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 153 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ATTITUDE Super leaves Lip Balm SPF 15 Watermelon	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	450dcc02-8bcb-6c07-e063-6394a90a5df4	2025-12-03	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Mineral Sunscreen Face Stick SPF 50 Unscented	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	44acf513-ffe6-888c-e063-6394a90a9c5c	2025-12-03	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Baby Mineral Sunscreen Face Stick SPF 50 Unscented	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	450e52a9-5a6b-112f-e063-6394a90af7ca	2025-12-03	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Kids Mineral Sunscreen Face Stick SPF 50 Unscented	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	450e6eb7-f49e-296e-e063-6294a90a05a4	2025-12-03	Warnings	Exact identifier application number: M020
Attitude - Leaves Bar - Lip Balm - SPF 15 - Mango	ZINC OXIDE	9055-7588 Qubec Inc. DBA Attitude	359a7ebf-46a6-4e99-b43c-f585e9bc08d9	2025-12-03	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Lip balm Unscented SPF 15	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0d95a2b7-288d-7b29-e063-6294a90ae46b	2025-12-03	Warnings	Exact identifier application number: M020
Attitude - Lip Balm - SPF 15 - Coconut	ZINC OXIDE	Attitude DBA 9055-7588 Qubec Inc.	068af2ec-a666-45bf-b0e0-89d1b93dedf1	2025-12-03	Warnings	Exact identifier application number: M020
Cancer Council Invisible Fluid SPF50 Plus	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Vitality US Co.	1629b02b-e9f3-0593-e063-6294a90a9aa5	2025-12-03	Warnings	Exact identifier application number: M020
PRO-TECT SPORTS SUNSCREEN	MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE	Bio-Medical & Pharmaceutical Manufacturing Corporation	16994959-cade-06de-e054-00144ff88e88	2025-12-03	Warnings	Exact identifier application number: M020
PRO-TECT SPORTS SUNSCREEN	MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE	Bio-Medical & Pharmaceutical Manufacturing Corporation	66bb06fb-33d2-4b57-a65f-66bcd187c627	2025-12-03	Warnings	Exact identifier application number: M020
PRO-TECT SUNSCREEN FOR PROFESSIONALS	MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE	Bio-Medical & Pharmaceutical Manufacturing Corporation	374e172b-90e8-4fca-8934-dee3ed7b599d	2025-12-03	Warnings	Exact identifier application number: M020
LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 BERRY UNIVERSEL	OCTINOXATE, ZINC OXIDE	BEL STAR S A	25b6cb46-6516-376a-e063-6394a90a44f6	2025-12-03	Warnings	Exact identifier application number: M020
LBEL LUMI AGE ANTI AGING NOURISHING FACIAL WITH SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	BEL STAR SA	4510cd0d-40b8-f452-e063-6394a90a44e5	2025-12-03	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	45117885-c674-b58a-e063-6394a90af5f4	2025-12-03	Warnings	Exact identifier application number: M020
CANNON BALM	OCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	DUKE CANNON SUPPLY CO.	f70a0173-c8ba-da7c-e053-6294a90a67db	2025-12-03	Warnings	Exact identifier application number: M020
Radically Rejuvenating SPF Day Cream	ZINC OXIDE	Better Planet Brands LLC	1d8c8600-f2d1-6e12-e063-6294a90ab88a	2025-12-03	Warnings	Exact identifier application number: M020
Seriously Soothing SPF Day Cream	ZINC OXIDE	Better Planet Brands LLC	1d8d47f6-907d-ab31-e063-6394a90a05d8	2025-12-03	Warnings	Exact identifier application number: M020
Invisible Sunscreen Stick SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Better Planet Brands LLC	1d8df35e-0af6-36f6-e063-6394a90a0f03	2025-12-03	Warnings	Exact identifier application number: M020
Sun Serum Drops	ZINC OXIDE	Better Planet Brands LLC	2cdb97bf-a4d7-1cb7-e063-6394a90ab2b8	2025-12-03	Warnings	Exact identifier application number: M020
Mineral Sunscreen SPF 50	ZINC OXIDE	Better Planet Brands LLC	1d8e727c-8b50-9cf2-e063-6394a90a2e15	2025-12-03	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