Cream

Product NDC: 61354-081
11-digit product format: 613540081
Labeler code: 61354
Product ID: 61354-081_e715df51-25f7-298a-e053-2a95a90a0464
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide, Titanium Dioxide
Dosage form: LOTION
Route: TOPICAL
Labeler: Oxygen Development LLC
Application: M020
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2022-08-25
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	61354-081		I	Inactivated by FDA		2026-10-27
excluded package	package	61354-081	61354-081-01	I	Inactivated by FDA		2026-10-27

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	61354-081-01	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	61354-081-01	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	61354-081-01	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	61354-081-01	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	61354-081-01	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	61354-081-01	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	61354-081-01	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	61354-081-01	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	61354-081-01	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
61354-081-01	2025-01-30	C162847	48780-1	2cef2736-6321-d83d-e063-dadaa90ab31f	SKIN TREAT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61354-081-01	Cream	100 mg in 1 TUBE	LOTION	100		1
61354-081-01	Cream	1 in 1 CARTON	LOTION	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61354-081	CREAM (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [OXYGEN DEVELOPMENT LLC]	1	Legacy NDC, 2 package rows	20220827_e715df51-25f6-298a-e053-2a95a90a0464.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 229 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quick Screen Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	The Quick Flick PTY LTD	3788666e-7efa-43da-95f5-6218b7fcb6ea	2025-02-12	Warnings	Exact identifier application number: M020
Dolce AND Gabbana Get Your Healthy Glowy Skin	ZINC OXIDE	Socoplan	91bf1cca-8d18-4c59-864d-4fd0619c6713	2025-02-12	Warnings	Exact identifier application number: M020
Cell Fusion C Aquatica UV Defense Sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CMS LAB Inc.	2dfd1f99-5896-1e0f-e063-6394a90aa71d	2025-02-12	Warnings	Exact identifier application number: M020
Biore Aqua Rich UV	OCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATE	KAO USA	f9024581-dbab-b7cb-e053-6294a90a8b9a	2025-02-12	Warnings	Exact identifier application number: M020
Dr Loretta Universal Glow Daily Defense SPF 40	ZINC OXIDE	Dr. Loretta, LLC	ebdaf6c1-1572-4840-851b-6d780471fcb2	2025-02-11	Warnings	Exact identifier application number: M020
Sky and Sol Body Sunscreen SPF50	SKY AND SOL BODY SUNSCREEN SPF50	Guangzhou Fantesy Biotechnology Co.,Ltd	2de9173b-fa02-8017-e063-6394a90ae0aa	2025-02-11	Warnings	Exact identifier application number: M020
Beeswax SPF 15 Broad Spectrum Lip Balm	BEESWAX SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	2dcc2f9b-4a8c-b281-e063-6294a90ad9d6	2025-02-10	Warnings	Exact identifier application number: M020
Broad Spectrum SPF 30 Tropical Sunscreen	BROAD SPECTRUM SPF 30 TROPICAL SUNSCREEN	Raining Rose, Inc	2dcca380-c0e4-4e04-e063-6394a90ac31e	2025-02-10	Warnings	Exact identifier application number: M020
Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Sunscreen Deep	ENSULIZOLE, OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE	Amway Corp	88021a24-d3b5-48f8-8d26-affbfcfd098f	2025-02-10	Warnings	Exact identifier application number: M020
Sun Defense Minerals (Sheer)	ZINC OXIDE, TITANIUM DIOXIDE	Eminence Organic Skin Care	2dd20800-2cf9-02d4-e063-6294a90a0f00	2025-02-10	Warnings	Exact identifier application number: M020
Bondi Sands Fragrance Free Face SPF 50 Sunscreen Mist	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	BONDI SANDS (USA) INC.	2dd5ea23-eee6-5d14-e063-6294a90a0fd3	2025-02-10	Warnings	Exact identifier application number: M020
Centella Calming SUNSCREEN	CENTELLA CALMING SUNSCREEN	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	2dc0ee9b-d58b-fe40-e063-6394a90af439	2025-02-09	Warnings	Exact identifier application number: M020
SOME BY MI V10 HYAL LIP SUN PROTECTOR ROSY	AVOBENZONE, HOMOSALATE, OCTISALATE	PERENNEBELL Co., Ltd	2dc25afb-a171-f1f2-e063-6294a90ae333	2025-02-09	Warnings	Exact identifier application number: M020
SOME BY MI V10 HYAL LIP SUN PROTECTOR BERRY	AVOBENZONE, HOMOSALATE, OCTISALATE	PERENNEBELL Co., Ltd	2dc285ad-08cd-14e6-e063-6294a90a24fc	2025-02-09	Warnings	Exact identifier application number: M020
PROBIOTIC RICE Sunscreen	PROBIOTIC RICE SUNSCREEN	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	2d9d6440-39b3-312a-e063-6394a90aa072	2025-02-08	Warnings	Exact identifier application number: M020
NIA 24 SPF 30	HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE	Niadyne Inc	e5c9d56f-48b4-4f0e-add6-f73268755b16	2025-02-07	Warnings	Exact identifier application number: M020
Pacific Mango Sunscreen SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	SAN DIEGO NATURAL SOAP COMPANY	d09e3096-0678-4433-a555-61f18a45873b	2025-02-06	Warnings	Exact identifier application number: M020
DR.JART CICAPAIR TIGER GRASS COLOR CORRECTING TREATMENT	ZINC OXIDE, TITANIUM DIOXIDE	Have & Be Co., Ltd.	01cfe6a6-c2e4-8fb8-e063-6294a90adc78	2025-02-06	Warnings	Exact identifier application number: M020
Dr.Jart Premium Beauty Balm Medium-Tan	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Have & Be Co., Ltd.	02a8bab8-ca5d-6b65-e063-6294a90abb07	2025-02-06	Warnings	Exact identifier application number: M020
Dr.Jart Premium Beauty Balm Fair-Light	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Have & Be Co., Ltd.	02a82029-bdb1-cbe0-e063-6294a90a08f3	2025-02-06	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
61354-081-01	61354008101	1 TUBE in 1 CARTON (61354-081-01) > 100 mg in 1 TUBE	1 tube	2022-08-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SKIN TREAT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN	Oxygen Development LLC	2022-08-25	HUMAN OTC DRUG LABEL	1