Cream

Product NDC: 78518-007
11-digit product format: 785180007
Labeler code: 78518
Product ID: 78518-007_46e05ccb-82a8-f692-e063-6294a90a079a
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	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	78518-007-01	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	78518-007-01	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	78518-007-01	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	78518-007-01	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	78518-007-01	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	78518-007-01	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	78518-007-01	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	78518-007-01	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	78518-007-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

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

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
e9231470-9292-0e70-e053-2a95a90a767a	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#

Effective, Related label table
Effective	Related label
2025-12-26	BB Cream SPF 40 Broad-Spectrum Moisturizer (Porcelain)
2025-01-30	BB Cream SPF 40 Broad-Spectrum Moisturizer (Porcelain)
2023-08-11	BB Cream SPF 40 Broad-Spectrum Moisturizer (Porcelain)
2023-07-28	BB Cream SPF 40 Broad-Spectrum Moisturizer (Porcelain)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
78518-007-01	Cream	1 in 1 CARTON	CREAM	1		3
78518-007-01	Cream	35 mg in 1 TUBE	CREAM	35		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78518-007	CREAM (ZINC OXIDE) CREAM [MONAT GLOBAL CORP]	2	Current NDC, Legacy NDC, 2 package rows	20230812_e9231470-9292-0e70-e053-2a95a90a767a.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 87 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hawaiian Blend Sensitive Zinc SPF 50	ZINC OXIDE, TITANIUM DIOXIDE	The Islander Group	b42261c5-fa6e-4bb3-93c0-97032ab9f716	2026-01-07	Warnings	Exact identifier application number: M020
CabanaMilk Mineral Barrier Fluid SPF 50	ZINC OXIDE	NAKED SUNDAYS PTY LTD	47d0fe4d-ad21-1004-e063-6394a90a9c19	2026-01-07	Warnings	Exact identifier application number: M020
CENTELLA RELIEF SOOTHING SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	IUNIK Co., Ltd.	47d170e3-dd76-d413-e063-6294a90ae8e4	2026-01-07	Warnings	Exact identifier application number: M020
Round Lab Birch Juice Mild-Up UVLOCK Sunscreen SPF50 Broad Spectrum	ZINC OXIDE	SEORIN COMPANY Co., Ltd.	1e7cc417-3c57-c87c-e063-6394a90a670b	2026-01-07	Warnings	Exact identifier application number: M020
Proactiv Clear Skin SPF 30	AVOBENZONE, OCTISALATE, AND OCTOCRYLENE	Alchemee, LLC	b0aa7ff0-f712-486f-aaaf-f88fed3b5cd1	2026-01-07	Warnings	Exact identifier application number: M020
Daily Hydrating Mineral Body Sunscreen Broad Spectrum SPF 30 Sunscreen	ZINC OXIDE	Oak Essentials, LLC	47d37f44-10b2-214f-e063-6294a90a5abc	2026-01-07	Warnings	Exact identifier application number: M020
PLUMSCREEN SPF 31	ZINC OXIDE	Le Prunier Farms, Inc.	e20eb996-2b64-6bd0-e053-2a95a90a4f92	2026-01-07	Warnings	Exact identifier application number: M020
BETA-GLUCAN MILD SUNSCREEN	TITANIUM DIOXIDE, ZINC OXIDE	IUNIK Co., Ltd	47d6ad8b-1081-ee21-e063-6294a90a0e63	2026-01-07	Warnings	Exact identifier application number: M020
Koobarra Mineral Face Sunscreen SPF 50	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	37cf8143-99f2-cca5-e063-6394a90a19a8	2026-01-07	Warnings	Exact identifier application number: M020
Solar Swipe Mineral Sunscreen SPF50	SOLAR SWIPE MINERAL SUNSCREEN SPF50	Guangzhou Fantesy Biotechnology Co.,Ltd	47d75d61-5295-3eab-e063-6394a90a01c1	2026-01-07	Warnings	Exact identifier application number: M020
LUXURY SUN RITUAL PORE SMOOTHING SPF 30 SUNSCREEN	ZINC OXIDE	JANE STREET LLC	dbdd3e6a-f09d-90cf-e053-2a95a90a98a0	2026-01-07	Warnings	Exact identifier application number: M020
RENEWALUXE SPF 50 Sunscreen	RENEWALUXE SPF 50 SUNSCREEN	Guangzhou Fantesy Biotechnology Co.,Ltd	1bc29960-5e73-e8ab-e063-6294a90a3f80	2026-01-06	Warnings	Exact identifier application number: M020
ULTRA VIOLETTE VELVET SCREEN BLURRING MINERAL SKINSCREEN	SPF50	Wild Child Laboratories PTY Ltd	2767ba3e-7434-d474-e063-6294a90aa4ff	2026-01-06	Warnings	Exact identifier application number: M020
ULTRA VIOLETTE SPF ON THE GLOW Duo Pack Kit	SPF 50	Grace And Fire USA Inc.	47b7da8a-ea89-1402-e063-6294a90a23f9	2026-01-06	Warnings	Exact identifier application number: M020
Hawaiian Blend Essential Zinc SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Islander Group	5a6e622f-2c00-406a-8860-d7081656f597	2026-01-06	Warnings	Exact identifier application number: M020
SHISEIDO SYNCHRO SKIN LASTING Liquid FOUNDATION Neutral 5	OCTINOXATE AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	66c22f17-5418-42ff-97b2-33fa10f5eac3	2026-01-06	Warnings	Exact identifier application number: M020
SHISEIDO BENEFIANCE WRINKLERESIST24 DAY	AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE	SHISEIDO AMERICAS CORPORATION	7d9c0f81-005f-4223-940e-a64143db5275	2026-01-06	Warnings	Exact identifier application number: M020
SHISEIDO FUTURE Solution LX INFINITE TREATMENT PRIMER	TITANIUM DIOXIDE, OCTINOXATE, AND ENSULIZOLE	SHISEIDO AMERICAS CORPORATION	ff088b0c-27c9-4ea8-bf94-6261378c7190	2026-01-06	Warnings	Exact identifier application number: M020
Drs. pharmacy sunscreen SPF 50 (physical filters)	SUNSCREEN SPF 50	OL PHARMA TECH LLC. (Drs. Pharmacy)	31e976a2-0623-0dca-e063-6394a90a08da	2026-01-06	Warnings	Exact identifier application number: M020
SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 115 Fair Shirakaba	OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	26151cf4-0fee-4a42-92fd-4d7b9cef8381	2026-01-06	Warnings	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
78518-007-01	78518000701	1 TUBE in 1 CARTON (78518-007-01) / 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 (Porcelain)	MONAT GLOBAL CORP \| OXYGEN DEVELOPMENT, LLC	2025-12-26	HUMAN OTC DRUG LABEL	3