CoTZ Face Prime and Protect SPF 40 (Non-Tinted)

Product NDC: 58892-348
11-digit product format: 588920348
Labeler code: 58892
Product ID: 58892-348_9498c109-3155-481c-a847-975cb655f6bc
Type: HUMAN OTC DRUG
Nonproprietary name: Titanium Dioxide, Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: Fallien Cosmeceuticals, LTD
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-11-15
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 80; 38 mg/g; mg/g
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 · 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	58892-348		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	58892-348	58892-348-45	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 Prime and Protect SPF 40 (Non-Tinted)
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TITANIUM DIOXIDE	80 mg/g
ZINC OXIDE	38 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
15FIX9V2JP	Internal UNII lookup
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
f106f52b-2157-46c7-9f7c-50f43a649050	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58892-348-45	CoTZ Face Prime and Protect SPF 40 (Non-Tinted)	42.5 g in 1 TUBE	CREAM	42.5		2
58892-348-45	CoTZ Face Prime and Protect SPF 40 (Non-Tinted)	1 in 1 CARTON	CREAM	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58892-348	COTZ FACE PRIME AND PROTECT SPF 40 (NON-TINTED) (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]	2	Current NDC, Legacy NDC, 2 package rows	20250112_f106f52b-2157-46c7-9f7c-50f43a649050.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 85 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
100% Mineral Broad Spectrum Sunscreen SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Supergoop LLC	d6fcc065-cbcd-0b81-e053-2a95a90ab1f9	2026-01-09	Warnings	Exact identifier application number: M020
Glow Screen Body Broad Spectrum Sunscreen SPF 40	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	b9590938-417d-617a-e053-2995a90a7496	2026-01-09	Warnings	Exact identifier application number: M020
100% Mineral Broad Spectrum Sunscreen SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Supergoop LLC	d7758651-c152-5868-e053-2a95a90ab673	2026-01-09	Warnings	Exact identifier application number: M020
Mineral Sunscreen SPF 30	ZINC OXIDE	Supergoop, LLC	4cf243b4-d794-401a-b209-18c7e550ef4f	2026-01-09	Warnings	Exact identifier application number: M020
Daily Dose Bioretinol Mineral SPF 40	ZINC OXIDE	Supergoop, LLC	eb5bbc70-dbdf-06a8-e053-2995a90a66c1	2026-01-09	Warnings	Exact identifier application number: M020
Unseen Sunscreen Body SPF 40	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	ec1c30bd-76e1-9d00-e053-2a95a90a1759	2026-01-09	Warnings	Exact identifier application number: M020
Glow Screen SPF 40	AVOBENZONE, OCTISALATE, OCTOCYLENE	Supergoop, LLC	21569637-332a-461b-bf6c-33af6a83a155	2026-01-09	Warnings	Exact identifier application number: M020
Glowscreen SPF 40 - Dawn	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	f07145d5-b74d-7757-e053-2a95a90ac4c0	2026-01-09	Warnings	Exact identifier application number: M020
Glowscreen SPF 40 -Sunset	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	f7e493da-8fc6-191d-e053-6294a90aa483	2026-01-09	Warnings	Exact identifier application number: M020
Supergoop Glow Screen SPF 40 Shade 2 Golden Hour	BROAD SPECTRUM SUNSCREEN	Supergoop LLC	d2928dd7-a813-4929-e053-2a95a90aaeb4	2026-01-09	Warnings	Exact identifier application number: M020
Superscreen Hydrating Daily Cream SPF 40	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	ff0e4e97-8f01-bd36-e053-6394a90a47ae	2026-01-09	Warnings	Exact identifier application number: M020
Lipshade SPF 30 Hey Yall	ZINC OXIDE	Supergoop, LLC	f93dfa13-ff18-ee38-e053-6394a90aea46	2026-01-09	Warnings	Exact identifier application number: M020
Triple Prep SPF 40	AVOBENZONE, OCTISALATE, OCTOCRYLENE, HOMOSALATE	Supergoop, LLC	004df4e5-dba9-6030-e063-6394a90a76d3	2026-01-09	Warnings	Exact identifier application number: M020
Unseen Sunscreen Lip Protector SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	12605fb4-0de6-94f3-e063-6294a90a3a6f	2026-01-09	Warnings	Exact identifier application number: M020
Unseen Sunscreen Stick SPF 40	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	2735c5c7-a4ef-33c3-e063-6294a90abf97	2026-01-09	Warnings	Exact identifier application number: M020
PLAY Sunscreen SPF 50	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Supergoop LLC	2860d42c-d644-8b5a-e063-6394a90aec10	2026-01-09	Warnings	Exact identifier application number: M020
PLAY Mineral SPF 30 with Green Algae	ZINC OXIDE	Supergoop LLC	29a1ff4b-3875-5275-e063-6394a90a53fd	2026-01-09	Warnings	Exact identifier application number: M020
Every. Single. Face. Watery SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	d086a9b8-19e5-f713-e053-2995a90aa976	2026-01-09	Warnings	Exact identifier application number: M020
3D Tinted Moisturizing BS SPF 30	ZINC OXIDE	Allure Labs	47fd415f-819e-bbb8-e063-6394a90a2c6a	2026-01-09	Warnings	Exact identifier application number: M020
ST MORIZ SUNCARE BODY SUNSCREEN SPF50	SUNCARE BODY SUNSCREEN SPF50	Aopline Biotechnology (Guangzhou) Co., Ltd.	4801cfd2-1fe2-d118-e063-6294a90a6c8b	2026-01-09	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE
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
58892-348-45	58892034845	1 TUBE in 1 CARTON (58892-348-45) / 42.5 g in 1 TUBE	1 tube	2018-11-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DRUG FACTS	Fallien Cosmeceuticals, LTD \| Custom Analytics LLC \| Fragrance Manufacturing Inc. (FMI)	2025-01-09	HUMAN OTC DRUG LABEL	2