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 111 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Covergirl Clean Fresh Blurring Skintint SPF 30 Mineral Sunscreen Liquid Foundation- All shades	ZINC OXIDE	Noxell	3fa58ac5-f45c-369a-e063-6294a90a46e4	2025-12-17	Warnings	Exact identifier application number: M020
Ray Defense Broad Spectrum SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Bioelements	807db1ff-a64a-44e4-a786-f88cd4518433	2025-12-17	Warnings	Exact identifier application number: M020
SPF 50 Face Sunscreen Bioelements	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Bioelements, Inc	981c7b3c-d7d6-483d-bf32-10d526be5b3f	2025-12-17	Warnings	Exact identifier application number: M020
Glow Oil SPF 50 Beach Flower	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	2a46d7d2-293f-5024-e063-6294a90a31aa	2025-12-17	Warnings	Exact identifier application number: M020
Coppertone Tanning Sunscreen SPF 15	AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%	Beiersdorf Inc	0f114022-daaa-1834-e063-6394a90afd1d	2025-12-17	Warnings	Exact identifier application number: M020
Coppertone Tanning Sunscreen SPF 8	AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%	Beiersdorf Inc	0f113048-adfb-7d2a-e063-6294a90a2012	2025-12-17	Warnings	Exact identifier application number: M020
Coppertone Oil Free and Shine Control Face Sunscreen SPF 45	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%	Beiersdorf Inc	f3d163b4-6774-4c2e-e053-2a95a90afd59	2025-12-17	Warnings	Exact identifier application number: M020
Coppertone EveryTone Face Sunscreen SPF 55	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Beiersdorf Inc	04b12f39-778c-ecee-e063-6394a90afa24	2025-12-17	Warnings	Exact identifier application number: M020
Skin On Skin BC Foundation SPF 40 - Fair Cool	OCTISALATE, HOMOSALATE, ZINC OXIDE	YENSA Beauty, LLC	462e9a4a-ef28-0e0e-e063-6394a90ab4f8	2025-12-17	Warnings	Exact identifier application number: M020
Mattifying Primer SPF 20	TITANIUM DIOXIDE AND ZINC OXIDE	Colorescience	b27d7df0-3c84-4cc5-9ef3-07105311fed9	2025-12-17	Warnings	Exact identifier application number: M020
Cetaphil Redness Relieving Daily Facial Moisturizer with sunscreen SPF 40	TITANIUM DIOXIDE, ZINC OXIDE	Galderma Laboratories, L.P.	45d101be-2b88-4759-9ccc-556f5ec0553d	2025-12-17	Warnings	Exact identifier application number: M020
Brightening Primer SPF 20	TITANIUM DIOXIDE AND ZINC OXIDE	Colorescience	a42d6761-47cd-4c9b-9656-64e37e065639	2025-12-17	Warnings	Exact identifier application number: M020
Avail Body with Sunscreen	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Emeis Cosmetics Pty Ltd	4bb39ea1-f948-4357-b425-0cafd454ce30	2025-12-17	Warnings	Exact identifier application number: M020
Bronzing Primer SPF 20	TITANIUM DIOXIDE AND ZINC OXIDE	Colorescience	f749af07-0fcd-4376-be62-7c078b3e7eb6	2025-12-17	Warnings	Exact identifier application number: M020
Miffy Tone Perfecting SPF Cushion	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	RBGROUP Co., Ltd	98a2906d-61e2-4627-a695-a20f10872f9a	2025-12-16	Warnings	Exact identifier application number: M020
Dear Sun Tone Perfecting SPF Cushion	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	RBGROUP Co., Ltd	80748647-e0ea-46dc-8ee2-a0ad77c4b19d	2025-12-16	Warnings	Exact identifier application number: M020
SUNSCREEN Stick	ZINC OXIDE 15%, TITANIUM DIOXIDE 8%, HOMOSALATE 6%	Foshan Sugar Max Cosmetics CO.,Ltd	460e1038-30f0-a6e4-e063-6394a90ad534	2025-12-16	Warnings	Exact identifier application number: M020
SUNSCREEN SPRAY150ml	ZINC OXIDE 15%, TITANIUM DIOXIDE 6%, HOMOSALATE 5%, OCTISALATE 4%	Foshan Sugar Max Cosmetics CO.,Ltd	460ead6c-dd44-e320-e063-6294a90a2b64	2025-12-16	Warnings	Exact identifier application number: M020
Sunscreen Cream	ZINC OXIDE 12%,TITANIUM DIOXIDE 8%, HOMOSALATE 12%, OCTISALATE4.5%,PHENYLBENZIMIDAZOLE SULFONIC ACID 3.5%	Foshan Sugar Max Cosmetics CO.,Ltd	460f0ca0-9440-9a6e-e063-6394a90a33b3	2025-12-16	Warnings	Exact identifier application number: M020
Unseen Sunscreen Lip Protector SPF 30	OCTOCRYLENE, AVOBENZONE, HOMOSALATE, OCTISALATE	Supergoop LLC	db12a89f-5fef-1b2a-e053-2a95a90a56f9	2025-12-16	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