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 236 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Black Girl Sunscreen SPF 50 broad Spectrum	AVOBENZONE, HOMOSALATE, OCTISALATE	Black Girl Sunscreen, LLC	2bc471f0-c93e-0c51-e063-6394a90a77f0	2025-01-15	Warnings	Exact identifier application number: M020
Black Girl Sunscreen SPF 45	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Black Girl Sunscreen, LLC	2bc4b1b1-5f19-7ba3-e063-6394a90a5de7	2025-01-15	Warnings	Exact identifier application number: M020
Black Girl Sunscreen Sunscreen SPF 30 broad Spectrum	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Black Girl Sunscreen, LLC	2bc4c639-787a-d2d3-e063-6394a90a5ded	2025-01-15	Warnings	Exact identifier application number: M020
Black Girl Sunscreen Sunscreen SPF 30 broad Spectrum	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Black Girl Sunscreen, LLC	2bc4d937-77d0-273c-e063-6394a90a25e7	2025-01-15	Warnings	Exact identifier application number: M020
Black Girl Sunscreen Sunscreen SPF 30 broad Spectrum	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Black Girl Sunscreen, LLC	2bc4cfd9-e44c-9b93-e063-6394a90a96a6	2025-01-15	Warnings	Exact identifier application number: M020
Black Girl Sunscreen Sunscreen SPF 30 broad Spectrum	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Black Girl Sunscreen, LLC	2bc4e22d-6265-9c0b-e063-6394a90a1541	2025-01-15	Warnings	Exact identifier application number: M020
Black Girl Sunscreen Sunscreen SPF 30 broad Spectrum	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Black Girl Sunscreen, LLC	2bc4eb32-8c0b-32fc-e063-6294a90a1625	2025-01-15	Warnings	Exact identifier application number: M020
Black Girl Sunscreen Sunscreen SPF 30 broad Spectrum	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Black Girl Sunscreen, LLC	2bc50182-30f2-b77e-e063-6394a90a6355	2025-01-15	Warnings	Exact identifier application number: M020
Black Girl Sunscreen Sunscreen SPF 30 broad Spectrum	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Black Girl Sunscreen, LLC	2bc50182-30f5-b77e-e063-6394a90a6355	2025-01-15	Warnings	Exact identifier application number: M020
MEDIFORDEAR CICA CALMING SUNSCREEN	HOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, AVOBENZONE	Youngwon Costech Co.,ltd.	2bc94923-b221-5159-e063-6394a90ab8ff	2025-01-15	Warnings	Exact identifier application number: M020
Meaningful Beauty Cindy Crawford Anti-Aging Day Creme with Environmental Protection Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OXYBENZONE	Meaningful Beauty, LLC	6423e1c7-85cd-46f8-8fc9-a7284e3577d1	2025-01-15	Warnings	Exact identifier application number: M020
Stay AgelessTinted Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	Spectrum Aesthetics Laser Training LLC	026b9b30-ef08-bf2e-e063-6394a90a54a6	2025-01-14	Warnings	Exact identifier application number: M020
Daily Sunscreen Broad Spectrum SPF 30 UVA UVB	MINERAL SUNSCREEN SPF 30	IHerb, LLC	2d8101ef-96a3-1463-e063-6294a90add4d	2025-01-14	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Tinted Mineral Sunscreen Face Stick Unscented SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0d85b0a1-3705-2829-e063-6394a90a0ed7	2025-01-13	Warnings	Exact identifier application number: M020
Attitude mineral sunscreen orange blossom SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0b85ea68-6113-4e92-a10a-39d13099d12d	2025-01-13	Warnings	Exact identifier application number: M020
Skinfuse Shield SPF 30	ZINC OXIDE	Owen Biosciences, Inc.	02d46d44-2476-4f96-9c72-783c392317de	2025-01-13		Exact identifier application number: M020
Chem Free SPF 30	ZINC OXIDE	Owen Biosciences, Inc.	7e5930fe-eb0f-4a21-8065-8831dd5b351c	2025-01-13	Warnings	Exact identifier application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 Shell	ZINC OXIDE	EVER FAME PTE. LTD.	2b9b5a73-858e-78dd-e063-6394a90ad082	2025-01-13	Warnings	Exact identifier application number: M020
Tula Skincare protect and go dewy glow sunscreen stick broad spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	2b9acb63-b32c-336c-e063-6394a90a4a9c	2025-01-13	Warnings	Exact identifier application number: M020
Brush and Go All Skin types	TITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONE	Noon Aesthetics M.R. Ltd	9ee5b3c2-4369-4c4b-ab55-b52661b82188	2025-01-13	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