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		2026-10-20
excluded package	package	61354-084	61354-084-01	I	Inactivated by FDA		2026-10-20

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 145 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Perfect Sunscreen SPF 50 Sheer Mineral	ZINC OXIDE	Bluemercury, Inc.	d8f483ff-b990-40c5-b5b8-00065051ae7e	2025-12-09	Warnings	Exact identifier application number: M020
Foto Facial Age Delay Non-Tinted	TITANIUM DIOXIDE ZINC OXIDE	ADVANCED AESTHETIC DERMATOLOGY	42674013-fa2b-42d7-e063-6294a90af999	2025-12-09	Warnings	Exact identifier application number: M020
Hydraboost Moisturizer SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Bluemercury	eca867e6-4deb-4be2-ae3f-6850fb6223b3	2025-12-09	Warnings	Exact identifier application number: M020
Foto Facial Age Delay Matte Tinted	TITANIUM DIOXIDE ZINC OXIDE	ADVANCED AESTHETIC DERMATOLOGY	42761919-8ae2-3c41-e063-6394a90abb8f	2025-12-09	Warnings	Exact identifier application number: M020
Dew Mineral	ZINC OXIDE	ADVANCED AESTHETIC DERMATOLOGY	42f17245-92a9-3915-e063-6394a90a6817	2025-12-09	Warnings	Exact identifier application number: M020
Mineral Sunscreen Non-Tinted	TITANIUM DIOXIDE, ZINC OXIDE	YUMA ACNE CLINIC, L.L.C.	3c69b707-07ff-1a82-e063-6394a90a9fcd	2025-12-09	Warnings	Exact identifier application number: M020
Mineral Sunscreen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	YUMA ACNE CLINIC, L.L.C.	3c69f93f-0385-365c-e063-6394a90a12fd	2025-12-09	Warnings	Exact identifier application number: M020
Replenishing Daily Protection Tinted	ZINC OXIDE	YUMA ACNE CLINIC, L.L.C.	3c6a5601-a7a2-5e20-e063-6394a90a6643	2025-12-09	Warnings	Exact identifier application number: M020
Bronzing Blendrops Broad Spectrum SPF 40	HOMOSALATE, OCTISALATE, ZINC OXIDE	Wasatch Product Development, LLC	124ca946-8412-4d6d-e063-6294a90a6338	2025-12-09	Warnings	Exact identifier application number: M020
Perfecting Blendrops Broad Spectrum SPF 40	HOMOSALATE, OCTISALATE, ZINC OXIDE	Wasatch Product Development, LLC	12512cac-652e-b138-e063-6394a90ad1f2	2025-12-09	Warnings	Exact identifier application number: M020
Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	ASHLEY SAMAI	38f457fa-0e95-7298-e063-6394a90adda8	2025-12-09		Exact identifier application number: M020
Non-Tinted Mineral Sunscreen	ZINC OXIDE	OLGA KLIMOV INC	387b41a4-057f-88af-e063-6394a90adbbe	2025-12-09		Exact identifier application number: M020
Tinted Replenishing Daily Protection	ZINC OXIDE	OLGA KLIMOV INC	387b8ae6-c48b-905c-e063-6394a90a31fb	2025-12-09		Exact identifier application number: M020
Tinted Primer Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	CECILIA EDWARDS	36ea709b-3536-5052-e063-6394a90a48f9	2025-12-09		Exact identifier application number: M020
Age Defying Mineral Protection	TITANIUM DIOXIDE, ZINC OXIDE	MARK SCHWARTZ CLINICAL SKINCARE, INC.	3b028159-f240-2cf2-e063-6294a90a32b5	2025-12-09	Warnings	Exact identifier application number: M020
Ultimate Mineral Protection	ZINC OXIDE	MARK SCHWARTZ CLINICAL SKINCARE, INC.	3b02bf69-b648-56e1-e063-6294a90aeef3	2025-12-09	Warnings	Exact identifier application number: M020
G.M. Collin FPS-SPF 45 UVA-UVB TINTED SUNSCREEN	ZINC OXIDE, TITANIUM DIOXIDE	LABORATOIRES DERMO-COSMETIK INC.	01dcfd14-7a1d-98fa-e063-6294a90a0336	2025-12-09	Warnings	Exact identifier application number: M020
Tinted Primer Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	CECILIA EDWARDS	3aff2074-1514-b5c5-e063-6394a90a7572	2025-12-09		Exact identifier application number: M020
Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER	3729d270-64ac-4d2e-e063-6294a90aeb2c	2025-12-09		Exact identifier application number: M020
Non Tinted Replenishing Daily Protection	ZINC OXIDE	LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER	372a41f6-40f6-4971-e063-6394a90a83e0	2025-12-09		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