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 100 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ageless Glow Serum BB Cream Sunscreen SPF 40 - Fair	HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	473738b4-7c36-8edf-e063-6394a90ad24b	2025-12-30	Warnings	Exact identifier application number: M020
Ageless Glow Serum BB Cream Sunscreen SPF 40 - Medium Tan	HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47387d5f-e77b-5633-e063-6294a90a5584	2025-12-30	Warnings	Exact identifier application number: M020
Ageless Glow Serum BB Cream Sunscreen SPF 40 - Tan	HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4738be66-0fe8-148e-e063-6394a90a1b02	2025-12-30	Warnings	Exact identifier application number: M020
Ageless Glow Serum BB Cream Sunscreen SPF 40 - Tan Deep	HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4738eed1-9f72-5fd8-e063-6394a90a26bd	2025-12-30	Warnings	Exact identifier application number: M020
Ageless Glow Serum BB Cream Sunscreen SPF 40 - Deep	HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4739179e-88b3-8820-e063-6394a90aa211	2025-12-30	Warnings	Exact identifier application number: M020
WHITE TEA TINTED MOISTURIZER	WHITE TEA TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN	GLOW CONCEPT INC	eb2df93f-6cdc-7ae8-e053-2a95a90a0091	2025-12-29	Warnings	Exact identifier application number: M020
Hawaiian Natural Zinc Sunscreen SPF 50	ZINC OXIDE	Kokua Sun Care	64a5589b-735d-38ba-e053-2a91aa0ad8f4	2025-12-29	Warnings	Exact identifier application number: M020
Hawaiian Natural Zinc Sunscreen Broad Spectrum Tinted SPF 30	ZINC OXIDE	Kokua Sun Care	f9a12dac-2fd0-798f-e053-6394a90aa784	2025-12-29	Warnings	Exact identifier application number: M020
Calming Days Vegan Sunscreen	,OCTYL TRIAZONE (ETHYLHEXYL TRIAZONE), BISOCTRIZOLE, DIETHYLHEXYL BUTAMIDO TRIAZONE, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE	MERCYCO Co., Ltd.	38898014-eefe-73ec-e063-6394a90a3738	2025-12-29	Warnings	Exact identifier application number: M020
SPF 30 Sunscreen	ZINC OXIDE, TITANIUM DIOXIDE	CLEURE	f5512f34-08ee-b0f6-e053-2a95a90ab5bd	2025-12-29	Warnings	Exact identifier application number: M020
COCO AND EVE SUNNY HONEY PROTECT TAN BOOSTING ANTI-AGING SPF 20	SUNSCREEN OIL	Soleil Collective LLC	471b3028-2c13-ab70-e063-6394a90aa660	2025-12-29	Warnings	Exact identifier application number: M020
COCO AND EVE SUNNY HONEY PROTECT TAN BOOSTING ANTI-AGING SPF 45	SUNSCREEN OIL	Soleil Collective LLC	471c0eed-f7ca-3c3b-e063-6294a90ad2c6	2025-12-29	Warnings	Exact identifier application number: M020
EIGHT HOUR NOURISHING LIP SPF 20	OCTINOXATE, AVOBENZONE	REVLON	b3c16e60-752d-6eba-e053-2995a90a2b20	2025-12-29	Warnings	Exact identifier application number: M020
CERAMIDE PREMIERE BROAD SPECTRUM SPF 30	OCTINOXATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONE	REVLON	b3358bfd-7fe5-33e2-e053-2a95a90ac2ea	2025-12-29	Warnings	Exact identifier application number: M020
Prevage anti aging SPF 30	OCTISALATE, OCTINOXATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE,	Revlon	b2bff796-1579-2686-e053-2995a90ad6c7	2025-12-29	Warnings	Exact identifier application number: M020
FLAWLESS FUTURE SPF 30	OCTINOXATE, OCTISALATE, OXYBENZONE, AVAOBENZONE	REVLON	b553aec1-5002-3a3f-e053-2995a90a22e5	2025-12-29	Warnings	Exact identifier application number: M020
Prevage Anti-aging eye cream SPF 15	OCTINOXATE, OXYBENZONE	Revlon	b2a92d72-e634-7379-e053-2995a90a2bca	2025-12-29	Warnings	Exact identifier application number: M020
Prevage Anti-aging Moisture Cream	OCTINOXATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONE	Revlon Consumer Products Corp	b247adbe-dfe8-df0a-e053-2995a90a34d9	2025-12-29	Warnings	Exact identifier application number: M020
Sheer Protection SPF 30	ZINC OXIDE	Skin Script, LLC	0450dcc9-3f8f-e2c2-e063-6294a90af60b	2025-12-29	Warnings	Exact identifier application number: M020
RE-NUTRIV ULTRA RADIANCE MAKEUP BROAD SPECTRUM SPF 20	OCTINOXATE AND TITANIUM DIOXIDE	ESTEE LAUDER INC	897b8edb-f089-4a49-baca-e05806b0a068	2025-12-29	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