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 196 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sun Bum Daily Sunscreen Mist Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3a796a0b-8021-9a9f-e063-6294a90a6eb2	2025-08-15	Warnings	Exact identifier application number: M020
SOLARA SUNCARE - DAY DREAMER SPF 30	ZINC OXIDE	SOLARA SUNCARE, INC.	3c6c9266-a7ff-19f4-e063-6294a90a6096	2025-08-15	Warnings	Exact identifier application number: M020
Sun Bum Mineral 30 Sheer Sunscreen Face	ZINC OXIDE	Sun Bum, LLC	3b00c2d6-a55d-0a56-e063-6294a90ac4b8	2025-08-15	Warnings	Exact identifier application number: M020
Sun Bum Mineral 30 Sunscreen 3 OZ	ZINC OXIDE	Sun Bum, LLC	3b014bd6-ba40-9003-e063-6394a90ab451	2025-08-15	Warnings	Exact identifier application number: M020
Ocean Potion Suncare Mineral 30 Zinc Oxide Sunscreen	ZINC OXIDE	GNL BRANDS INTERNATIONAL, LLC	3c6e7e62-4313-cbce-e063-6394a90ac382	2025-08-15	Warnings	Exact identifier application number: M020
Ocean Potion Face with Clear Zinc Oxide Broad Spectrum SPF 50 Sunscreen	OCTOCRYLENE, ZINC OXIDE	GNL BRANDS INTERNATIONAL, LLC	3c6f3e0b-2dff-6dc3-e063-6394a90abb0e	2025-08-15	Warnings	Exact identifier application number: M020
EltaMD UV Daily Hydration	OCTISALATE, ZINC OXIDE SUNSCREEN	CP Skin Health Group, Inc.	bfdb266b-9920-4225-84c7-bcbad81fd1c7	2025-08-15	Warnings	Exact identifier application number: M020
Sun Bum 70 Premium Moisturizing Sunscreen 8 OZ	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	39fb5e66-5172-3b83-e063-6394a90aab2d	2025-08-14	Warnings	Exact identifier application number: M020
Sun Bum Face Cream 50 Premium Sunscreen	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	Sun Bum, LLC	3c57fcf7-7816-8197-e063-6394a90af80a	2025-08-14	Warnings	Exact identifier application number: M020
Sun Bum 50 Premium Moisturizing Sunscreen Roll-On	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3c58c9c7-ca9e-d012-e063-6394a90a5aa9	2025-08-14	Warnings	Exact identifier application number: M020
Sun Bum 30 Premium Moisturizing Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3a003d82-90bd-f541-e063-6394a90ac906	2025-08-14	Warnings	Exact identifier application number: M020
Sun Bum 50 Premium Moisturizing Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3a00e4fb-6bf2-4c44-e063-6294a90a61bf	2025-08-14	Warnings	Exact identifier application number: M020
Sun Bum 15 Premium Moisturizing Sunscreen 8 OZ	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3a0f99df-e6c0-71d9-e063-6294a90a4c9e	2025-08-14	Warnings	Exact identifier application number: M020
Sun Bum 50 Mineral Sunscreen	ZINC OXIDE	Sun Bum, LLC	3a13d4f1-c158-7fa0-e063-6294a90a6fb4	2025-08-14	Warnings	Exact identifier application number: M020
Sun Bum Kids 50 Clear Sunscreen Face Stick	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3a147fe1-0dda-5433-e063-6394a90a1a59	2025-08-14	Warnings	Exact identifier application number: M020
Sun Bum 15 Premium Sunscreen Browning	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3c5b0db8-f05a-2b5c-e063-6294a90ae79b	2025-08-14	Warnings	Exact identifier application number: M020
Sun Bum 50 Premium Moisturizing Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3aaf7d28-b306-b416-e063-6294a90a021e	2025-08-14	Warnings	Exact identifier application number: M020
Sun Bum 50 Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Sun Bum, LLC	3a263b85-e7a0-c068-e063-6294a90a49f2	2025-08-14	Warnings	Exact identifier application number: M020
Sun Bum 50 Mineral Sunscreen Roll-On	TITANIUM DIOXIDE, ZINC OXIDE	Sun Bum, LLC	3a392237-019d-2384-e063-6394a90a5b24	2025-08-14	Warnings	Exact identifier application number: M020
Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - Bonfire	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	Sun Bum, LLC	3a3b3b4a-148c-1dc5-e063-6394a90a7bdb	2025-08-14	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