Cream

Product NDC: 61354-088
11-digit product format: 613540088
Labeler code: 61354
Product ID: 61354-088_e77748ac-2f7b-5fb9-e053-2a95a90a0eaf
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	61354-088		I	Inactivated by FDA		2026-10-12
excluded package	package	61354-088	61354-088-01	I	Inactivated by FDA		2026-10-12

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	61354-088-01	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	61354-088-01	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	61354-088-01	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	61354-088-01	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	61354-088-01	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	61354-088-01	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	61354-088-01	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	61354-088-01	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	61354-088-01	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
61354-088-01	2025-01-30	C162847	48780-1	2cef2736-7b70-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
61354-088-01	Cream	100 mg in 1 TUBE	CREAM	100		1
61354-088-01	Cream	1 in 1 CARTON	CREAM	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61354-088	CREAM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [OXYGEN DEVELOPMENT LLC]	1	Legacy NDC, 2 package rows	20220831_e777457e-b29b-3b1c-e053-2a95a90a0fba.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 13 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VERSED MULTI SERUM SKIN TINT SPF 40 DEEP WRM	ZINC OXIDE	COSMAX USA, CORP	5647ae2c-bcba-63c0-e063-6394a90ad5bc	2026-07-10	Warnings	Exact identifier application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 TAN DEEP WRM	ZINC OXIDE	COSMAX USA, CORP	56478f3d-f25c-bef7-e063-6294a90ade09	2026-07-10	Warnings	Exact identifier application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 TAN DEEP COOL	ZINC OXIDE	COSMAX USA, CORP	564796f8-072f-61f2-e063-6394a90ab394	2026-07-10	Warnings	Exact identifier application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 DEEP COOL	ZINC OXIDE	COSMAX USA, CORP	5647e63c-a695-1b40-e063-6394a90a5767	2026-07-10	Warnings	Exact identifier application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 DEEP NEUTRAL	ZINC OXIDE	COSMAX USA, CORP	5647d0f1-945f-b0b7-e063-6294a90aafe2	2026-07-10	Warnings	Exact identifier application number: M020
LAURA GELLER X BLISS SHINE - N - SHIELD LIP BALM SPF 15 Sunset Sands	ZINC OXIDE	COSMAX USA, CORP	5648da76-5a67-605a-e063-6294a90a4e3b	2026-07-10	Warnings	Exact identifier application number: M020
Coco and Eve Tan Boosting Anti Aging Body Oil SPF 45	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	COSMAX USA, CORP	5648d637-9743-97a7-e063-6294a90ad8a1	2026-07-10	Warnings	Exact identifier application number: M020
The Mineral Lip One SPF 45 Nourishing Lip Tint Vanilla Cloud	ZINC OXIDE	COSMAX USA, CORP	5648c90b-b814-c16e-e063-6394a90a3e1f	2026-07-10	Warnings	Exact identifier application number: M020
The Mineral Lip One SPF 45 Nourishing Lip Tint Berry Balmy	ZINC OXIDE	COSMAX USA, CORP	56490982-200d-e3a7-e063-6394a90a72a4	2026-07-10	Warnings	Exact identifier application number: M020
PRIME Prometics LipOil SPF 35 Warm Sienna	ZINC OXIDE	COSMAX USA, CORP	56491794-712d-1306-e063-6394a90a4707	2026-07-10	Warnings	Exact identifier application number: M020
PRIME Prometics LipOil SPF 35 Bright Berry	ZINC OXIDE	COSMAX USA, CORP	56491833-5053-c85e-e063-6294a90ac4f5	2026-07-10	Warnings	Exact identifier application number: M020
PRIME Prometics LipOil SPF 35 Nude Rose	ZINC OXIDE	COSMAX USA, CORP	56493964-1d5b-2fc7-e063-6394a90a7492	2026-07-10	Warnings	Exact identifier application number: M020
PRIME Prometics LipOil SPF 35 Soft Petal	ZINC OXIDE	COSMAX USA, CORP	5649df7b-9d2c-d8eb-e063-6394a90acf99	2026-07-10	Warnings	Exact identifier application number: M020
PRIME Prometics LipOil SPF 35 Nude Glow	ZINC OXIDE	COSMAX USA, CORP	564a6566-442c-b933-e063-6294a90a6f9b	2026-07-10	Warnings	Exact identifier application number: M020
SOFIE PAVITT FACE SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE	COSMAX USA., CORP	564ae5d2-1504-9623-e063-6394a90a2fa5	2026-07-10	Warnings	Exact identifier application number: M020
IDEALOVE HYDROGLOW DAILY SUNSCREEN SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE	COSMAX USA, CORP	564b284c-3248-c6c0-e063-6394a90a1103	2026-07-10	Warnings	Exact identifier application number: M020
SOFIE PAVITT FACE SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE	COSMAX USA., CORP	564b1ed2-aa98-a334-e063-6294a90a169b	2026-07-10	Warnings	Exact identifier application number: M020
LAURA GELLER X BLISS SHINE - N - SHIELD LIP BALM SPF 15 GOLDEN HOUR	ZINC OXIDE	COSMAX USA, CORP	564b559e-6fe8-e98e-e063-6294a90a8f0e	2026-07-10	Warnings	Exact identifier application number: M020
LAURA GELLER X BLISS SHINE - N - SHIELD LIP BALM SPF 15 BLISS ON THE BEACH	ZINC OXIDE	COSMAX USA, CORP	564b63f2-701e-f5bd-e063-6394a90af797	2026-07-10	Warnings	Exact identifier application number: M020
LAURA GELLER X BLISS SHINE - N - SHIELD LIP BALM SPF 15 GOING COCONUTS	ZINC OXIDE	COSMAX USA, CORP	564b5ab3-0a7c-f663-e063-6394a90a0c3d	2026-07-10	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
61354-088-01	61354008801	1 TUBE in 1 CARTON (61354-088-01) > 100 mg in 1 TUBE	1 tube	2022-08-30	0000-00-00	No	No	Current