Cream

Product NDC: 78518-003
11-digit product format: 785180003
Labeler code: 78518
Product ID: 78518-003_46e0c74f-30d5-6c24-e063-6394a90ad487
Type: HUMAN OTC DRUG
Nonproprietary name: ZINC OXIDE
Dosage form: CREAM
Route: TOPICAL
Labeler: MONAT GLOBAL CORP
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-09-12
Substance: ZINC OXIDE
Active strength: 18.8 mg/100mg
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78518-003-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78518-003-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78518-003-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78518-003-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78518-003-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78518-003-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78518-003-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	78518-003-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	78518-003-01	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Cream
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	18.8 mg/100mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e92288bb-739a-2f73-e053-2995a90ac01f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d1c9d1af-bddd-448d-86f7-69052b7d5b47	Product name	1	20220627
124351b2-6dbf-42d0-9ea7-f0e299215f9a	Product name	1	20210115

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
78518-003-01	2024-01-11	C162847	48780-1	0191ceaa-6e66-198a-e063-dbdaa90aec3e	BB Cream SPF 40 Broad-Spectrum Moisturizer (Caramel)
78518-003-01	2023-07-28	C162847	48780-1	0191ceaa-6e66-198a-e063-dbdaa90aec3e	BB Cream SPF 40 Broad-Spectrum Moisturizer (Caramel)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
78518-003-01	Cream	1 in 1 CARTON	CREAM	1		4
78518-003-01	Cream	35 mg in 1 TUBE	CREAM	35		4

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 135 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Join
Mineral Lip Sunscreen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	DR. CARIN GRIBETZ BOARD CERTIFIED DERMATOLOGIST	3728ec6a-7de5-bbc5-e063-6294a90a31b7	2025-12-11	Exact identifier application number: M020
SUNerchi Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	SYNERCHI MED SPA, INC.	37db5721-2b32-d4d8-e063-6294a90a47d7	2025-12-11	Exact identifier application number: M020
SUNerchi Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	SYNERCHI MED SPA, INC.	37db14e1-f995-b649-e063-6294a90afd69	2025-12-11	Exact identifier application number: M020
208	ZINC OXIDE	PETER L. KOPELSON, M.D.	351ce033-6bd0-574e-e063-6394a90af448	2025-12-11	Exact identifier application number: M020
208	ZINC OXIDE	PETER L. KOPELSON, M.D.,	351c9727-d7ac-9c3f-e063-6294a90a7721	2025-12-11	Exact identifier application number: M020
Replenishing Daily Protection Tinted	ZINC OXIDE	MY FAVORITE PLACE SPA LLC	351c0c1e-5712-1e23-e063-6394a90abe6f	2025-12-11	Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Saving Face Skinspa Inc.	351d27e3-00d4-8d31-e063-6394a90aaf72	2025-12-11	Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Saving Face Skinspa Inc.	351db99e-262f-b67e-e063-6394a90a3418	2025-12-11	Exact identifier application number: M020
Replenishing Daily Protection NT	ZINC OXIDE	MY FAVORITE PLACE SPA LLC	351c5f6f-86e6-7219-e063-6294a90a3745	2025-12-11	Exact identifier application number: M020
Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	DAISY'S SKIN TRANSFORMATION LLC	37d9fbf5-d602-d3dc-e063-6394a90abe53	2025-12-11	Exact identifier application number: M020
Tinted Mineral 40	TITANIUM DIOXIDE, ZINC OXIDE	2301 PLASTIC SURGERY, PLLC	374d53a7-be0b-4d7a-e063-6394a90a37c4	2025-12-11	Exact identifier application number: M020
Daily Protection 40	ZINC OXIDE	2301 PLASTIC SURGERY, PLLC	374d9c77-ed9f-a518-e063-6394a90a34fa	2025-12-11	Exact identifier application number: M020
Tinted Mineral 40	TITANIUM DIOXIDE, ZINC OXIDE	2301 PLASTIC SURGERY, PLLC	374df66d-eb9b-c4a7-e063-6394a90a3cc6	2025-12-11	Exact identifier application number: M020
Daily Protection 40	ZINC OXIDE	2301 PLASTIC SURGERY, PLLC	374e2294-7281-c7b9-e063-6394a90acc89	2025-12-11	Exact identifier application number: M020
Facial Mineral Sunscreen Mineral Protection	TITANIUM DIOXIDE, ZINC OXIDE	CAPE COD SKIN CARE CO. INC.	387f6dd5-3901-0849-e063-6294a90af8bc	2025-12-11	Exact identifier application number: M020
Non - Tinted Mineral Sunscreen	ZINC OXIDE	NEXTEX CORPORATION	35bacfcf-0254-aa0a-e063-6394a90a1475	2025-12-11	Exact identifier application number: M020
Facial Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	LEDUC, XUANTO MD	387e2e59-c5db-c70e-e063-6394a90a2d26	2025-12-11	Exact identifier application number: M020
Facial Mineral Sunscreen Mineral Protection	TITANIUM DIOXIDE, ZINC OXIDE	CAPE COD SKIN CARE CO. INC.	390779a8-4556-27a5-e063-6294a90a1200	2025-12-11	Exact identifier application number: M020
non-tinted sheer matte mineral	TITANIUM DIOXIDE, ZINC OXIDE	NEXTEX CORPORATION	35ba6cc9-0d49-6d0c-e063-6394a90ac7c3	2025-12-11	Exact identifier application number: M020
sheer tinted matte mineral	TITANIUM DIOXIDE, ZINC OXIDE	NEXTEX CORPORATION	35ba9ca7-fe5c-9824-e063-6394a90a5c46	2025-12-11	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
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
78518-003-01	78518000301	1 TUBE in 1 CARTON (78518-003-01) / 35 mg in 1 TUBE	1 tube	2022-09-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BB Cream SPF 40 Broad-Spectrum Moisturizer (Caramel)	MONAT GLOBAL CORP \| OXYGEN DEVELOPMENT	2025-12-26	HUMAN OTC DRUG LABEL	4