Cream

Product NDC: 61354-082
Requested package NDC: 61354-082-01
11-digit product format: 613540082
Labeler code: 61354
Product ID: 61354-082_e724e10c-4f05-b03d-e053-2a95a90a754c
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: 2022-08-26
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	61354-082	61354-082-01	I	Inactivated by FDA		2026-11-13

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 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	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
61354-082-01	2025-01-30	C162847	48780-1	2cef2736-b0b7-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
61354-082-01	Cream	1 in 1 CARTON	LOTION	1		1
61354-082-01	Cream	100 mg in 1 TUBE	LOTION	100		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61354-082	CREAM (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [OXYGEN DEVELOPMENT LLC]	1	Legacy NDC, 2 package rows	20220827_e724e098-f5c9-262a-e053-2995a90a2a02.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 224 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
COOLA Classic Liplux Lip Balm SPF 30 Tinted	AVOBENZONE, OCTISALATE, OCTOCRYLENE	COOLA, LLC	eec6e7c8-17fe-f34b-e053-2995a90a78a0	2025-02-20	Warnings	Exact identifier application number: M020
Drops	AVOBENZONE OCTISALATE OCTOCRYLENE	Vacation Inc.	1319d6ea-a580-79c5-e063-6394a90a4dca	2025-02-20	Warnings	Exact identifier application number: M020
Vacation SPF 50 Super Spritz Face Mist	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Vacation Inc.	f67fbe98-93ce-2882-e053-2a95a90ab713	2025-02-20	Warnings	Exact identifier application number: M020
REPAIRWEAR UPLIFTING FIRMING BROAD SPECTUM SPF 15 - NORMAL COMBO TO COMBINATION oily	OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE	CLINIQUE LABORATORIES LLC	10edc0c1-9359-4c7a-a56e-bad06fea0056	2025-02-20	Warnings	Exact identifier application number: M020
Mineral SPF 30 Brush-On Sun Defense	ZINC OXIDE	Mineral Fusion	29733dba-8824-461e-be44-335d6fe50d60	2025-02-19	Warnings	Exact identifier application number: M020
Neutrogena Healthy Skin Invisibly Radiant UV Primer SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Kenvue Brands LLC	20cd4d96-2046-3a50-e063-6394a90a1219	2025-02-18	Warnings	Exact identifier application number: M020
COOLA Classic Body SPF 30 Pina Colada	AVOBENZONE, OCTISALATE, OCTOCRYLENE	COOLA, LLC	edc59de7-c817-1a59-e053-2995a90a3408	2025-02-17	Warnings	Exact identifier application number: M020
Liplux SPF 30 Lip Balm	CLASSIC	COOLA LLC	b47b5f3a-43f3-ae7a-e053-2995a90ae16d	2025-02-17	Warnings	Exact identifier application number: M020
COOLA Classic Body SPF 50 Fragrance Free	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	COOLA, LLC	ed207afe-0b10-74c7-e053-2a95a90a9b87	2025-02-17	Warnings	Exact identifier application number: M020
Avon Skin-So-Soft Bug Guard plus SPF 30 Sunscreen Gentle Breeze Insect Repellent Sunscreen	OCTINOXATE, OXYBENZONE, OCTISALATE	The Avon Company	2e5d6c93-f091-5388-e063-6394a90ad560	2025-02-17	Warnings	Exact identifier application number: M020
KEYS SOULCARE DAILY MOISTURIZER BROAD SPECTRUM SPF30 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc	31a98dc7-4b99-d845-e063-6394a90a2670	2025-02-17	Warnings	Exact identifier application number: M020
Ultra sheer mineral sunscreen PRO SPF30	ZINC OXIDE	Eden Brands Inc.	2ce06566-2eb0-9a00-e063-6394a90a9ba9	2025-02-14	Warnings	Exact identifier application number: M020
Cell Fusion C Laser UV Defense Sunscreen Broad Spectrum SPF 50	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	CMS LAB Inc.	2dff0386-e151-089a-e063-6394a90a0f53	2025-02-14	Warnings	Exact identifier application number: M020
Cell Fusion C Airy Stick Sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CMS LAB Inc.	2dffc699-3b56-2c70-e063-6294a90ae249	2025-02-14	Warnings	Exact identifier application number: M020
Sun Defense Minerals (Sheer)	ZINC OXIDE, TITANIUM DIOXIDE	Eminence Organic Skin Care	2e2082aa-5ae3-2c04-e063-6294a90a140b	2025-02-14	Warnings	Exact identifier application number: M020
Coola SPF 30 Mineral Sunscreen Fragrance Free	ZINC OXIDE	COOLA, LLC	edc6048e-0ea0-41c5-e053-2a95a90a96d9	2025-02-14	Warnings	Exact identifier application number: M020
COOLA Classic Body SPF 50 Guava Mango	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	COOLA, LLC	ed13afaa-35ec-8326-e053-2995a90adaf0	2025-02-14	Warnings	Exact identifier application number: M020
Sun Defense Minerals (Light)	ZINC OXIDE, TITANIUM DIOXIDE	Eminence Organic Skin Care	2e21f5bb-e7df-b43b-e063-6394a90a0f82	2025-02-14	Warnings	Exact identifier application number: M020
Sun Defense Minerals (Fair)	ZINC OXIDE, TITANIUM DIOXIDE	Eminence Organic Skin Care	2e2102c6-02ea-3a8f-e063-6394a90abf5e	2025-02-14	Warnings	Exact identifier application number: M020
Sunscreen Broad Spectrum SPF 50 Vi Aesthetics	ZINC OXIDE, OCTINOXATE	Vi Medical Products, INC	73620765-c7c0-4bd7-82a9-00022773c928	2025-02-14	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
61354-082-01	61354008201	1 TUBE in 1 CARTON (61354-082-01) > 100 mg in 1 TUBE	1 tube	2022-08-26	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	2022-08-27	HUMAN OTC DRUG LABEL	1