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: 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	58892-348		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: 2027-12-31

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 270 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Banana Boat Ultra Sport Sunscreen Broad Spectrum SPF 15	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands, LLC	9751a700-5d51-357b-e053-2a95a90af66c	2024-10-27	Warnings	Exact identifier application number: M020
Banana Boat Sport Ultra Face SPF30	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	dc757b03-7e7d-b362-e053-2a95a90a8446	2024-10-27	Warnings	Exact identifier application number: M020
Banana Boat Kids Mineral Protection SPF50	TITANIUM DIOXIDE,ZINC OXIDE	Edgewell Personal Care Brands LLC	dc7701b5-0c73-b4df-e053-2a95a90a0f1b	2024-10-27	Warnings	Exact identifier application number: M020
Banana Boat Mineral Sensitive SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Edgewell Personal Care Brands LLC	dc7913d5-58f2-3077-e053-2a95a90a1627	2024-10-27	Warnings	Exact identifier application number: M020
BANANA BOAT PROTECTION PLUS VITAMINS SUNSCREEN UVA/UVB BORAD SPECTRUM SPF 30	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	e5f9d56d-a80e-221c-e053-2a95a90aae92	2024-10-27	Warnings	Exact identifier application number: M020
Banana Boat Mineral Sensitive Face SPF50	TITANIUM DIOXIDE, ZINC OXIDE	Edgewell Personal Care Brands LLC	dc783438-b28f-b7f4-e053-2a95a90a3d65	2024-10-27	Warnings	Exact identifier application number: M020
BANANA BOAT PROTECTION PLUS VITAMINS SUNSCREEN UVA/UVB BORAD SPECTRUM SPF 30	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	e53509bf-6bb7-2db7-e053-2a95a90aae18	2024-10-27	Warnings	Exact identifier application number: M020
Banana Boat Sport Mineral SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Edgewell Personal Care Brands LLC	dc79790f-e2bc-5414-e053-2a95a90a9e7a	2024-10-27	Warnings	Exact identifier application number: M020
TiZO Mineral Stick - Tinted SPF 45	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	fd6d0080-0bef-4e7e-8ca5-b859639efd0c	2024-10-25	Warnings	Exact identifier application number: M020
Alumier MD Post Procedure Kit with Hydrocortisone	TITANIUM DIOXIDE, ZINC OXIDE, HYDROCORTISONE	Alumier Labs	2551d748-c3d6-cd18-e063-6294a90adab6	2024-10-25	Warnings	Exact identifier application number: M020
TiZO Mineral Stick Non-Tinted SPF 45	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	e7044f18-992a-4f60-9a2b-f11ed06db09b	2024-10-25	Warnings	Exact identifier application number: M020
CoTZ Lip Balm	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	479a7d82-a068-4c2e-b50b-555c40e13e37	2024-10-25	Warnings	Exact identifier application number: M020
TiZO Mineral Sun Defense SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals Ltd.	e17a8c35-2d49-4c99-b154-ea673c14753e	2024-10-25	Warnings	Exact identifier application number: M020
IPKN Moist and Firm Beauty Balm Light Medium	TITANIUM DIOXIDE	Inel Cosmetics Co., Ltd.	1af6184e-3dc4-4eb3-8d51-aca724473451	2024-10-25	Warnings	Exact identifier application number: M020
IPKN Moist and Firm Beauty Balm Light	TITANIUM DIOXIDE	Inel Cosmetics Co., Ltd.	77d77838-aa13-4939-a1a0-50189fbb3fe0	2024-10-25	Warnings	Exact identifier application number: M020
Dove Men plus Care Hydrate Face	AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE	CONOPCO Inc. d/b/a Unilever	afe75aff-c056-eaf7-e053-2a95a90af71b	2024-10-24	Warnings	Exact identifier application number: M020
Cancer Council Mineral Fluid SPF50	ZINC OXIDE	Vitality US Co.	1638f8a4-a2da-4e1f-e063-6294a90a03d9	2024-10-24	Warnings	Exact identifier application number: M020
Marlowe SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Marlowe Holdings, LLC	f94bd91a-f0ab-680c-e053-6394a90ac855	2024-10-23	Warnings	Exact identifier application number: M020
Vacation Broad Spectrum SPF 30	HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	Vacation Inc.	2526eadf-4b55-ff81-e063-6394a90a3ba7	2024-10-23	Warnings	Exact identifier application number: M020
Tenacious Ergodyne	KREWD CLEAR SPF 50 CONTINUOUS SPRAY	Tenacious Holdings, Inc.	55d99d0a-dc7f-4915-b7c1-f999c8b36e0d	2024-10-23	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