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		2026-10-27

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 · 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 191 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sun Bum Sunscreen Lip Balm Broad Spectrum SPF 30 - Coconut	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3d37ec29-8d15-c716-e063-6394a90ae709	2025-08-25	Warnings	Exact identifier application number: M020
RMS REFRESH EYE BRIGHTENER SPF 30 BROAD SPECTRUM SUNSCREEN ADORE	ZINC OXIDE	Rms organics LLC	3d386cc9-e097-dacf-e063-6294a90a8fe2	2025-08-25	Warnings	Exact identifier application number: M020
Baby Bum Mineral 50 Mineral Sunscreen Face Stick	ZINC OXIDE	Sun Bum, LLC	3d3a0d5c-a366-22fc-e063-6394a90a308b	2025-08-25	Warnings	Exact identifier application number: M020
BOB Kids Sun Balm SPF 40	ZINC OXIDE 23%	SPF Ventures, LLC	efa5c501-273c-5e97-e053-2995a90a865b	2025-08-24	Warnings	Exact identifier application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 6	ENSULIZOLE ,HOMOSALATE ,OCTINOXATE,TITANIUM DIOXIDE	Longway Technology(Guangzhou) Co., Ltd.	3d0359b6-088f-aa54-e063-6394a90a422f	2025-08-23	Warnings	Exact identifier application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF50	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	e4a2e6e4-5c35-4178-b341-65644233b7b8	2025-08-22	Warnings	Exact identifier application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	57f91218-2477-4495-98e8-c512d823e158	2025-08-22	Warnings	Exact identifier application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	c358745d-b9c0-4a9e-9a83-caffa04ea2e5	2025-08-22	Warnings	Exact identifier application number: M020
Neutrogena Age Shield Face Oil Free Sunscreen Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	050c2997-3ec0-4515-8a67-709b07a5010f	2025-08-22	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	3cf3e27d-ab16-4f12-e063-6394a90a70e2	2025-08-22	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	3cf42e31-4e11-9b6d-e063-6294a90aa741	2025-08-22	Warnings	Exact identifier application number: M020
Sun Bum Kids 50 Clear Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3c1f619e-dd4e-ab62-e063-6294a90a10d4	2025-08-22	Warnings	Exact identifier application number: M020
Sun Bum Premium Moisturizing Sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3cf8c55b-5203-3a96-e063-6294a90a4e9e	2025-08-22	Warnings	Exact identifier application number: M020
Baby Bum Mineral 50 Sunscreen	ZINC OXIDE	Sun Bum LLC	369f449f-fb9d-5529-e063-6394a90ac3b2	2025-08-22	Warnings	Exact identifier application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 4	ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDE	Longway Technology(Guangzhou) Co., Ltd.	3cdc1ae9-2924-5057-e063-6294a90ad2f3	2025-08-21	Warnings	Exact identifier application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 3	ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDE	Longway Technology(Guangzhou) Co., Ltd.	3b21f1d8-534d-f4ea-e063-6294a90ad2eb	2025-08-21	Warnings	Exact identifier application number: M020
LBEL CONCENTRE GLOBAL ANTI AGING SERUM FOUNDATION SPF 15 ALMENDRA 230N	OCTINOXATE, ZINC OXIDE	BEL STAR S.A.	2cb3cd01-8871-59a0-e063-6394a90ac0f7	2025-08-21	Warnings	Exact identifier application number: M020
Neutrogena Triple Age Repair Moisturizer with Sunscreen Broad Spectrum SPF 25	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	a6011835-cd2f-476f-9ec1-721f896483c5	2025-08-21	Warnings	Exact identifier application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	35fc2571-370c-42aa-986c-b1fa58658d86	2025-08-21	Warnings	Exact identifier application number: M020
Sun Bum 50 Sunscreen Face Stick	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3ce436e8-bc22-b9d7-e063-6394a90a57c4	2025-08-21	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