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		2026-10-05
excluded package	package	61354-086	61354-086-01	I	Inactivated by FDA		2026-10-05

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 2 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Intense Therapy Lip Balm Asian Pear	SUNSCREEN SKIN PROTECTANT LIP BALM	Jack Black, LLC	acace707-6671-4818-86f2-d9813792157a	2026-09-08	Warnings	Exact identifier application number: M020
Intense Therapy Lip Balm Basil Lemon	SUNSCREEN SKIN PROTECTANT LIP BALM	Jack Black, LLC	277cb44d-608a-4ffc-a2a5-ac57d33d214c	2026-09-08	Warnings	Exact identifier application number: M020
Intense Therapy Lip Balm Black Cherry	SUNSCREEN SKIN PROTECTANT LIP BALM	Jack Black, LLC	8f413bd6-258c-4c3c-89d1-369938c85720	2026-09-08	Warnings	Exact identifier application number: M020
Intense Therapy Lip Balm Cucumber Lime	SUNSCREEN SKIN PROTECTANT LIP BALM	Jack Black, LLC	5f15bee9-9bf4-4f27-a6b5-4205deb625f6	2026-09-08	Warnings	Exact identifier application number: M020
Intense Therapy Lip Balm Winter Melon	SUNSCREEN SKIN PROTECTANT LIP BALM	Jack Black, LLC	e7792b4e-a6d2-487e-ba28-27b68e6d7e27	2026-09-08	Warnings	Exact identifier application number: M020
Jack Black Intense Therapy Lip Balm Vanilla Bourbon	AVOBENZONE, OCTINOXATE LIP BALM SUNSCREEN	Jack Black, LLC	517040d1-e6ed-40ca-a46f-2f75403dbc3c	2026-09-08	Warnings	Exact identifier application number: M020
Intense Therapy Lip Balm Mango and Mandarin	SUNSCREEN SKIN PROTECTANT LIP BALM	Jack Black, LLC	8c55d1cd-cdd6-468b-8a17-b940c6210116	2026-09-08	Warnings	Exact identifier application number: M020
Jack Black Intensive Therapy Lip Balm Mango Chili Lime	AVOBENZONE, OCTINOXATE LIP BALM SUNSCREEN	Jack Black, LLC	51349d57-b14d-4798-8d68-03fbe3713d1e	2026-09-08	Warnings	Exact identifier application number: M020
Jack Black Sun Guard Sunscreen SPF45	SUNSCREEN	Jack Black, LLC	3cc86bb2-05ce-47eb-8c71-f4f116ca5840	2026-09-08	Warnings	Exact identifier application number: M020
Jack Black Intense Thearpy Lip Balm SPF25, Lemon and Shea Butter	LIP BALM SUNSCREEN	Jack Black, LLC	518cb17a-fdaa-4a60-93fc-708305366eb8	2026-09-08	Warnings	Exact identifier application number: M020
Jack Black Lavender Lip Balm 0.25oz	LIP BALM SUNSCREEN	Jack Black, L.L.C.	e8c6a6d9-1093-41f1-87d5-faf8583d4319	2026-09-08	Warnings	Exact identifier application number: M020
SPF15 lip balm 01	OCTOCRYLENE, OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	f8695305-b89d-c21c-e053-6394a90a0e84	2026-09-08	Warnings	Exact identifier application number: M020
Sunscreen stick	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	e9f963ee-a98c-efc1-e053-2a95a90aaf53	2026-09-08	Warnings	Exact identifier application number: M020
SPF30 Sunscreen 01	AVOBENZONE ,HOMOSALATE,OCTOCRYLENE, OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	5b04751d-32e9-a7e2-e063-6294a90aefbd	2026-09-08	Warnings	Exact identifier application number: M020
Juyasuyon Invisible Sunscreen	HOMOSALATE,OCTOCRYLENE,OCTISALATE,BEMOTRIZINOL,AVOBENZONE	Guangdong Aimu Biological Technology Co., Ltd	5ab335b5-bb9e-4642-e063-6294a90a3986	2026-09-05	Warnings	Exact identifier application number: M020
No7 Future Renew Defense Shield SPF 50	AVOBENZONE, OCTINOXATE, OCTISALATE	BCMC	41cc2c52-c6a4-611c-e063-6294a90aae01	2026-09-03	Warnings	Exact identifier application number: M020
WALMART EQUATE SUNSCREEN SPF 50 SPORT BROAD SPECTRUM	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALMART, INC.	58b5d0ce-9157-9dee-e063-6394a90ab543	2026-09-02	Warnings	Exact identifier application number: M020
Chantecaille Ultra Sun Protection Sunscreen SPF 45	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Chantecaille Beaute Inc	6186ea56-7d56-43f5-985d-a012f1296afa	2026-09-02	Warnings	Exact identifier application number: M020
ULTRA VIOLETTE Fave Screen Broad Spectrum SPF 50	AVOBENZONE, BEMOTRIZINOL, OCTISALATE	Grace and Fire USA	5739c5b9-00d8-75a8-e063-6394a90aa8c7	2026-09-01	Warnings	Exact identifier application number: M020
Sun Wave Anti Aging Insta Dry SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	2d5fa597-08a8-41ca-ba9e-b52e41a5c70c	2026-09-01	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
61354-086-01	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