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 69 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ALOE KOTE SPF 25	OCTINOXATE, OXYBENZONE, HOMOSALATE	Aloe Care International, LLC	12e78c53-ba19-4c8e-bd2f-8c85fccbc179	2026-01-26	Warnings	Exact identifier application number: M020
ALOE UP KIDS SPORT SUNSCREEN SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Aloe Care International, LLC	62016e94-b5d2-4ba2-ab9c-b0b2c1ead650	2026-01-26	Warnings	Exact identifier application number: M020
Homosalate 10 Avobenzone 3% Octocrylene 6%	SPF 45 FACE	S&C Hampton Sun LLC	e49808c9-5025-4965-8679-7fe824cf6907	2026-01-26	Warnings	Exact identifier application number: M020
ENVIRONMENTAL DEFENSE	ZINC OXIDE	Avasol LLC	1fbddab4-71f7-4167-ad21-30040b7c71bb	2026-01-26	Warnings	Exact identifier application number: M020
Surfers Barrier	ZINC OXIDE	Avasol LLC	d6e2ac0a-3bf6-4d08-8647-6a23de2ac857	2026-01-26	Warnings	Exact identifier application number: M020
SURFERS BARRIER SPF 50	ZINC OXIDE, TITANIUM DIOXIDE	Avasol LLC	ec55eef0-17e6-416d-bd5e-548f2f323cea	2026-01-26	Warnings	Exact identifier application number: M020
Zenskin Watery Dew Nia-Cica Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE SUNSCREEN	Zenskin Co. Ltd.	49584899-d523-9677-e063-6394a90a1403	2026-01-26	Warnings	Exact identifier application number: M020
Caring mill sun serum with Vitamin C Niacinamide	HOMOSALATE OCTOCRYLENE OCTISALATE AVOBENZONE	FSA Store lnc.	4931ee71-1088-1ac1-e063-6294a90ad82b	2026-01-25	Warnings	Exact identifier application number: M020
Caring mill Mineral Eye Cream	ZINC OXIDE	FSA STORE INC.	4932ea19-28cc-b245-e063-6394a90ac7aa	2026-01-25	Warnings	Exact identifier application number: M020
Ceile SPF 30 prime PROTECT Broad Spectrum SPF 30 Sunscreen	SUNSCREEN 30 MINERAL	LE COSMETICS INC	2cee0413-d532-c192-e063-6294a90aa823	2026-01-25	Warnings	Exact identifier application number: M020
BeginS by JUNGSAEMMOOL Blue Chamomile Hyaluronic Acid Aqua Sunscreen Broad Spectrum SPF 50 plus	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Jungsaemmool Beauty Co., Ltd.	62e23503-7233-434a-91f0-092f10d2717d	2026-01-24	Warnings	Exact identifier application number: M020
BeginS by JUNGSAEMMOOL Blue Chamomile Hyaluronic Acid Airy Sun Stick Broad Spectrum SPF 50 plus	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Jungsaemmool Beauty Co., Ltd.	030a20fb-4846-4a5c-9808-a399aac2ff0b	2026-01-24	Warnings	Exact identifier application number: M020
Mimosa Lane SPF45	OCTINOXATE, OCTISALATE, ZINC OXIDE SUNSCREEN	R&G Divergency LLC	40f3b8ea-bfa5-4c66-9c79-c4408bda857a	2026-01-24	Warnings	Exact identifier application number: M020
111 SKIN SUNSCREEN SPF 50	ZINC OXIDE	Bentley Laboratories, LLC	b1265797-71dd-4302-ab26-dbff6ccec856	2026-01-23	Warnings	Exact identifier application number: M020
Mania Holic Sunscreen Pack	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	Firstmarket Co., ltd.	b95a460c-1f7b-4193-b305-466e073af640	2026-01-23	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 320	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	1cdbae71-441b-426d-99ee-c889d76af452	2026-01-23	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 250	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	8f4b5e0a-4578-4af3-b7d9-a19d4eb732e7	2026-01-23	Warnings	Exact identifier application number: M020
ISA KNOX 365 BB SUNSCREEN Broad Spectrum SPF 40, PA	TITANIUM DIOXIDE	LG Household and Healthcare, Inc.	65e70306-9e79-494d-9217-a43002f16307	2026-01-23	Warnings	Exact identifier application number: M020
O HUI Sun Science Ideal Cover Sunscreen Broad Spectrum	TITANIUM DIOXIDE	LG Household and Healthcare, Inc.	c15ffd23-271d-458d-9048-9bc50331d5d7	2026-01-23	Warnings	Exact identifier application number: M020
Aqua protection Sunscreen Broad Spectrum SPF50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	ENGLEWOOD LAB, INC.	627e6ea5-016b-4ab6-a50c-aa9c27e5cca1	2026-01-23	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