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 150 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RECHARGE Protect Blur	TITANIUM DIOXIDE, ZINC OXIDE	Rodan & Fields Beauty, LLC	c787e3b9-33b1-4c47-95bd-b14cf6558938	2025-12-08	Warnings	Exact identifier application number: M020
Mineral Mist SPF-50	TITANIUM DIOXIDE, ZINC OXIDE	TUBBY TODD	dca54a19-af25-ce47-e053-2a95a90a22db	2025-12-07	Warnings	Exact identifier application number: M020
Inblair Elevate SPF15 Moisturizer	INBLAIR ELEVATE SPF15 MOISTURIZER	Guangzhou Fantesy Biotechnology Co.,Ltd	4567d413-d8cc-677b-e063-6294a90a1a42	2025-12-07	Warnings	Exact identifier application number: M020
HANCHOBIT Radiant Pink Tone Up Sun Cream	TITANIUM DIOXIDE	HANCHOYEANBIOTEC Co.,Ltd.	45685047-166d-8af5-e063-6294a90aa7be	2025-12-07	Warnings	Exact identifier application number: M020
EELHOE Moisturiser Sun Stick	TITANIUM DIOXIDE	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	454004c9-07fa-64ad-e063-6394a90a0c8a	2025-12-06	Warnings	Exact identifier application number: M020
OUHOE Daily Exposure Lightweight Sunscreen	TITANIUM DIOXIDE	Shantou Ouhoe Technology Co., Ltd.	454301b6-21a6-6153-e063-6294a90a1366	2025-12-06	Warnings	Exact identifier application number: M020
OUHOE Cotton Soft Sun Stick	TITANIUM DIOXIDE	Shantou Ouhoe Technology Co., Ltd.	4543a43e-acf7-6759-e063-6394a90a2f53	2025-12-06	Warnings	Exact identifier application number: M020
OUHOE Centella Daily Sun	TITANIUM DIOXIDE	Shantou Ouhoe Technology Co., Ltd.	4544f3a3-8c52-ea54-e063-6394a90a7a9c	2025-12-06	Warnings	Exact identifier application number: M020
EELHOE All Day Light Sunscreen Mist	TITANIUM DIOXIDE	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	45323ca3-c706-dcb5-e063-6394a90a96f7	2025-12-05	Warnings	Exact identifier application number: M020
EELHOE Airy Sunstick	TITANIUM DIOXIDE	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	45328c13-31ae-3bd2-e063-6394a90a814f	2025-12-05	Warnings	Exact identifier application number: M020
Srubs Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	ITW Pro Brands	06c1dc42-5a01-f898-e063-6394a90a1a1a	2025-12-05	Warnings	Exact identifier application number: M020
OUHOE Tinted Sunscreen	TITANIUM DIOXIDE	Shantou Ouhoe Technology Co., Ltd.	4540f542-248d-bcf5-e063-6294a90aabca	2025-12-05	Warnings	Exact identifier application number: M020
No 7 Restore and Renew Multi Action Fragrance Free Day Cream SPF 25	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	BCM Cosmetique SAS	45c7703b-7ab4-2ef2-e063-6294a90a2b46	2025-12-05	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Day Cream Sunscreen Broad Spectrum SPF 25	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	BCM Cosmetique SAS	4645b051-ef5a-521e-e063-6294a90a2404	2025-12-05	Warnings	Exact identifier application number: M020
SPF 50 Mineral Sunscreen bkids	ZINC OXIDE	KAS Direct LLC dba BabyGanics	f717cd89-194b-42e3-a079-24b2903deb29	2025-12-05	Warnings	Exact identifier application number: M020
Sugargirl Set SPF 30 sunscreen shimmer sunscreen mist for the face	HOMOSALATE , OCTOCRYLENE ,OCTISALATE , AVOBENZONE	Longway Technology(Guangzhou)Co.,Ltd.	451b662a-70ed-8ec5-e063-6294a90a005b	2025-12-04	Warnings	Exact identifier application number: M020
Sugargirl SPF 30 sunscreen illuminating stick sunlight	HOMOSALATE ,OCTOCRYLENE ,OCTISALATE , AVOBENZONE	Longway Technology(Guangzhou)Co.,Ltd.	451b71a9-2240-853f-e063-6394a90ac8f4	2025-12-04	Warnings	Exact identifier application number: M020
Poolside Orange Creme SPF 30 SCENTED gel sunscreen	HOMOSALATE,OCTOCRYLENE,OCTISALATE,OCTIONXATE,AVOBENZONE	Longway Technology(Guangzhou)Co.,Ltd.	451b7229-67d1-8b0e-e063-6394a90ab71e	2025-12-04	Warnings	Exact identifier application number: M020
Sugargirl SPF 30 sunscreen illuminating stick solar	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Longway Technology(Guangzhou)Co.,Ltd.	451b7229-67d3-8b0e-e063-6394a90ab71e	2025-12-04	Warnings	Exact identifier application number: M020
Poolside Sun Silk Body Cream SUNGLOW 05 FRAGRANCE Sunscreen SPF 30 body cream	HOMOSALATE, OCTOCRYENE, OCTISALATE, QCTINOXATE, AVOBENZONE	Longway Technology(Guangzhou)Co.,Ltd.	451b86fa-6c1c-a708-e063-6394a90a47a9	2025-12-04	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