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		2026-10-23
excluded package	package	61354-084	61354-084-01	I	Inactivated by FDA		2026-10-23

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 234 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	Z&Z Skin Essentials	2cdc48f3-474f-9c06-e063-6294a90afea1	2025-01-27	Warnings	Exact identifier application number: M020
Cetaphil Sheer Mineral Sunscreen Stick SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Galderma Laboratories, L.P.	54f6df65-e90c-4070-aa95-f47496dd11bd	2025-01-27	Warnings	Exact identifier application number: M020
Cetaphil Healthy Renew Day Cream Broad Spectrum SPF 30	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Galderma Laboratories, L.P.	5b4e25ad-cd72-4960-9259-fc710bfd59da	2025-01-27	Warnings	Exact identifier application number: M020
Well People Daygleamer Liquid Mineral Sunscreen SPF 34	ZINC OXIDE	e.l.f. Cosmetics, Inc.	2c7621e9-0f1d-4712-e063-6294a90abd64	2025-01-24	Warnings	Exact identifier application number: M020
Equate Sunscreen SPF 30 SPORT Broad Spectrum	AVOBENZONE, HOMOSALATE,OCTISALATE,OCTOCRYLENE	Wal-Mart Stores Inc	1697628a-91d2-45bc-bd1b-91fb38f3f8df	2025-01-24	Warnings	Exact identifier application number: M020
DR.JART EVERY SUN DAY SUN FLUID	HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	Have & Be Co., Ltd.	f06d8f90-f3df-6d76-e053-2a95a90af1f8	2025-01-24	Warnings	Exact identifier application number: M020
CoTZ Silky Foam - Tinted	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	d63088d7-a1d7-4b56-a7d8-ad217011a8a8	2025-01-24	Warnings	Exact identifier application number: M020
CoTZ Silky Foam Non-Tinted	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	9c04b76e-ae65-4183-b475-3b8e8764db59	2025-01-24	Warnings	Exact identifier application number: M020
natural lip balm SPF15(unflavored) 01	AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	2c5a460a-dc93-14cc-e063-6294a90a0b61	2025-01-23	Warnings	Exact identifier application number: M020
360 by QUR Lemon Verbena lip balm	OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Qur, Inc	bedb14c2-9181-5970-e053-2a95a90a4161	2025-01-23	Warnings	Exact identifier application number: M020
Soleo Organics Sunscreen	ZINC OXIDE	SE Operations Pty Ltd	59ea43e3-f6e6-4d10-9d8f-2f14eaf2f79b	2025-01-22	Warnings	Exact identifier application number: M020
Neptune Ave. High Dive Barrier Repair Moisturizer Broad Spectrum SPF 50	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Neptune Ave. Inc.	25034563-6420-daf6-e063-6394a90af980	2025-01-22	Warnings	Exact identifier application number: M020
Jafra Sun body protector sunscreen broad spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Distribuidora Comercial Jafra, S.A. de C.V.	b8e49dd6-305c-f717-e053-2995a90a659c	2025-01-22	Warnings	Exact identifier application number: M020
Jafra Royal Defy Sample Kit	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Distribuidora Comercial Jafra, S.A. de C.V.	c3b265b1-ab84-4ea9-b283-c92f5a4cf461	2025-01-22	Warnings	Exact identifier application number: M020
SUNSCREEN BROAD SPECTRUM SPF 50 FACE AND BODY	AVOBENZONE/OCTISALATE/OCTOCRYLENE	Mary Kay Inc.	2c4eaf2e-b034-8185-e063-6394a90a8275	2025-01-22	Warnings	Exact identifier application number: M020
Herbalife SKIN Protective Moisturizer Broad Spectrum SPF 30 Mineral Sunscreen	ZINC OXIDE	Herbalife International of America Inc.	d30b7cf1-73bb-3568-e053-2995a90ad579	2025-01-21	Warnings	Exact identifier application number: M020
Herbalife Herbal Aloe Face and Body Mineral Sunscreen Broad Spectrum SPF 30	ZINC OXIDE	Herbalife International of America, Inc.	d30d9d02-bc31-db3c-e053-2a95a90a0dab	2025-01-21	Warnings	Exact identifier application number: M020
Sugargirl Disco Stick SPF 30	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	36f30834-62be-4076-9493-f385720a1e22	2025-01-20	Warnings	Exact identifier application number: M020
Sugargirl Glowy Face Screen Shimmer Sunscreen SPF 30	HOMOSALATE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, AVOBENZONE	I World LLC	757897b0-fc65-4147-8444-2a0efdc6f81c	2025-01-20	Warnings	Exact identifier application number: M020
Sugargirl Hot Body Screen Shimmer Sunscreen SPF 30	HOMOSALATE, OCTOCRYLENE, OCTINOXATE, AVOBENZONE, OCTISALATE	I World LLC	a9bf1342-1c4b-48ad-a955-715647df125a	2025-01-20	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