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 82 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Blue Lizard Baby SPF 50 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Crown Laboratories	32d6e04a-fa30-ba48-e063-6394a90a1bbf	2026-01-12	Warnings	Exact identifier application number: M020
Blue Lizard Kids SPF 50 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Crown Laboratories	2f780daa-4c91-5a68-e063-6394a90afd41	2026-01-12	Warnings	Exact identifier application number: M020
Blue Lizard Sensitive SPF 50	ZINC OXIDE	Crown Laboratories	99839894-9695-2cd1-e053-2995a90acba6	2026-01-12	Warnings	Exact identifier application number: M020
Blue Lizard SPF 15 Lip Balm	ZINC OXIDE	Crown Laboratories	1bf8fb7e-9d5b-86d4-e063-6294a90afddc	2026-01-12	Warnings	Exact identifier application number: M020
Blue Lizard Kids SPF 50	ZINC OXIDE	Crown Laboratories	9983563c-1e63-0748-e053-2a95a90a971e	2026-01-12	Warnings	Exact identifier application number: M020
Blue Lizard Baby SPF 50	ZINC OXIDE	Crown Laboratories	9948f5b8-43bd-1c99-e053-2a95a90a6121	2026-01-12	Warnings	Exact identifier application number: M020
Blue Lizard Sheer SPF 50 Sunscreen	ZINC OXIDE	Crown Laboratories	3368f1cb-c341-e886-e063-6394a90a9b7c	2026-01-12	Warnings	Exact identifier application number: M020
Blue Lizard Sport SPF 50 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Crown Laboratories	2f3844d8-0367-aad9-e063-6294a90a1fce	2026-01-12	Warnings	Exact identifier application number: M020
Blue Lizard Sheer Face SPF 50 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Crown Laboratories	30cd79da-2f25-a42a-e063-6394a90a8332	2026-01-12	Warnings	Exact identifier application number: M020
ACCOJE PROTECTIVE AIR-FIT MINERAL SUNSCREEN	TITAMIUN DIOXIDE, ZINC OXIDE	UCL Co., Ltd.	4837b4f6-ada9-801a-e063-6294a90a8547	2026-01-12	Warnings	Exact identifier application number: M020
Intellishade Original SPF 45	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	Revision, LLC	e213a681-eb22-69c0-e053-2995a90a899e	2026-01-12	Warnings	Exact identifier application number: M020
GINZING SPF 40 ENERGY-BOOSTING TINTED MOISTURIZER BROAD SPECTRUM SPF 40 SHEER TINT RELEASE	HOMOSALATE,OCTINOXATE,OCTISALATE, AND ZINC OXIDE	ORIGINS NATURAL RESOURCES INC.	48393640-4b97-04de-e063-6294a90aa6a6	2026-01-12	Warnings	Exact identifier application number: M020
Hale and Hush Broad Spectrum SPF 30 SPF 30	ZINC OXIDE	Eclectic Solutions LLC	0530904f-b02c-d8cf-e063-6294a90aa5a7	2026-01-12	Warnings	Exact identifier application number: M020
Minori Daily Mineral Face Sunscreen Broad Spectrum SPF 30	ZINC OXIDE	Minori Inc.	1d4e2654-1638-0d01-e063-6394a90af303	2026-01-12	Warnings	Exact identifier application number: M020
LUXURY BODY RITUAL HYDRATING SPF 30	ZINC OXIDE	JANE STREET LLC	15e9d688-f226-1a19-e063-6394a90ab906	2026-01-12	Warnings	Exact identifier application number: M020
BROAD SPECTRUM SPF50 SPF 50	AVOBENZONE, HOMOSALATE OCTISALATE,	NAKED SUNDAYS PTY LTD	0426b1e9-063b-c1e6-e063-6294a90a2554	2026-01-11	Warnings	Exact identifier application number: M020
SPF30 MINERAL SUNSCREEN MOUSSE	ZINC OXIDE	Aopline Biotechnology (Guangzhou) Co., Ltd.	48031a0f-c2ed-5424-e063-6294a90ad0ff	2026-01-10	Warnings	Exact identifier application number: M020
SPF 30 MINERAL WHIPPED CREAMS SHIMMER	ZINC OXIDE	Aopline Biotechnology (Guangzhou) Co., Ltd.	48037a05-722e-4231-e063-6294a90ac51f	2026-01-10	Warnings	Exact identifier application number: M020
ODLUMIVIE Tinted Mineral Sunscreen	ZINC OXIDE,TITANIUM DIOXIDE	Guangzhou Meijiao Medical Biotechnology Co., Ltd.	480d6e65-f6dc-d2a5-e063-6294a90a24a1	2026-01-10	Warnings	Exact identifier application number: M020
Cloud Brush On Sunscreen Clear Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	FUTURE 8 LLC	9922f132-f6a5-41ca-847a-936b20bf1716	2026-01-09	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