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 167 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Well People Bio Tint SPF 30 Sunscreen 8N	ZINC OXIDE	e.l.f. Cosmetics, Inc	c8aa662c-0f06-712b-e053-2995a90aae0b	2025-11-07	Warnings	Exact identifier application number: M020
Well People Lip Butter SPF 15 Sunscreen AFTERGLOW	ZINC OXIDE	e.l.f. Cosmetics, Inc	c8aa9325-4fad-ddf9-e053-2a95a90a6639	2025-11-07	Warnings	Exact identifier application number: M020
Well People Bio Tint SPF 30 Sunscreen 9w	ZINC OXIDE	e.l.f. Cosmetics, Inc	c8a92c58-d981-0948-e053-2a95a90a16f8	2025-11-07	Warnings	Exact identifier application number: M020
Well People Lip Butter SPF 15 Sunscreen WINE	ZINC OXIDE	e.l.f. Cosmetics, Inc	c8aa873e-8271-8cf0-e053-2995a90a3cec	2025-11-07	Warnings	Exact identifier application number: M020
Well People Lip Butter SPF 15 Sunscreen NATURAL	ZINC OXIDE	e.l.f. Cosmetics, Inc	c8aa7ae9-7d03-db7d-e053-2995a90ae72b	2025-11-07	Warnings	Exact identifier application number: M020
Neutrogena Clear Face Serum Fragrance Free SPF 60 Plus	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Kenvue Brands LLC	eb705402-f8cb-5079-e053-2a95a90a405c	2025-11-06	Warnings	Exact identifier application number: M020
Neutrogena Cool Dry Sport Sunscreen Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	5c1a0437-c269-4cd3-b91a-e2de799b853e	2025-11-06	Warnings	Exact identifier application number: M020
Neutrogena Clear Face Breakout Free oil Free Sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	10ca67ca-c372-44a9-8933-84cce9fb9934	2025-11-06	Warnings	Exact identifier application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	0464448b-342b-4e54-a20e-6ec6bd622889	2025-11-06	Warnings	Exact identifier application number: M020
Neutrogena Hydro Boost Water Gel Sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	7f60d6bd-1735-4390-bc8a-e3876ab7ad50	2025-11-06	Warnings	Exact identifier application number: M020
Neutrogena Hydro Boost Hyaluronic Acid Moisturizer with Sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	ea876490-979b-401c-a6bf-35649e7deda0	2025-11-06	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Moisturizing Face Serum Sunscreen Broad Spectrum SPF 60 Plus	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	cdbe250b-2b64-78fd-e053-2995a90a6c33	2025-11-06	Warnings	Exact identifier application number: M020
Aveeno Favorites	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Kenvue Brands LLC	f3c925cc-7993-70bb-e053-2a95a90abdde	2025-11-06	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF45	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	2510d9fe-2aa7-44ee-9525-ad5163dfee94	2025-11-06	Warnings	Exact identifier application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 60 Plus	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	39710a1a-fe8c-41f2-b60c-db3e99d60a86	2025-11-06	Warnings	Exact identifier application number: M020
Neutrogena Boost Your Skins Vitals Team Regenerate	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	0acd9110-4ba5-227a-e063-6294a90ad942	2025-11-06	Warnings	Exact identifier application number: M020
Neutrogena Clear Face Breakout Free Oil Free Broad Spectrum SPF 55	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	Kenvue Brands LLC	3e25a4ce-dbdd-4830-a3d8-a2dfb3bcb078	2025-11-06	Warnings	Exact identifier application number: M020
Neutrogena Oil Free Moisture Broad Spectrum SPF15	AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	Kenvue Brands LLC	18303bc2-2e00-4a9e-900f-86397ca9d163	2025-11-06	Warnings	Exact identifier application number: M020
Neutrogena Invisible Daily Defense Fragrance Free SPF 60 Plus	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Kenvue Brands LLC	eb7022e7-0929-fdb4-e053-2995a90a9e6c	2025-11-06	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 55 Clubtray	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	0bd538e9-7716-9bc2-e063-6294a90a9a07	2025-11-06	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
78518-003-01	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