cream

Product NDC: 61354-070
11-digit product format: 613540070
Labeler code: 61354
Product ID: 61354-070_bbf4eee8-49b5-053c-e053-2a95a90add6c
Type: HUMAN OTC DRUG
Nonproprietary name: Octinoxate, Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: Oxygen Development LLC
Application: part352
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2021-02-22
Marketing end: 0000-00-00
Substance: ZINC OXIDE; OCTINOXATE
Active strength: 5 mg/100mg; mg/100mg
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61354-070		I	Inactivated by FDA	2026-10-05
excluded product	product	61354-070		I	Inactivated by FDA	2026-10-05
excluded product	product	61354-070		I	Inactivated by FDA	2026-10-05
excluded product	product	61354-070		I	Inactivated by FDA	2026-10-05
excluded package	package	61354-070	61354-070-05	D	Discontinued by firm	2026-10-05
excluded package	package	61354-070	61354-070-07	D	Discontinued by firm	2026-10-05
excluded package	package	61354-070	61354-070-06	D	Discontinued by firm	2026-10-05
excluded package	package	61354-070	61354-070-08	D	Discontinued by firm	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 2 · 84 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 product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
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 product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61354-070-08	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61354-070-06	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61354-070-07	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61354-070-05	D	Discontinued by firm	`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 product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
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 product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61354-070-08	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61354-070-06	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61354-070-07	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61354-070-05	D	Discontinued by firm	`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 product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
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 product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61354-070-08	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61354-070-06	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61354-070-07	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61354-070-05	D	Discontinued by firm	`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 product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
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 product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61354-070-08	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61354-070-06	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61354-070-07	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61354-070-05	D	Discontinued by firm	`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 product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
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 product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61354-070-08	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61354-070-06	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61354-070-07	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61354-070-05	D	Discontinued by firm	`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 product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
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 product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61354-070-08	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61354-070-06	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61354-070-07	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61354-070-05	D	Discontinued by firm	`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 product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
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 product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61354-070-08	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61354-070-06	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61354-070-07	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61354-070-05	D	Discontinued by firm	`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 product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
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 product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
61354-070-05	2025-01-30	f386c649-9eb5-0266-e053-dadaa90a7c1a	Westmore Beauty 10-in-1 coverage perfector cc cream broad spectrum spf 25 sunscreen - Light
61354-070-06	2025-01-30	f386c649-fb93-0266-e053-dadaa90a7c1a	Westmore Beauty 10-in-1 coverage perfector CC cream broad spectrum spf 25 sunscreen - Deep
61354-070-07	2025-01-30	f386c649-c989-0266-e053-dadaa90a7c1a	Westmore Beauty 10-in-1 coverage perfector CC cream Broad spectrum spf 25 sunscreen - Fair
61354-070-08	2025-01-30	f386c64a-3de1-0266-e053-dadaa90a7c1a	Westmore Beauty 10-in-1 coverage perfector CC cream Broad spectrum spf 25 sunscreen - Medium
61354-070-05	2023-02-10	f386c649-9eb5-0266-e053-dadaa90a7c1a	Westmore Beauty 10-in-1 coverage perfector cc cream broad spectrum spf 25 sunscreen - Light
61354-070-06	2023-02-10	f386c649-fb93-0266-e053-dadaa90a7c1a	Westmore Beauty 10-in-1 coverage perfector CC cream broad spectrum spf 25 sunscreen - Deep
61354-070-07	2023-02-10	f386c649-c989-0266-e053-dadaa90a7c1a	Westmore Beauty 10-in-1 coverage perfector CC cream Broad spectrum spf 25 sunscreen - Fair
61354-070-08	2023-02-10	f386c64a-3de1-0266-e053-dadaa90a7c1a	Westmore Beauty 10-in-1 coverage perfector CC cream Broad spectrum spf 25 sunscreen - Medium
61354-070-05	2023-01-30	f386c649-9eb5-0266-e053-dadaa90a7c1a	Westmore Beauty 10-in-1 coverage perfector cc cream broad spectrum spf 25 sunscreen - Light
61354-070-06	2023-01-30	f386c649-fb93-0266-e053-dadaa90a7c1a	Westmore Beauty 10-in-1 coverage perfector CC cream broad spectrum spf 25 sunscreen - Deep
61354-070-07	2023-01-30	f386c649-c989-0266-e053-dadaa90a7c1a	Westmore Beauty 10-in-1 coverage perfector CC cream Broad spectrum spf 25 sunscreen - Fair
61354-070-08	2023-01-30	f386c64a-3de1-0266-e053-dadaa90a7c1a	Westmore Beauty 10-in-1 coverage perfector CC cream Broad spectrum spf 25 sunscreen - Medium

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61354-070-01	Cream	40 mg in 1 TUBE	CREAM	40	3
61354-070-02	cream	40 mg in 1 TUBE	CREAM	40	3
61354-070-03	cream	40 mg in 1 TUBE	CREAM	40	3
61354-070-04	cream	40 mg in 1 TUBE	CREAM	40	3
61354-070-05	Cream	1 in 1 CARTON	CREAM	1	3
61354-070-06	cream	1 in 1 CARTON	CREAM	1	3
61354-070-07	cream	1 in 1 CARTON	CREAM	1	3
61354-070-08	cream	1 in 1 CARTON	CREAM	1	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61354-070	CREAM (OCTINOXATE, ZINC OXIDE) CREAM [OXYGEN DEVELOPMENT LLC]	3	Legacy NDC, 2 package rows	20230211_bbf4e4ca-8b3b-4298-e053-2995a90ad847.zip
61354-070	CREAM (OCTINOXATE, ZINC OXIDE) CREAM [OXYGEN DEVELOPMENT LLC]	3	Legacy NDC, 2 package rows	20230211_bbf07182-f7d7-3790-e053-2a95a90a3798.zip
61354-070	CREAM (OCTINOXATE, ZINC OXIDE) CREAM [OXYGEN DEVELOPMENT LLC]	3	Legacy NDC, 2 package rows	20230211_bbf2abeb-fe02-8422-e053-2a95a90ac374.zip
61354-070	CREAM (OCTINOXATE, ZINC OXIDE) CREAM [OXYGEN DEVELOPMENT LLC]	3	Legacy NDC, 2 package rows	20230211_bbf3d3af-f30e-5491-e053-2995a90a22bb.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61354-070-01	61354007001	40 mg in 1 TUBE	40 mg					Historical
61354-070-02	61354007002	40 mg in 1 TUBE	40 mg					Historical
61354-070-03	61354007003	40 mg in 1 TUBE	40 mg					Historical
61354-070-04	61354007004	40 mg in 1 TUBE	40 mg					Historical
61354-070-05	61354007005	1 TUBE in 1 CARTON (61354-070-05) > 40 mg in 1 TUBE (61354-070-01)	1 tube	2021-02-22	0000-00-00	No	No	Current
61354-070-06	61354007006	1 TUBE in 1 CARTON (61354-070-06) > 40 mg in 1 TUBE (61354-070-02)	1 tube	2021-02-22	0000-00-00	No	No	Current
61354-070-07	61354007007	1 TUBE in 1 CARTON (61354-070-07) > 40 mg in 1 TUBE (61354-070-03)	1 tube	2021-02-22	0000-00-00	No	No	Current
61354-070-08	61354007008	1 TUBE in 1 CARTON (61354-070-08) > 40 mg in 1 TUBE (61354-070-04)	1 tube	2021-02-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cream	Oxygen Development LLC	2023-02-10	HUMAN OTC DRUG LABEL	3
cream	Oxygen Development LLC	2023-02-10	HUMAN OTC DRUG LABEL	3
cream	Oxygen Development LLC	2023-02-10	HUMAN OTC DRUG LABEL	3
cream	Oxygen Development LLC	2023-02-10	HUMAN OTC DRUG LABEL	3