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		2026-10-28
excluded package	package	61354-081	61354-081-01	I	Inactivated by FDA		2026-10-28

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 247 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Almay Healthy Biome Makeup	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Almay	ab20969a-8640-307d-e053-2a95a90a004d	2024-12-30	Warnings	Exact identifier application number: M020
EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUS	OCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLE	Exelencia importers Corp.	2a845e4c-86e7-1799-e063-6294a90a9b2b	2024-12-30	Warnings	Exact identifier application number: M020
American Crew All In One Face Balm Broad Spectrum SPF 15	OCTISALATE,HOMOSALATE,AVOBENZONE,OCTOCRYLENE	Revlon Consumer Products Corp	012be422-1b4c-443c-9484-02efc744296d	2024-12-30	Warnings	Exact identifier application number: M020
Advanced Ceramide Lift and Firm Day Cream Broad Spectrum Sunscreen SPF 15	OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATE	REVLON	2a857553-5ad0-a0e2-e063-6294a90af435	2024-12-30	Warnings	Exact identifier application number: M020
SkinCeuticals Sheer Physical UV Defense Broad Spectrum SPF 50 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	2035ab03-80b4-49f4-b379-eb8bc42c9cee	2024-12-30	Warnings	Exact identifier application number: M020
PRISMA PROTECT SPF30	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Dermalogica, LLC.	713bad2e-bf32-4cd5-9630-b8d88d437686	2024-12-30	Warnings	Exact identifier application number: M020
Protection 50 Sport	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Dermalogica, LLC.	e9ace96a-7717-4f5a-8e1b-1f56f7498599	2024-12-30	Warnings	Exact identifier application number: M020
SkinCeuticals Physical Matte UV Defense Broad Spectrum SPF 50 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	b137b3d0-212b-440a-b158-62ace4b4eff3	2024-12-30	Warnings	Exact identifier application number: M020
SkinCeuticals Physical UV Defense Broad Spectrum SPF 30 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	3a6db7d3-6c59-4633-a97e-1c03127246d3	2024-12-30	Warnings	Exact identifier application number: M020
Dermablend Professional Leg and Body Makeup Broad Spectrum SPF 25 Sunscreen	OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	df62e1c2-ce72-4ded-8985-156dce9ff41d	2024-12-28	Warnings	Exact identifier application number: M020
LOreal Paris Revitalift Derm Intensives Invisible UV Fluid Broad Spectrum SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	L'Oreal USA Products Inc	02dddfc5-61e6-433b-8d6d-a17bf3fc8ed6	2024-12-28	Warnings	Exact identifier application number: M020
Vichy Laboratoires Aqualia Thermal UV Defense Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	Cosmetique Active Production	229eef79-39ae-4395-8100-64d1ece960d2	2024-12-28	Warnings	Exact identifier application number: M020
COOLA Mineral Sun Silk Creme Sunscreen SPF 30	ZINC OXIDE	COOLA LLC	bb9dd9a9-ec01-4e94-9172-3a72e68a417a	2024-12-27	Warnings	Exact identifier application number: M020
Bare Republic Mineral SPF 50	ZINC OXIDE	COOLA LLC	6a0db9da-ee45-4ab7-80de-4bf189efe75f	2024-12-27	Warnings	Exact identifier application number: M020
COOLA CLASSIC BODY SUNSCREEN Guava Mango Broad Spectrum SPF 50	AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE	COOLA LLC	9a397a2c-4734-4dae-93dd-15c68e6c297d	2024-12-27	Warnings	Exact identifier application number: M020
Refreshing Water Hydration Stick SPF 50	AVOBENZONE OCTISALATE HOMOSALATE OCTOCRYLENE	COOLA LLC	6da037f8-bedb-467a-b534-e44752120f2c	2024-12-27	Warnings	Exact identifier application number: M020
Nu Skin ageLOC Radiant Day Broad Spectrum SPF 22	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	NSE Products, Inc.	649a9c28-bfd4-404c-90d5-5d0ea8c7b645	2024-12-27	Warnings	Exact identifier application number: M020
Kiehls Since 1851 Activated Sun Protector For Face and Body Broad Spectrum SPF 50 Sunscreen	TITANIUM DIOXIDE	L'Oreal USA Products Inc	87496037-36ca-4c5f-973f-46626cf4096e	2024-12-27	Warnings	Exact identifier application number: M020
PORESCREEN SPF40	ZINC OXIDE	Dermalogica, LLC.	37a7362a-b251-4d3a-a957-65d8f338fa12	2024-12-27	Warnings	Exact identifier application number: M020
COOLA Classic Face Sunscreen Fragrance-Free SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	COOLA LLC	12ff4689-f7e2-49db-8848-608c61b41ef0	2024-12-27	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