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		2026-10-30
excluded package	package	61354-084	61354-084-01	I	Inactivated by FDA		2026-10-30

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 280 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Market Basket Continuous Sunscreen General Protection SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENE	DEMOULAS SUPER MARKETS, INC.	e7182d07-a006-db4b-e053-2995a90aa9e1	2024-10-17	Warnings	Exact identifier application number: M020
EXCHANGE SELECT SPORT SUNSCREEN CONTINUOUS SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Army & Air Force Exchange Service	e467df80-9007-46c9-e053-2a95a90a1bef	2024-10-17	Warnings	Exact identifier application number: M020
EXCHANGE SELECT KIDS SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Army & Air Force Exchange Service	e467c306-a2ed-4976-e053-2995a90a56ed	2024-10-17	Warnings	Exact identifier application number: M020
Exchange Select Sport Sunscreen Continuous SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENE	Army & Air Force Exchange Service	e716ba8c-0148-07f2-e053-2a95a90a53df	2024-10-17	Warnings	Exact identifier application number: M020
EXCHANGE SELECT SPORT SUNSCREEN CONTINUOUS SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Army & Air Force Exchange Service	f55828b4-f2a4-13ec-e053-2995a90a0f84	2024-10-17	Warnings	Exact identifier application number: M020
SPF50 Plus Mineral Sunscreen	ZINC OXIDE AND TITANIUM DIOXIDE	KAS Direct LLC dba BabyGanics	08e8bc10-85d8-4215-8351-7ec12029416c	2024-10-17	Warnings	Exact identifier application number: M020
bu SPF 30 Broad Spectrum Alcohol-Free Performance Sunscreen - Natural Citrus Scent	OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Bu Brands, LLC	9ac92c96-5bcf-421d-9cd0-73ddfa10195c	2024-10-17	Warnings	Exact identifier application number: M020
bu SPF 30 Broad Spectrum on Alcohol-Free Performance Sunscreen - Fragrance Free	OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Bu Brands, LLC	20b32aae-7f8b-44ed-a3df-706054fd6883	2024-10-17	Warnings	Exact identifier application number: M020
bu SPF 30 Broad Spectrum Alcohol-Free Performance Sunscreen - Natural White Sage Scent	OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Bu Brands, LLC	d77be4d0-c08a-4d81-b5df-a9bae38e3b97	2024-10-17	Warnings	Exact identifier application number: M020
FOTE CABANA BEACH CLUB WITH BLOOD ORANGE AND ESSENTIAL OILS SPF 8 DRY TANNING SUNSCREEN	HOMOSALATE, OCTISALATE	FRUIT OF THE EARTH, INC.	13325a2a-f7f8-4019-acbb-205fd5dd13a5	2024-10-17	Warnings	Exact identifier application number: M020
FOTE CABANA BEACH CLUB WITH MANUKA HONEY AND ESSENTIAL OILS SPF 30 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	FRUIT OF THE EARTH, INC.	ae7951e9-54f6-4eab-81b6-a2b2c978851d	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Cabana Beach Clubwith Blood Orange and Essential Oils SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c7805f3c-5b95-73bd-e053-2a95a90a9984	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Cabana Beach Club with Manuka Honey and Essential Oils SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c7820ba9-7520-5139-e053-2a95a90ab92d	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Cabana Beach Club with Blood Orange and Essential Oils SPF 30	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c7916317-c6a2-2eda-e053-2995a90a1628	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Cabana Beach Club with Mentha and Essential Oils SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c790031d-5448-a998-e053-2a95a90a763e	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of The Earth Sun Town City Kids SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c79472ea-a367-1328-e053-2a95a90a22d5	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City Dark Tanning Dry Oil SPF 8 Sunscreen	HOMOSALATE, OCTISALATE	Fruit of the Earth, Inc.	c7a94f68-a4d5-ec82-e053-2995a90a38fb	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City Baby SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c7ba72c2-ea23-0bb9-e053-2a95a90a1d90	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c795cd2f-89dc-78e3-e053-2a95a90a9422	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c7a4783f-477f-1524-e053-2995a90a5ad9	2024-10-17	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