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 93 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Coppertone Pure and Simple Baby Sunscreen SPF 50	ZINC OXIDE 24.08%	Beiersdorf Inc	08134b95-1879-27e5-e063-6294a90a29af	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Oil Free SPF 50 Sunscreen	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 4.5%, OCTOCRYLENE 8%	Beiersdorf Inc	ded1f158-36d1-153f-e053-2995a90ace30	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Pure and Simple Kids Suncreen SPF 50	ZINC OXIDE 24.08%	Beiersdorf Inc	08147940-0e8b-c894-e063-6394a90af8ac	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPF 70	AVOBENZONE 3%, HOMOSALATE 13%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%	Beiersdorf Inc	e468d703-fa6c-095a-e053-2a95a90a5194	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50	ZINC OXIDE 24.08%	Beiersdorf Inc	0806bdb9-961f-3146-e063-6294a90a4625	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPL 15	AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%	Beiersdorf Inc	df4b522e-93d4-1284-e053-2a95a90a1cd9	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Pure and Simple Baby Sunscreen SPF 50	ZINC OXIDE 24.08%	Beiersdorf Inc	088b7152-d3d1-9e74-e063-6394a90a4152	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPF 50	(TO DELIVER) AVOBENZONE 3%, HOMOSALATE 10%,OCTISALATE 5%, OCTOCRYLENE 5%	Beiersdorf Inc	0a5a40ff-a014-3995-e063-6394a90a11e6	2025-12-31	Warnings	Exact identifier application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Deep	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47461ad3-a11e-2a11-e063-6294a90a0f8f	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Oil Free Sunscreen SPF 30	AVOBENZONE 3%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 6%	Beiersdorf Inc	e451ecfb-cf17-c622-e053-2a95a90a4d4b	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Pure and Simple Sunscreen SPF 50	ZINC OXIDE 24.08%	Beiersdorf Inc	081484f8-58f5-f2a4-e063-6394a90a3379	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Pure and Simple Kids Sunscreen SPF 50	ZINC OXIDE (24.08%)	Beiersdorf Inc	09a97e3f-f6dc-eaa7-e063-6294a90ad274	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Kids Roll-On Sunscreen SPF 50	ZINC OXIDE 24.08%	Beiersdorf Inc	f3e1ea21-4a07-3e18-e053-2995a90a0fe7	2025-12-31	Warnings	Exact identifier application number: M020
Eucerin Sensitive Mineral Face Sunscreen SPF 35	ZINC OXIDE 24%	Beiersdorf Inc	f3a8bb6b-f051-5d39-e053-2a95a90adafc	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Limited Edition Sunscreen SPF 30	AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%	Beiersdorf Inc	f41e09bf-407d-65a4-e053-2a95a90a2436	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Glow Hydragel SPF 50	AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%	Beiersdort Inc	b5f7cacb-92b9-a6b7-e053-2a95a90aea02	2025-12-31	Warnings	Exact identifier application number: M020
Eucerin Advanced Hydration Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Beiersdorf Inc	cd6112fe-89e4-a79b-e053-2a95a90ad7f4	2025-12-31	Warnings	Exact identifier application number: M020
Eucerin Age Defense SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Beiersdort Inc	cd9d4f30-fb37-9935-e053-2995a90a9936	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPF 70	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%	Beiersdorf Inc	cc5d1f9b-2c8a-1392-e053-2a95a90acb9e	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Every Tone Brightening Sunscreen SPF 60	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Beiersdorf Inc	23e368db-4b2f-d23b-e063-6394a90a1f06	2025-12-31	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