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 335 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Broad Spectrum SPF 30 Sun Stick	BROAD SPECTRUM SPF 30 SUN STICK	Raining Rose, Inc	a35a7973-443b-5247-e053-2a95a90a4459	2023-10-23	Warnings	Exact identifier application number: M020
Cranberry Orange SPF 15 Broad Spectrum Lip Balm	CRANBERRY ORANGE SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a8c3aa41-c9a0-4f64-e053-2995a90a005e	2023-10-23	Warnings	Exact identifier application number: M020
Super Mint SPF 15 Broad Spectrum Lip Balm	SUPER MINT SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a9626a2f-9931-78d2-e053-2995a90ac40f	2023-10-23	Warnings	Exact identifier application number: M020
Spearmint SPF 30 Broad Spectrum Lip Balm	SPEARMINT SPF 30 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	b7b520dc-bae6-614f-e053-2995a90ae677	2023-10-23	Warnings	Exact identifier application number: M020
Citrus SPF 15 Broad Spectrum Lip Balm	CITRUS SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a75d0651-6001-29ce-e053-2a95a90a967f	2023-10-23	Warnings	Exact identifier application number: M020
Coconut Mineral SPF 15 Broad Spectrum Lip Balm	COCONUT MINERAL SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	b7b542fa-b0d2-7b33-e053-2995a90a7119	2023-10-23	Warnings	Exact identifier application number: M020
Vanilla SPF 30 Broad Spectrum Lip Balm	VANILLA SPF 30 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	b7b542fa-b0c2-7b33-e053-2995a90a7119	2023-10-23	Warnings	Exact identifier application number: M020
Pineapple Mineral SPF 15 Broad Spectrum Lip Balm	PINEAPPLE MINERAL SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	b7c6684f-1122-20c1-e053-2995a90ae6cf	2023-10-23	Warnings	Exact identifier application number: M020
Farmasi CC Cream LIGHT to MEDIUM 02	TITANIUM DIOXIDE	TAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI	28b3fdff-1986-4048-9ed5-a3d784a4014e	2023-10-23	Warnings	Exact identifier application number: M020
Farmasi CC Cream- MEDIUM 03	TITANIUM DIOXIDE	TAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI	65de3c45-8ec2-4d73-8a29-6203d3b47bd7	2023-10-23	Warnings	Exact identifier application number: M020
Farmasi BB Cream- MEDIUM 03	TITANIUM DIOXIDE	TAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI	9102aa2f-0308-4985-b8a8-8e105047b61f	2023-10-23	Warnings	Exact identifier application number: M020
Caribbean Breeze SPF 15 Broad Spectrum Lip Balm	CARIBBEAN BREEZE SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a75a42f6-27d1-e2cc-e053-2a95a90aa6da	2023-10-23	Warnings	Exact identifier application number: M020
Iced Pear SPF 15 Broad Spectrum Lip Balm	ICED PEAR SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a8c4a0ec-e07e-1cda-e053-2a95a90a0f3f	2023-10-23	Warnings	Exact identifier application number: M020
Lemonade SPF 15 Broad Spectrum Lip Balm	LEMONADE SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a8ffc32b-b758-0f8f-e053-2995a90adb62	2023-10-23	Warnings	Exact identifier application number: M020
Strawberry SPF 15 Broad Spectrum Lip Balm	STRAWBERRY SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a902d590-0726-ad6f-e053-2995a90a1130	2023-10-23	Warnings	Exact identifier application number: M020
Orange Creamsicle SPF 15 Broad Spectrum Lip Balm	ORANGE CREAMSICLE SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a9005cb1-ae1a-7736-e053-2995a90a28ea	2023-10-23	Warnings	Exact identifier application number: M020
Neora Age IQ Invisi-Bloc Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Neora, LLC	f2f3601f-081a-4bae-e053-2a95a90a4fac	2023-10-23	Warnings	Exact identifier application number: M020
Neora Age IQ Invisi-Bloc Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Neora, LLC	82f48635-1dc4-8c0d-e053-2991aa0a60cc	2023-10-23	Warnings	Exact identifier application number: M020
Artistry Exact Fit Longwearing Foundation Shade Golden L4N1	TITANIUM DIOXIDE	Amway Corp	7494fe09-40e0-4152-9974-a6e8a4d7f421	2023-10-22	Warnings	Exact identifier application number: M020
Artistry Exact Fit Longwearing Foundation Shade Soleil L3W1	TITANIUM DIOXIDE	Amway Corp	cec51b88-a6b8-4b64-b3aa-830e712a3c8a	2023-10-22	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