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 217 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
No7 Lift and Luminate Triple Action Fragrance Free Day Cream SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	BCM Cosmetique SAS	32b5a19e-86d4-5ee1-e063-6394a90a12e2	2025-04-11	Warnings	Exact identifier application number: M020
LERINN ZINCPURE SUNMILK SPF 50	ZINC OXIDE	Serrina Lin Skincare Inc	32717b49-729c-a229-e063-6394a90a18fb	2025-04-10	Warnings	Exact identifier application number: M020
Smoothing Mineral Sunscreen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	DANIEL BEHROOZAN MD A MEDICAL CORPORATION	327246c2-9d7a-2d34-e063-6294a90a5fb7	2025-04-10		Exact identifier application number: M020
Clarity Rx Physical Skin Defense SPF 50	ZINC OXIDE AND TITANIUM DIOXIDE	Topiderm, Inc.	b5111012-97b9-4908-95a0-d09595f9c4d9	2025-04-10	Warnings	Exact identifier application number: M020
Tinted Mineral Sunscreen SPF 50	ZINC OXIDE AND TITANIUM DIOXIDE	Topiderm, Inc.	13e5085f-df2b-46b2-b063-e58ce4379905	2025-04-09	Warnings	Exact identifier application number: M020
Sunstation Sport Sunscreen SPF 30	OCTOCRYLENE, ZINC OXIDE, OCTISALATE	Sunstation USA LLC	6007c125-f28a-45e5-b8f1-490ee04b7811	2025-04-09	Warnings	Exact identifier application number: M020
Pacifica Sun Dreams Illuminating SPF Foam	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Pacifica Beauty, LLC	2e0cb105-75c3-8032-e063-6394a90ab502	2025-04-09	Warnings	Exact identifier application number: M020
belif Aqua bomb - glow sunstick SPF50	HOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANE	LG H&H CO., LTD.	284cadf1-deb9-4f3d-e063-6394a90ab122	2025-04-09	Warnings	Exact identifier application number: M020
ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (ROSA ROMANTICA FEMME) - PINK	OCTINOXATE AND OXYBENZONE	Ventura Corporation LTD	aa79b1a4-6b33-47c9-b55e-b813d9b22265	2025-04-09	Warnings	Exact identifier application number: M020
Brush On Block SPF 30 Mineral Powder Touch of Tan Zinc Only	ZINC OXIDE	SPF Ventures, LLC	3240cbe5-bfc8-17f7-e063-6394a90a1b98	2025-04-08	Warnings	Exact identifier application number: M020
ISA KNOX UV SUN PRO 365 Sheer Mineral Face	ZINC OXIDE	LG HOUSEHOLD & HEALTH CARE LTD.	2eeac795-b74e-b3a3-e063-6294a90abf52	2025-04-08	Warnings	Exact identifier application number: M020
The Face Shop Hydro Sun Barrier 2-in-1 SPF and Moisturizer	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	LG HOUSEHOLD & HEALTH CARE LTD.	2ee9f271-b508-2304-e063-6294a90a3752	2025-04-08	Warnings	Exact identifier application number: M020
CLARINS Multi-Active Jour Niacinamide and Sea Holly Extract Sunscreen SPF 15	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Laboratoires Clarins	a43d0d4f-94de-4c4b-a17a-63a819d5d293	2025-04-07	Warnings	Exact identifier application number: M020
Gangnam Glow Sunscreen 50	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	LG HOUSEHOLD & HEALTH CARE LTD.	30cc2e35-f752-8285-e063-6294a90afbf5	2025-04-07	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	26f8dc88-2096-4fa1-81ae-ea92fe1f353d	2025-04-07	Warnings	Exact identifier application number: M020
Vacation Instant Browning	AVOBENZONE OCTISALATE OCTOCRYLENE	Vacation Inc.	13028f61-3f62-22cc-e063-6394a90a6bf1	2025-04-04	Warnings	Exact identifier application number: M020
LBri Pure n Natural SPF 30	ZINC OXIDE	L'BRI HEALTH & BEAUTY	8350791d-5cf2-4358-9f85-9384d35be9f4	2025-04-03	Warnings	Exact identifier application number: M020
SHEER MINERAL SUNSCREEN	ZINC OXIDE	Plant Devas Inc. dba evanhealy	f620ef44-f30c-4cc9-bc82-28dc4a47a8da	2025-04-02	Warnings	Exact identifier application number: M020
CLEAR GLOW BROAD SPECTRUM SUNCREEN SPF 50	AVOBENZONE, HOMOSALATE OCTISALATE, OCTOCRYLENE	NAKED SUNDAYS PTY LTD	0116cffa-3415-746b-e063-6394a90ab3b3	2025-04-01	Warnings	Exact identifier application number: M020
HYDRATING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF50 SPF 50	AVOBENZONE, HOMOSALATE OCTISALATE,	NAKED SUNDAYS PTY LTD	04293280-e74a-f293-e063-6394a90a06f6	2025-04-01	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