COTZ FACE MOISTURE

Product NDC: 58892-360
11-digit product format: 588920360
Labeler code: 58892
Product ID: 58892-360_509d9a74-bc8e-c9c1-e063-6394a90a403d
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: Fallien Cosmeceuticals Ltd.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-02-04
Substance: ZINC OXIDE
Active strength: 160 mg/g
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	58892-360		U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58892-360	58892-360-42	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`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: COTZ FACE MOISTURE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	160 mg/g

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
509d9a74-bc8d-c9c1-e063-6394a90a403d	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58892-360-42	CoTZ Face Moisture	1 in 1 CARTON	CREAM	1	3
58892-360-42	CoTZ Face Moisture	42.5 g in 1 TUBE	CREAM	42.5	3
58892-360-18	COTZ FACE MOISTURE	5 g in 1 TUBE	CREAM	5	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58892-360	COTZ FACE MOISTURE (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]	3	Current NDC, Legacy NDC, 2 package rows	20250112_db682516-6c8f-4009-a9ec-e21dfc64ce15.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 303 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Florida Squeezed SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Florida Squeezed	13696dc6-ae64-4760-e063-6394a90ac192	2024-03-11	Warnings	Exact identifier application number: M020
BB Noir 30 BS SPF30	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs	136a7f66-844c-b16a-e063-6294a90aa975	2024-03-11	Warnings	Exact identifier application number: M020
Brush On Block Sheer Genius SPF 50 Mineral Moisture Universal Tint	ZINC OXIDE	SPF Ventures, LLC	12d27da2-2689-496a-e063-6294a90aaa9f	2024-03-08	Warnings	Exact identifier application number: M020
Avene Multi-Defense Fluid	ZINC OXIDE	Pierre Fabre USA Inc.	1329e56d-1e74-4bcc-e063-6394a90ae0c3	2024-03-08	Warnings	Exact identifier application number: M020
Avene Multi-Defense Fluid Tinted	ZINC OXIDE	Pierre Fabre USA Inc.	132bdf9a-c5d0-e7e5-e063-6394a90a6180	2024-03-08	Warnings	Exact identifier application number: M020
Avene Face Sunscreen SPF 50	ZINC OXIDE	Pierre Fabre USA Inc.	132ce436-a783-2ba0-e063-6394a90a4b70	2024-03-08	Warnings	Exact identifier application number: M020
TROPICAL OTTERS Glitter Sunscreen SPF-50 - Sugar Sparkle	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	6174 INDUSTRIES, LLC	cfd1e0c7-7e4c-41c1-8788-b73f83bf38c9	2024-03-06	Warnings	Exact identifier application number: M020
TROPICAL OTTERS Glitter Sunscreen SPF-50 - Fragrance Free	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	6174 INDUSTRIES, LLC	658b1b20-6540-4f3a-ac9a-170bc8fcba11	2024-03-06	Warnings	Exact identifier application number: M020
Daily Facial Moisturizer SPF 15 EQB	AVOBENZONE 3% OCTOCRYLENE 10%	Walmart	a0c452a9-3e99-41b8-b9b2-c1b57b66f183	2024-03-06	Warnings	Exact identifier application number: M020
Target Up and Up Sport SPF 50	AVOBENZONE, HOMOSALAT, OCTISALATE, OCTOCRYLENE	TARGET CORPORATION	b81b2e7e-6d7f-fa1d-e053-2995a90a7d15	2024-03-06	Warnings	Exact identifier application number: M020
Target Up and Up Reef Conscious Formula SPF 50 Sport Sunscreen	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	TARGET CORPORATION	b5fd43ee-9fa1-13c1-e053-2995a90a364a	2024-03-06	Warnings	Exact identifier application number: M020
Vacation SPF 30 Baby Oil	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Vacation Inc.	f6030311-5287-3aa3-e053-2995a90a1b87	2024-03-06	Warnings	Exact identifier application number: M020
Brush On Block Sun Shine SPF 30 Protective Lip Oil Nude Tint	TITANIUM DIOXIDE/ZINC OXIDE	SPF Ventures LLC	12e5493f-6478-0ff4-e063-6394a90af4f5	2024-03-05	Warnings	Exact identifier application number: M020
Brush On Block Sun Shine SPF 30 Protective Lip Oil Coral	TITANIUM DIOXIDE/ZINC OXIDE	SPF Ventures LLC	12e65634-2e6d-b030-e063-6294a90ad1c4	2024-03-05	Warnings	Exact identifier application number: M020
Brush On Block Sun Shine SPF 30 Protective Lip Oil Fig	TITANIUM DIOXIDE/ZINC OXIDE	SPF Ventures LLC	12e7507d-6612-fda4-e063-6294a90a1db7	2024-03-05	Warnings	Exact identifier application number: M020
Dermachange SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Private Label Beauty and Wellness	12f00cee-dd9b-19b1-e063-6294a90adccb	2024-03-05	Warnings	Exact identifier application number: M020
Brush On Block Quick Stick SPF 40 Mineral Stick	ZINC OXIDE	SPF Ventures LLC	12d10ec9-847a-7483-e063-6294a90a42a7	2024-03-04	Warnings	Exact identifier application number: M020
Lucin Organics Tinted Sunscreen SPF 30 Non Nano Zinc Oxide	ZINC OXIDE	Lucin Organics, LLC	d717dda8-60bb-40a0-86f9-6d724d695d16	2024-03-04	Warnings	Exact identifier application number: M020
Brush On Block Bounce Butter SPF 30 Moisturizing Mousse	ZINC OXIDE	SPF Ventures LLC	12956754-b4e5-0203-e063-6294a90a2b96	2024-03-01	Warnings	Exact identifier application number: M020
Derma E Sun Protection Mineral SPF 30	ZINC OXIDE	derma e	bb8e3df2-23e8-4ad0-a662-ff02d156e7b1	2024-02-26	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
58892-360-18	58892036018	5 g in 1 TUBE (58892-360-18)	5 g	2019-02-04		No	No	Current
58892-360-42	58892036042	1 TUBE in 1 CARTON (58892-360-42) / 42.5 g in 1 TUBE	1 tube	2019-02-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
COTZ FACE MOISTURE - Fallien Cosmeceuticals Ltd. \| Fragrance Manufacturing Inc. \| Custom Analytics LLC	Fallien Cosmeceuticals Ltd. \| Fragrance Manufacturing Inc. \| Custom Analytics LLC	2026-04-29	HUMAN OTC DRUG LABEL	1
Drug Facts	Fallien Cosmeceuticals, LTD \| Custom Analytics LLC \| Fragrance Manufacturing Inc. (FMI)	2025-01-09	HUMAN OTC DRUG LABEL	3