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		2026-10-21
excluded package	package	61354-084	61354-084-01	I	Inactivated by FDA		2026-10-21

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 190 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dolce and Gabbana Everlast Foundation SPF 20 38C Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	0358a87d-8002-4f3e-851a-3a582d356edf	2025-09-03	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 39N Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	34dfc4c5-44f7-4531-97ba-8846ebe14724	2025-09-03	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 40C Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	cf4b6f45-d4ae-4665-87b4-c5af4910befa	2025-09-03	Warnings	Exact identifier application number: M020
DOLCE and GABBANA MEET YOUR FLAWLESS MATTE SKIN DUO - EVERLAST PRIMER EVERLAST FOUNDATION	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	DOLCE & GABBANA BEAUTY SRL	eb63e9c6-bdb0-4bdf-8822-e4561a56adc9	2025-09-03	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 1N Light	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	9507681c-236c-41c1-9dc9-ed4c0c091741	2025-09-03	Warnings	Exact identifier application number: M020
Pure6 ManiShield Hand Screen	ZINC OXIDE, TITANIUM DIOXIDE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	3abcb6ba-1de8-55e7-e063-6294a90aecf1	2025-09-02	Warnings	Exact identifier application number: M020
Round Lab Dodo s Pick Bestseller Set	AVOBENZONE, HOMOSALATE, OCTISALATE	SEORIN COMPANY Co., Ltd.	3dd3db99-2e9f-16fc-e063-6294a90adda1	2025-09-02	Warnings	Exact identifier application number: M020
Sun Bum Premium Sunscreen Face Stick Broad Spectrum SPF 30 Sunscreen - Pegged	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3d86da52-6354-f53e-e063-6394a90aac55	2025-09-02	Warnings	Exact identifier application number: M020
Sheer Guard Natural Mineral Sunscreen Broad Spectrum SPF 50	ZINC OXIDE	Baxter Laboratories Pty	3dd711c1-7758-31da-e063-6294a90a4f38	2025-09-02	Warnings	Exact identifier application number: M020
Sun Bum Road Tripper Mineral - Mineral Sunscreen Broad Spectrum SPF 30	ZINC OXIDE	Sun Bum, LLC	3dd7b0af-dc37-1701-e063-6294a90a65c3	2025-09-02	Warnings	Exact identifier application number: M020
toty Ilumina CC Creamy Compact 6N	TITANIUM DIOXIDE	Chipican LLC	3da732e7-19b0-3195-e063-6394a90a9a0c	2025-09-01	Warnings	Exact identifier application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 4	ENSULIZOLE ,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDE	Hangzhou Jingshen Trading Co., Ltd.	3dba1360-f70f-e450-e063-6394a90a8c9f	2025-09-01	Warnings	Exact identifier application number: M020
TOCOBO Cotton Airy Sun Stick	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	PICTON CO., Ltd.	2f7e7ef4-c3ac-4c26-e063-6394a90a9e42	2025-09-01	Warnings	Exact identifier application number: M020
TOCOBO Bio Watery Sun Screen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	PICTON CO., Ltd.	3a7db6f4-66fd-4473-e063-6394a90a886e	2025-09-01	Warnings	Exact identifier application number: M020
TOCOBO Bio Watery Sun Screen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	PICTON CO., Ltd.	2f7eb413-ff49-711d-e063-6394a90ad6dc	2025-09-01	Warnings	Exact identifier application number: M020
Ocean Potion Suncare Mineral 30 Essential Scent of Sunshine Zinc Oxide Sunscreen	ZINC OXIDE	GNL BRANDS INTERNATIONAL, LLC	3db1cf3e-0640-6821-e063-6294a90a7036	2025-08-31	Warnings	Exact identifier application number: M020
Purpose Dual Treatment SPF 10	OCTINOXATE 7.5%, OCTISALATE 5%, OXYBENZONE 3%	Elysium Consumer Healthcare LLC	3d7fe711-a671-df30-e063-6394a90afbbf	2025-08-29	Warnings	Exact identifier application number: M020
Good Weather Skin The One Daily Sun Warm Glow SPF 30	ZINC OXIDE	Good Weather Inc.	3d83aaa5-0e4e-928a-e063-6294a90a24da	2025-08-29	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 33N Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	e249507c-d536-4c1d-a99d-857ca1e833d8	2025-08-29	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 32W Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	ba99edea-bf68-4118-8bb7-ea40322db46a	2025-08-29	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