Cream

Product NDC: 61354-083
11-digit product format: 613540083
Labeler code: 61354
Product ID: 61354-083_e7757228-2748-0ae5-e053-2a95a90ac31c
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	61354-083		I	Inactivated by FDA		2026-10-15
excluded package	package	61354-083	61354-083-01	I	Inactivated by FDA		2026-10-15

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	61354-083-01	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	61354-083-01	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	61354-083-01	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	61354-083-01	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	61354-083-01	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	61354-083-01	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	61354-083-01	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	61354-083-01	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	61354-083-01	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
61354-083-01	2025-01-30	C162847	48780-1	2cef2736-615a-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
61354-083-01	Cream	100 mg in 1 TUBE	CREAM	100		1
61354-083-01	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
61354-083	CREAM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [OXYGEN DEVELOPMENT LLC]	1	Legacy NDC, 2 package rows	20220831_e7757228-2747-0ae5-e053-2a95a90ac31c.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 21 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FUTURIST HYDRATING COLLAGEN-PEPTIDE MAKEUP BROAD SPECTRUM SPF 20	OCTINOXATE AND TITANIUM DIOXIDE	ESTEE LAUDER INC	53d9d689-4a86-5b9c-e063-6394a90aef18	2026-06-09	Warnings	Exact identifier application number: M020
TERRA LOTUS SPF 50 ORGANIC TALLOW SUNSCREEN	ZINC OXIDE	Moes Group LLC	53c09714-6137-7102-e063-6294a90a72a4	2026-06-08	Warnings	Exact identifier application number: M020
TITAN TALLOW SPF 50 ORGANIC TALLOW SUNSCREEN	ZINC OXIDE	Moes Group LLC	53c13cc3-208e-ae7d-e063-6294a90a2a03	2026-06-08	Warnings	Exact identifier application number: M020
Innisfree Daily UV Defense Mineral Sunscreen	ZINC OXIDE LOTION	Innisfree Corporation	0e9cd3e5-cff8-7594-e063-6394a90aad90	2026-06-08	Warnings	Exact identifier application number: M020
Paulas Choice Lipscreen Broad Spectrum SPF 50	OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE	Cosmetic Solutions LLC	4c37e10c-3da5-4a48-b2c1-1b99ce9a02c1	2026-06-08	Warnings	Exact identifier application number: M020
Eryfotona Ageless Tinted Lightweight Emulsion Sunscreen	TITANIUM DIOXIDE	ISDIN Corp.	293a1116-e8a2-495f-83db-20dd82ed13c2	2026-06-08	Warnings	Exact identifier application number: M020
Inflair Elevate SPF15 Moisturizer	ETHYLHEXYL METHOXYCINNAMATE ETHYLHEXYL SALICYLATE HOMOSALATE BUTYL METHOXYDIBENZOYLMETHANE	Guangzhou Yapheon Health Industry Co., Ltd	53a724e9-229e-eea4-e063-6294a90a7d5e	2026-06-07	Warnings	Exact identifier application number: M020
Eryfotona Actinica Tinted	TITANIUM DIOXIDE	ISDIN Corp.	97357703-0e93-4216-bd1b-a9b202781959	2026-06-05	Warnings	Exact identifier application number: M020
Invisible Fit Sun Cream	TITANIUM DIOXIDE	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	537cb611-52f4-13a5-e063-6294a90a9f2a	2026-06-05	Warnings	Exact identifier application number: M020
Matte Invisible Mineral Sunscreen	ZINC OXIDE	INTEGRATIVE AESTHETICS BOSTON, LLC	538429b8-4f0e-e825-e063-6294a90a5905	2026-06-05	Warnings	Exact identifier application number: M020
Matte Invisible Mineral Sunscreen Non-Tinted	ZINC OXIDE	INTEGRATIVE AESTHETICS BOSTON, LLC	5384da3c-4017-a3c1-e063-6294a90ae9a3	2026-06-05	Warnings	Exact identifier application number: M020
MEDULTIMA ADVENTURE SUNSCREEN	HOMOSALATE,OCTOCRYLENE, PHENYLBENZIMIDAZOLE SULFONIC ACID, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANE	Guangzhou Tata Biotechnology Co., Ltd.	5368b2b3-fd80-9659-e063-6394a90a0ad3	2026-06-04	Warnings	Exact identifier application number: M020
WEN SixThirteen SPF 20 Dry Oil Intensive Treatment	OCTOCRYLENE, HOMOSALATE, ETHYLHEXYL METHOCINNAMATE, ETHYLHEXYL SALICYLATE, BENZOPHENONE	WEN by Chaz Dean	536e6291-f5ca-37a4-e063-6394a90adfdb	2026-06-04	Warnings	Exact identifier application number: M020
Mineral Mattescreen SPF 40 - Untinted	TITANIUM DIOXIDE, ZINC OXIDE	Supergoop, LLC	08671d39-3be2-d666-e063-6294a90a6207	2026-06-04	Warnings	Exact identifier application number: M020
Mineral Mattescreen SPF 40 - Golden Hour	TITANIUM DIOXIDE, ZINC OXIDE	Supergoop, LLC	c2398820-f003-707f-e053-2a95a90a6929	2026-06-04	Warnings	Exact identifier application number: M020
Glow Gloss Lip Balm SPF 40 Vanilla Soft Serve	HOMOSALATE, OCTOCRYLENE, AVOBENZONE, OCTISALATE	Supergoop!	26d2897f-46a7-52b2-e063-6394a90aed32	2026-06-04	Warnings	Exact identifier application number: M020
Epionce Daily Shield Tinted SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Episciences, Inc.	3d1e2921-cba9-4446-e054-00144ff8d46c	2026-06-04	Warnings	Exact identifier application number: M020
Abib No White Cast SPF Gift Set	HOMOSALATE, OCTOCRYLENE,OCTISALATE,AVOBENZONE	FOURCOMPANY CO., LTD.	537420bb-9fd8-0649-e063-6394a90aa8cf	2026-06-04	Warnings	Exact identifier application number: M020
Airy sunstick smooting bar	HOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONE	FOURCOMPANY CO., LTD.	f8203d54-cd3d-314d-e053-6394a90ac10d	2026-06-04	Warnings	Exact identifier application number: M020
Play Everyday Sunscreen SPF 50 with Sunflower Extract	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	0428eebc-4ffb-4981-b738-2c9ecf2a6a2e	2026-06-04	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
61354-083-01	61354008301	1 TUBE in 1 CARTON (61354-083-01) > 100 mg in 1 TUBE	1 tube	2022-08-30	0000-00-00	No	No	Current