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 220 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Superactive Moisturizer SPF 50 Brightening SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Murad, LLC	4ff8525a-4526-4acf-86c7-88f1f1073274	2025-03-26	Warnings	Exact identifier application number: M020
Lip Balm SPF15 Unflavored	LIP BALM SPF15	LS Promotions Inc	3131632d-735c-6688-e063-6294a90a0239	2025-03-26	Warnings	Exact identifier application number: M020
Lip Balm SPF15 Chocolate Sundae flavored	LIP BALM SPF15	LS Promotions Inc	3142f352-ee65-47b5-e063-6394a90ada57	2025-03-26	Warnings	Exact identifier application number: M020
Lip Balm SPF15 Pina Colada flavored	LIP BALM SPF15 PINA COLADA FLAVORED	LS Promotions Inc	31440153-e7ca-1327-e063-6294a90a562c	2025-03-26	Warnings	Exact identifier application number: M020
CVS Health Sport 100 Clear	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS PHARMACY	0a245b1b-eaf6-7011-e063-6294a90ab68f	2025-03-26	Warnings	Exact identifier application number: M020
Lip Balm SPF15 Apple Pie flavored	LIP BALM SPF15 APPLE PIE FLAVORED	LS Promotions Inc	3145bd6d-0ece-e9d5-e063-6294a90afb9d	2025-03-26	Warnings	Exact identifier application number: M020
HEB Glow 40 Tinted Sunscreen Face Primer	AVOBENZONE, OCTISALATE, OCTOCRYLENE	H.E.B.	3146bcd9-d562-9ba6-e063-6294a90a37aa	2025-03-26	Warnings	Exact identifier application number: M020
HEB 50 Clear Mineral Clear Zinc Oxide Sunscreen	ZINC OXIDE	H.E.B.	3146fb5f-1fb5-f09f-e063-6294a90a6206	2025-03-26	Warnings	Exact identifier application number: M020
HEB 50 Glow Body Oil Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B.	31473cc9-08f5-39e3-e063-6294a90aa499	2025-03-26	Warnings	Exact identifier application number: M020
HEB 50 Clear Mineral Clear Zinc Oxide Sunscreen	ZINC OXIDE	H.E.B.	314776a8-a562-3dd2-e063-6394a90ab1b9	2025-03-26	Warnings	Exact identifier application number: M020
TRADER JOES INVISIBLE BODY SUNSCREEN SPF 40	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Trader Joe's Company	31478f5a-88f4-4b01-e063-6394a90a04b7	2025-03-26	Warnings	Exact identifier application number: M020
TRADER JOES SHIMMER SUNSCREEN BROAD SPECTRUM SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Trader Joe's Company	3147c08f-c3f2-aef1-e063-6294a90a5c44	2025-03-26	Warnings	Exact identifier application number: M020
HEB SPF 50 Mangonada Scented Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	3147ef18-9029-6d5b-e063-6394a90acee0	2025-03-26	Warnings	Exact identifier application number: M020
HEB SPF 50 Mexican Vanilla Scented Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	31487bad-a756-9050-e063-6394a90acacc	2025-03-26	Warnings	Exact identifier application number: M020
TRADER JOES DAILY FACIAL MINERAL SUNSCREEN SPF 40	ZINC OXIDE	Trader Joe's Company	3148c00f-21bb-c05f-e063-6394a90af0e8	2025-03-26	Warnings	Exact identifier application number: M020
HEB SPF 50 Chamomile and Lavender Scented Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	314b8147-fe7a-0698-e063-6394a90a872c	2025-03-26	Warnings	Exact identifier application number: M020
HEB SPF 50 Shine Sunscreen with Vitamin C Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	314bcf42-ca01-0fa5-e063-6294a90a5fc8	2025-03-26	Warnings	Exact identifier application number: M020
Superactive Moisturizer SPF 50 Hydrating SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Murad, LLC	1e5d494b-dccf-4ba1-89de-0bb4ba5b8d38	2025-03-26	Warnings	Exact identifier application number: M020
Superactive Moisturizer SPF 50 Wrinkle Fighting SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Murad, LLC	ac6163fb-dbc1-432f-a590-86d31c93b29b	2025-03-26	Warnings	Exact identifier application number: M020
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Deep FairLight Neutral Tan Rich Honey LightMedium and Neutral Medium	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	e17dc640-30e9-441b-a212-ef1508af7944	2025-03-25	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