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 231 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Seven Thirty Daily Habit Broad Spectrum SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	SAN DIEGO NATURAL SOAP COMPANY	30ca8f9d-b6a5-4af0-9d7b-487212e40e63	2025-02-03	Warnings	Exact identifier application number: M020
Atlanta Acne Specialist Everyday Sunscreen SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	SAN DIEGO NATURAL SOAP COMPANY	3057f8ad-5850-49a0-b44d-3a1da84126e3	2025-02-03	Warnings	Exact identifier application number: M020
TiZO Ultra Zinc SPF 40 (Tinted)	ZINC OXIDE	Fallien Cosmeceuticals, LTD.	2d3faa43-0d78-58de-e063-6294a90a0b17	2025-02-03	Warnings	Exact identifier application number: M020
TiZO Eye Renewal SPF 20 (Non-Tinted)	ZINC OXIDE	Fallien Cosmeceuticals, LTD	2d40099a-2cfa-1d99-e063-6394a90a36a6	2025-02-03	Warnings	Exact identifier application number: M020
JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 ALMOND WD1	HOMOSALATE, OCTISALATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	4ebd7db8-7e6c-46ed-9d0c-6f9f81ea65fe	2025-02-03	Warnings	Exact identifier application number: M020
JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 CARAMEL D16	HOMOSALATE, OCTISALATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	e4466bcb-278a-44bb-a87b-479c14037e76	2025-02-03	Warnings	Exact identifier application number: M020
JJAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 BISQUE MDN4	HOMOSALATE, OCTISALATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	282c72a8-bcfa-417f-a79d-9dcf68858833	2025-02-03	Warnings	Exact identifier application number: M020
JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 EARTH ND18	HOMOSALATE, OCTISALATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	15eae33b-e8f5-4334-8bf9-fa02ed6ff46d	2025-02-03	Warnings	Exact identifier application number: M020
JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 RICH COCOA ND20	HOMOSALATE, OCTISALATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	2e307ca4-9975-47ef-b13f-2cfbcc846719	2025-02-03	Warnings	Exact identifier application number: M020
JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 CAPUCCINO D8	HOMOSALATE, OCTISALATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	08628240-327d-4329-a0ff-fed239dde206	2025-02-03	Warnings	Exact identifier application number: M020
JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 NATURAL LG14	HOMOSALATE, OCTISALATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	768100d6-efd6-4a98-bdb8-2d1561ee356c	2025-02-03	Warnings	Exact identifier application number: M020
JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 IVORY LN18	HOMOSALATE, OCTISALATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	e6f33ec7-691f-4d4b-9086-b981c19f80d3	2025-02-03	Warnings	Exact identifier application number: M020
JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 SUNTAN MDG14	HOMOSALATE, OCTISALATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	784bb8c4-ee3c-4a73-a828-5781f01f621d	2025-02-03	Warnings	Exact identifier application number: M020
Brush On Block SPF 30 Mineral Powder Translucent Zinc Only-Refill	ZINC OXIDE	SPF Ventures, LLC	2d47eb76-e644-4e04-e063-6294a90a93cc	2025-02-03	Warnings	Exact identifier application number: M020
Brush On Block Sun Shine SPF 30 Protective Lip Oil Peony Tint	TITANIUM DIOXIDE/ZINC OXIDE	SPF Ventures LLC	2d490531-af36-87d0-e063-6394a90acf49	2025-02-03	Warnings	Exact identifier application number: M020
YOUR TINTED MOISTURIZER HYDRATING ANTI AGING BROAD SPECTRUM SPF 30	OCTISALATE, OCTINOXATE, OXYBENZONE, AVOBENZONE	Skin Ai, LLC	2d8b7d07-2249-898b-e063-6394a90af6ad	2025-02-01	Warnings	Exact identifier application number: M020
ESSENCE LIGHT SUNSCREEN SPF 50 PA	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	ENGLEWOOD LAB, INC.	f5c79f1a-cecd-2409-e053-2995a90ad06f	2025-01-31	Warnings	Exact identifier application number: M020
RODAN - FIELDS ESSENTIALS Body Sunscreen BROAD SPECTRUM SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Rodan & Fields	67b55df8-9623-4352-b136-b0bc8d1efe02	2025-01-31	Warnings	Exact identifier application number: M020
Oil-Free Daily Hydration SPF 15	OCTINOXATE, AVOBENZONE	Boscia LLC	ec322ae5-ab03-4c7b-9c6d-0bda3327c72a	2025-01-31	Warnings	Exact identifier application number: M020
PAULAS CHOICE HYDRALIGHT SHINE-FREE DAILY MINERAL COMPLEX Broad Spectrum SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Paula's Choice, Inc	b90658d0-e422-4265-a6ee-39c29b6c116a	2025-01-31	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