Sunscreen SPF-30	TITANIUM DIOXIDE, ZINC OXIDE	Buttah Enterprises, LLC.	43458152-0775-dd9c-e063-6394a90a6140	2025-11-10	Warnings	Exact identifier application number: M020
Aspen Glow 100% Mineral Broad Spectrum SPF 30 Powder Sunscreen 0.16 oz / 4.6 g	ZINC OXIDE	Aspen Glow Cosmetics, LLC	142eda44-76e1-7960-e063-6394a90a9ad6	2025-11-10	Warnings	Exact identifier application number: M020
TriLipiderm Broad Spectrum SPF 30	BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL METHOXYCINNAMATE, HOMOSALATE, OCTOCRYLENE	TriLipid Research Institute, LLC	617fc696-c2a1-4855-bafb-0454e6497101	2025-11-10	Warnings	Exact identifier application number: M020
TriLipiderm Protective Day	HOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE,BUTYL METHOXYDIBENZOYLMETHANE, OCTOCRYLENE	TriLipid Research Institute, LLC	66726c2b-27e9-5dd1-e053-2991aa0a1ba7	2025-11-10	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