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 263 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SUNLEYA Age minimizing sun care SPF 15	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	C.F.E.B. Sisley	67498d45-0871-4806-8854-81d3e50c4b90	2024-12-10	Warnings	Exact identifier application number: M020
SUPER CREME SOLAIRE CORPS Body sun care SPF 15	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	C.F.E.B. Sisley	1c774aa7-8963-4221-b4b0-b894bd1b941f	2024-12-10	Warnings	Exact identifier application number: M020
Tinted Sunscreen Cream SPF 30 4-Deep Amber	TITANIUM DIOXIDE, ZINC OXIDE	C.F.E.B. - Sisley	5599922a-b020-477c-a44c-1db42ec5756a	2024-12-10	Warnings	Exact identifier application number: M020
SUNLEYA Age minimizing sun care SPF 50 plus	AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE	C.F.E.B. Sisley	7c9fadaf-b961-4df0-89ae-87141b50b2c1	2024-12-10	Warnings	Exact identifier application number: M020
Tinted Sunscreen SPF 30 1-Natural	TITANIUM DIOXIDE, ZINC OXIDE	C.F.E.B. - Sisley	b3d53a10-2647-492a-a05f-b97c3f716aa8	2024-12-10	Warnings	Exact identifier application number: M020
Tinted Sunscreen SPF 30 2-Golden	TITANIUM DIOXIDE, ZINC OXIDE	C.F.E.B. - Sisley	389cbce6-552c-4633-babd-7b672632f0b9	2024-12-10	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	28f08236-1f01-d759-e063-6294a90adcfa	2024-12-10	Warnings	Exact identifier application number: M020
Blistex Five Star Lip Protection Broad Spectrum	HOMOSALATE, OCTISALATE, AVOBENZONE, AND DIMETHICONE	Blistex Inc.	47b57317-7df5-442e-a3a4-1d44fe278ac6	2024-12-10	Warnings	Exact identifier application number: M020
AHAVA Brightening Broad Spectrum SPF 20	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	AHAVA - Dead Sea Laboratories Ltd	724bbb91-e273-4926-9ad6-a1657ffe4cd8	2024-12-10	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Mineral Sunscreen Stick Unscented SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0d83c576-5dfb-583a-e063-6294a90a2a28	2024-12-09	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Kids Mineral Sunscreen Face Stick Unscented SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0d833e3b-5330-3c5b-e063-6394a90a2ed2	2024-12-09	Warnings	Exact identifier application number: M020
ATTITUDE Oatmeal Sensitive Natural Mineral Sunscreen Stick Unscented SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0d9533ba-5606-4116-e063-6294a90ad3b1	2024-12-09	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Kids Mineral Sunscreen Stick Unscented SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0d82121d-1dc2-cd99-e063-6394a90aa766	2024-12-09	Warnings	Exact identifier application number: M020
Attitude Kids Oatmeal sensitive mineral sunscreen unscented SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	310e66a2-8714-4016-87f4-81c1fef19ec9	2024-12-09	Warnings	Exact identifier application number: M020
Attitude Oatmeal sensitive mineral sunscreen unscented SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	b6b8733d-6431-4ed2-9350-c63bb901c804	2024-12-09	Warnings	Exact identifier application number: M020
BIO SPECTRA ATTITUDE	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	06245c8c-93e8-4ebb-bab0-3db64dc178b9	2024-12-09	Warnings	Exact identifier application number: M020
BANANA BOAT KIDS SPF 65 CLEAR SUNSCREEN	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	dc7b0d17-d7c8-433f-e053-2995a90a477d	2024-12-09	Warnings	Exact identifier application number: M020
Sheer Zinc SPF 30	ZINC OXIDE	Allure Labs	b6b45dac-41d0-1b55-e053-2a95a90acf61	2024-12-09	Warnings	Exact identifier application number: M020
Broad Spectrum SPF30 Mineral Sunscreen	ZINC OXIDE	Allure Labs	dafc8e62-7c99-1f6d-e053-2995a90a7791	2024-12-09	Warnings	Exact identifier application number: M020
Prevention Daily Tinted Moisturizer SPF 30	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs	ed883d63-777c-e924-e053-2995a90a162a	2024-12-09	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