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 237 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Priia Tinted Mineral Sunscreen and Primer	TITANIUM DIOXIDE, ZINC OXIDE	Priia Cosmetics Inc	5c4219ac-d65f-43a5-8ec4-8732b9b344cf	2025-01-13	Warnings	Exact identifier application number: M020
Brush and Go Oily Problematic Skin	TITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONE	Noon Aesthetics M.R. Ltd	b4295453-f193-4bed-be5b-efcd91772107	2025-01-13	Warnings	Exact identifier application number: M020
Zealios SPF LipGuard	OCTISALATE AND AVOBENZONE	Personal Best Products Inc. dba Zealios	3a07822b-a7c9-40af-a8f7-bea591c7a49b	2025-01-13	Warnings	Exact identifier application number: M020
SPF-30 BB	ZINC OXIDE	ZION HEALTH	66d33d8c-8900-4698-98fe-0dedafe674d8	2025-01-13	Warnings	Exact identifier application number: M020
Priia Tinted Mineral Sunscreen and Primer	TITANIUM DIOXIDE, ZINC OXIDE	Priia Cosmetics Inc	b2addf27-9139-48b4-85e6-618f4b5311cc	2025-01-13	Warnings	Exact identifier application number: M020
Skin Apeel Ageless Defense SPF 40 Broad Spectrum	ZINC OXIDE	Skin Apeel, Inc.	c3bbe779-b012-4f19-8b90-2c7a4dd88617	2025-01-13	Warnings	Exact identifier application number: M020
UNCOMPLIKATED MAKEUP SETTING SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	KATE SOMERVILLE SKINCARE LLC	1a33cb41-440a-41cb-9832-24255bfa2b7c	2025-01-12	Warnings	Exact identifier application number: M020
ALLSWELL MINERAL SUNSCREEN SPF 30	ZINC OXIDE	Stream2Sea, LLC	03bee988-d6e3-4290-a926-9c5366649cba	2025-01-12	Warnings	Exact identifier application number: M020
Baby Donna SHeer SPF Sunscreen Stick	ZINC OXIDE	Stream2Sea, LLC	a1b1cdeb-e5fe-4ba1-8bb0-3c7a97dd93fe	2025-01-12	Warnings	Exact identifier application number: M020
SUN PROTECT LIP BALM SPF 30	ZINC OXIDE AND TITANIUM DIOXIDE	Stream2Sea, LLC	21386652-b952-48be-b077-1acecc7f0eb0	2025-01-12	Warnings	Exact identifier application number: M020
Equate Beauty Daily Moisturizer SPF-30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	Wal-Mart Stores, Inc.	00abd6d0-c467-4885-80fe-b062622147d7	2025-01-10	Warnings	Exact identifier application number: M020
Bondi Sands SPF 60 Sunny Body	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	BONDI SANDS (USA) INC.	2b5aebed-49f6-7bb8-e063-6294a90a8521	2025-01-10	Warnings	Exact identifier application number: M020
Bondi Sands SPF 60 Sunny Drops Face Serum	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	BONDI SANDS (USA) INC.	2b5c69e4-2819-94ef-e063-6394a90a68e7	2025-01-10	Warnings	Exact identifier application number: M020
Dermaroller Anhydrous Sunscreen SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Owen Biosciences, Inc.	04e82f1b-c893-4795-b7a9-0523e3ec7552	2025-01-10	Warnings	Exact identifier application number: M020
Skinfuse Shield SPF 30	ZINC OXIDE	Owen Biosciences, Inc.	b8e4c11a-4b4f-4e36-a75e-0a73913113d5	2025-01-10	Warnings	Exact identifier application number: M020
Correct and Protect Serum Broad Spectrum SPF 45	ZINC OXIDE	Murad, LLC	60c62108-6806-4722-a44b-f1c300d59c1e	2025-01-10	Warnings	Exact identifier application number: M020
Multi Vitamin Clear Coat Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Murad, LLC	e023c874-c89d-4bd0-a0b9-a8161c261457	2025-01-10	Warnings	Exact identifier application number: M020
CoTZ Baby	ZINC OXIDE	Fallien Cosmeceuticals, LTD	17cc12c7-5af8-413f-b205-31ac150583e2	2025-01-09	Warnings	Exact identifier application number: M020
ISNTREE HYALURONIC ACID DAILY SUNGEL	AVOBENZONE, HOMOSALATE, OCTISALATE	ISNTREE Inc.	2b3bdbe1-ede9-cd60-e063-6394a90ab2f3	2025-01-09	Warnings	Exact identifier application number: M020
JAFRA ROYAL REVITALIZE 4 TUBE SET	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Distribuidora Comercial Jafra, S.A. de C.V.	b4a0d6ab-50a7-43e7-9d7e-a4c01d7eca98	2025-01-09	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