Cream

Product NDC: 61354-086
11-digit product format: 613540086
Labeler code: 61354
Product ID: 61354-086_e776f37b-869c-5861-e053-2995a90a19f5
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide, Titanium Dioxide
Dosage form: CREAM
Route: TOPICAL
Labeler: Oxygen Development LLC
Application: M020
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2022-08-30
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	61354-086		I	Inactivated by FDA		2026-10-27
excluded package	package	61354-086	61354-086-01	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	61354-086-01	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	61354-086-01	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	61354-086-01	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	61354-086-01	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	61354-086-01	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	61354-086-01	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	61354-086-01	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	61354-086-01	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	61354-086-01	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
61354-086-01	2025-01-30	C162847	48780-1	2cef2736-a604-d83d-e063-dadaa90ab31f	TARTE high-performance naturals BB tinted treatment primer Broad Spectrum SPF 30 Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61354-086-01	Cream	1 in 1 CARTON	CREAM	1		1
61354-086-01	Cream	100 mg in 1 TUBE	CREAM	100		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61354-086	CREAM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [OXYGEN DEVELOPMENT LLC]	1	Legacy NDC, 2 package rows	20220831_e776f37b-869b-5861-e053-2995a90a19f5.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 193 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olay Total Effects Moisturizer Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	The Procter & Gamble Manufacturing Company	8de52cb2-b4d2-1e0d-e053-2995a90a5aca	2025-08-19	Warnings	Exact identifier application number: M020
Sun Bum 30 Mineral Sunscreen Lip Balm	ZINC OXIDE	Sun Bum, LLC	3cbfba65-5702-50b5-e063-6394a90a409d	2025-08-19	Warnings	Exact identifier application number: M020
Sun Bum Signature High Performance Mineral Sunscreen Face Stick Tinted 50	ZINC OXIDE	Sun Bum, LLC	324e8ddb-89d2-08ca-e063-6294a90ab6c1	2025-08-19	Warnings	Exact identifier application number: M020
Sun Bum 70 Premium Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3b02811d-dc66-fc6f-e063-6294a90aefc8	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum Kids 50 Clear Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3b058b74-27d0-8f8a-e063-6294a90aa02c	2025-08-18	Warnings	Exact identifier application number: M020
PLAY Mineral Stick SPF 50 with Olive Fruit Extract	ZINC OXIDE	Supergoop LLC	3ca7e1ed-7cc7-76b0-e063-6394a90ade93	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum Mineral 30 Sunscreen 6 OZ	ZINC OXIDE	Sun Bum, LLC	3b91a7e3-ce52-6aa0-e063-6394a90a15e7	2025-08-18	Warnings	Exact identifier application number: M020
CoTZ Kids	ZINC OXIDE	Fallien Cosmeceuticals, LTD.	3ca8742f-67cb-a25c-e063-6394a90a4638	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum 30 Premium Moisturizing Sunscreen 8 OZ	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3b154009-9c6f-eadf-e063-6394a90ae424	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum Kids 50 Clear Sunscreen 6 OZ	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3b162348-0222-490e-e063-6394a90ad494	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum 50 Premium Moisturizing Sunscreen 1.75 OZ	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3b169860-66bc-dd02-e063-6294a90a7974	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum 30 Mineral Sunscreen Face 1.7 OZ	TITANIUM DIOXIDE, ZINC OXIDE	Sun Bum, LLC	3b1729c5-d8ca-94c7-e063-6394a90a67a5	2025-08-18	Warnings	Exact identifier application number: M020
CoTZ Kids	ZINC OXIDE	Fallien Cosmeceuticals, LTD.	3ca914e2-cd53-42bf-e063-6294a90a7082	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum Daily Mineral Sunscreen Moisturizer Broad Spectrum SPF 30	ZINC OXIDE	Sun Bum, LLC	3b1a0596-b852-16be-e063-6394a90a3498	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum Signature Clear High Performance Sunscreen Broad Spectrum SPF 50 1.5 OZ	OCTISALATE, OCTOCRYLENE, ZINC OXIDE	Sun Bum, LLC	3b29dbfc-0b92-eb0f-e063-6294a90a16e1	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum 30 Mineral Sunscreen 32 OZ	ZINC OXIDE	Sun Bum, LLC	3b2cb7cf-7e2c-0fd2-e063-6294a90a3b17	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum Sunscreen Oil 50 5 OZ	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3b2b4ba0-3f89-0a04-e063-6294a90ac1c0	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum Signature Sunscreen Premium Zinc Lip Balm Broad Spectrum SPF 30	ZINC OXIDE	Sun Bum, LLC	3ca9e9d3-1c73-7bd6-e063-6394a90ad204	2025-08-18	Warnings	Exact identifier application number: M020
Ocean Potion Suncare Mineral 50 Essential Scent of Sunshine Zinc Oxide Continuous Sunscreen	ZINC OXIDE	GNL BRANDS INTERNATIONAL, LLC	3caaea85-0dfe-6f69-e063-6294a90a7d4a	2025-08-18	Warnings	Exact identifier application number: M020
PLAY Lip Shield SPF 30 - Mint	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop LLC	3cab1a7d-6226-9eba-e063-6294a90a8c4d	2025-08-18	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
61354-086-01	61354008601	1 TUBE in 1 CARTON (61354-086-01) > 100 mg in 1 TUBE	1 tube	2022-08-30	0000-00-00	No	No	Current