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 192 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 FUCHSIA CREAMY	OCTINOXATE, ZINC OXIDE	BEL STAR S A	ea39a1c0-6b12-77ba-e053-2995a90a7314	2025-08-21	Warnings	Exact identifier application number: M020
Neutrogena Clear Face Breakout Free Oil Free Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	cd211d06-b91e-44b1-99fe-fa0794f10221	2025-08-21	Warnings	Exact identifier application number: M020
Sun Bum Sunscreen Lip Balm Broad Spectrum SPF 30 Kiwi	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3cd51497-693e-bf79-e063-6394a90a5e48	2025-08-21	Warnings	Exact identifier application number: M020
LBEL SOLUTIONS PRO-NUDE SKIN ULTRA-LIGHT SERUM FOUNDATION WITH NIACINAMIDE SPF 20 CHAMPAGNE 170N	OCTINOXATE, ZINC OXIDE	BEL STAR S.A.	2f769ed5-0176-8c80-e063-6394a90a92c6	2025-08-21	Warnings	Exact identifier application number: M020
Sun Bum 30 Premium Moisturizing Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	21caf385-f11b-146a-e063-6294a90aa851	2025-08-21	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	3ce6d119-5e3e-dfa4-e063-6394a90a474b	2025-08-21	Warnings	Exact identifier application number: M020
Sun Bum 50 Premium Moisturizing Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	21cb8652-c6d0-0a77-e063-6294a90a6e1e	2025-08-21	Warnings	Exact identifier application number: M020
Sun Bum Signature High Performance Mineral Sunscreen Face Stick 30	ZINC OXIDE	Sun Bum, LLC	3ce81478-196e-d87b-e063-6294a90afd58	2025-08-21	Warnings	Exact identifier application number: M020
Premium Moisturizing Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	33164cea-e31e-9fcc-e063-6294a90a307e	2025-08-21	Warnings	Exact identifier application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 5	ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDE	Longway Technology(Guangzhou) Co., Ltd.	3ceb3368-439c-9f6c-e063-6294a90a98ba	2025-08-21	Warnings	Exact identifier application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 2	ENSULIZOLE ,HOMOSALATE ,OCTINOXATE,TITANIUM DIOXIDE	Longway Technology(Guangzhou) Co., Ltd.	3cc8b151-c07d-7473-e063-6294a90a1cc7	2025-08-20	Warnings	Exact identifier application number: M020
Olay Complete Hydrating with Sunscreen Broad Spectrum SPF 15	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	3ccd2703-c410-74b7-e063-6294a90a7f88	2025-08-20	Warnings	Exact identifier application number: M020
SEYE	ZINC OXIDE AND TITANIUM DIOXIDE CREAM	Guangzhou Seye Biomedical Technology Co., Ltd.	3cce91b1-311b-4c95-e063-6294a90a2d7a	2025-08-20	Warnings	Exact identifier application number: M020
Sun Bum Day Tripper - SPF 30 Moisturizing Sunscreen 3 OZ	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3ccfb90a-5976-4b38-e063-6294a90a123a	2025-08-20	Warnings	Exact identifier application number: M020
Sun Bum Day Tripper - SPF 30 Sunscreen Lip Balm (Coconut) 0.15 OZ	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3cd3ce69-becc-41b7-e063-6394a90a2782	2025-08-20	Warnings	Exact identifier application number: M020
Lip Therapy Soothe and Protect Lip Treatment Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Obagi Cosmeceuticals LLC	4838679b-f510-440b-8670-a10c05ebed9b	2025-08-19	Warnings	Exact identifier application number: M020
Sun Bum Signature High Performance Mineral Sunscreen Broad Spectrum SPF 50 New	ZINC OXIDE	Sun Bum, LLC	3b8e1d73-b023-cfbd-e063-6294a90ae29d	2025-08-19	Warnings	Exact identifier application number: M020
Olay Total Effects Moisturizer with Sunscreen Broad Spectrum SPF 15 Fragrance-Free	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	8de31db2-46cf-7178-e053-2995a90a5024	2025-08-19	Warnings	Exact identifier application number: M020
Lip Balm - Variety Pack (Target) - Banana (4)	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3cbcae23-9b38-edaa-e063-6294a90a2e8f	2025-08-19	Warnings	Exact identifier application number: M020
Sun Bum Signature High Performance Mineral Sunscreen Lip Balm 30	ZINC OXIDE	Sun Bum, LLC	3cbeb4ce-6d7c-387c-e063-6394a90af790	2025-08-19	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