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		2026-10-27
excluded package	package	61354-084	61354-084-01	I	Inactivated by FDA		2026-10-27

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 265 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MISSHA ALL AROUND VITA C SUNSCREEN	ZINC OXIDE, HOMOSALATE, ETHYLHEXYL SALICYLATE, TITANIUM DIOXIDE	Able C&C Co., Ltd.	1a7ec673-328a-8924-e063-6294a90a2f3d	2024-12-05	Warnings	Exact identifier application number: M020
(Re)Setting Refreshing Mist SPF 40	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	d4d8f28d-cb00-298d-e053-2995a90a10eb	2024-12-05	Warnings	Exact identifier application number: M020
KEYS SOULCARE DAILY MOISTURIZER BROAD SPECTRUM SPF30 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc	2ba71f81-54d0-4955-9bae-2b6e35c9c35f	2024-12-05	Warnings	Exact identifier application number: M020
Cay Skin Isle Glow Body SPF 45	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Cay Skin, Inc.	db5f6bad-65ae-2b05-e053-2a95a90a8569	2024-12-05	Warnings	Exact identifier application number: M020
Cay Skin Isle Glow Face SPF 45	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Cay Skin, Inc.	d91bba06-fd9b-3eb5-e053-2995a90a6124	2024-12-05	Warnings	Exact identifier application number: M020
Whoa Glow broad spectrum spf 30 sunscreen Sheer Bronze shimmer	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc	65de9491-8804-4e3b-90a7-9b253e34b7d3	2024-12-05	Warnings	Exact identifier application number: M020
Whoa Glow broad spectrum spf 30 sunscreen Sheer Champagne shimmer sunlight	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc	499e5352-fcc4-4434-96f2-4375816991c9	2024-12-05	Warnings	Exact identifier application number: M020
Cay Skin Isle Sheen Sunstick SPF 35	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cay Skin, Inc.	288c3aeb-01b2-ce39-e063-6394a90ad04a	2024-12-05	Warnings	Exact identifier application number: M020
Cay Skin MoBay Mineral Sunscreen Drops SPF 30	ZINC OXIDE	Cay Skin, Inc.	288d5456-98f3-a998-e063-6294a90a8366	2024-12-05	Warnings	Exact identifier application number: M020
Solar Moisturizer SPF 30	OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE	Allure Labs, LLC	ef4d54bf-25f5-4261-9d3d-c42b0d892275	2024-12-05	Warnings	Exact identifier application number: M020
Clear Clear Zinc Solar Protection SPF 30	ZINC OXIDE	Allure Labs, LLC	79a3c8e2-c4f2-4c00-8e94-494654ae91a2	2024-12-05	Warnings	Exact identifier application number: M020
LAB SERIES DAY RESCUE DEFENSE BROAD SPECTRUM SPF 35	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OXYBENZONE	Aramis Inc.	8b206b6d-92e4-48bc-a40c-93ffdd635535	2024-12-05	Warnings	Exact identifier application number: M020
Kids Broad Spectrum SPF 35	ZINC OXIDE	Allure Labs, LLC	b72caf9b-46df-f30c-e053-2995a90a9b6d	2024-12-05	Warnings	Exact identifier application number: M020
CBD Blue Light Defense SPF 30	ZINC OXIDE	Allure Labs	b63b99af-2ddb-3535-e053-2a95a90a65d5	2024-12-05	Warnings	Exact identifier application number: M020
AHAVA CC SPF 30	AVOBENZONE, ENSULIZOLE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	AHAVA - Dead Sea Laboratories Ltd	2fa6249a-9614-455c-8e07-9b829f3b0c22	2024-12-04	Warnings	Exact identifier application number: M020
EGF FGF DNA UV SHIELD	ETHYLHEXYL METHOXYCINNAMATE, TITANIUM DIOXIDE, ETHYLHEXYL SALICYLATE	Dermaesthetics Inc.	13e2630d-9915-4287-91fd-deb672150131	2024-12-04	Warnings	Exact identifier application number: M020
SUNSCREEN 01	AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	e98c3b64-edcb-16c7-e053-2a95a90a8a0e	2024-12-04	Warnings	Exact identifier application number: M020
Sun ,Bug Handsfree 01	AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	f8f29aec-935f-e828-e053-6394a90a570a	2024-12-04	Warnings	Exact identifier application number: M020
sunscreen 01	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	e9e3ecc1-3f13-1d0e-e053-2a95a90ac7f8	2024-12-04	Warnings	Exact identifier application number: M020
MISSHA M Perfect Cover BB No 13	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE	Able C&C Co., Ltd.	95846b5e-5b72-26bc-e053-2a95a90ae0f7	2024-12-04	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