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 261 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MISSHA M Perfect Cover BB Cream SPF42 (No. 25)	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE	Able C&C Co., Ltd.	604e7a49-7986-11ee-e053-2a91aa0a1bee	2024-12-05	Warnings	Exact identifier application number: M020
MISSHA M Perfect Cover BB No 27	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE	Able C&C Co., Ltd.	c4e16cec-c7db-4e5e-9d05-5d7afdb79091	2024-12-05	Warnings	Exact identifier application number: M020
MISSHA M Perfect Cover BB SPF42 No29	OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE	Able C&C Co., Ltd.	3fc90114-4cdf-273e-e054-00144ff8d46c	2024-12-05	Warnings	Exact identifier application number: M020
MISSHA M Perfect Cover BB No 31	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE	Able C&C Co., Ltd.	95862d15-d977-7276-e053-2995a90ab690	2024-12-05	Warnings	Exact identifier application number: M020
MISSHA M Perfect Cover BB Cream SPF42 No. 25	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE	Able C&C Co., Ltd.	9c6f48b1-007b-434f-b756-242e3390e9b7	2024-12-05	Warnings	Exact identifier application number: M020
MISSHA ALL AROUND VITA C SUNSCREEN	ZINC OXIDE, HOMOSALATE, ETHYLHEXYL SALICYLATE, TITANIUM DIOXIDE	Able C&C Co., Ltd.	1a7ec673-328a-8924-e063-6294a90a2f3d	2024-12-05	Warnings	Exact identifier application number: M020
(Re)Setting Refreshing Mist SPF 40	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	d4d8f28d-cb00-298d-e053-2995a90a10eb	2024-12-05	Warnings	Exact identifier application number: M020
KEYS SOULCARE DAILY MOISTURIZER BROAD SPECTRUM SPF30 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc	2ba71f81-54d0-4955-9bae-2b6e35c9c35f	2024-12-05	Warnings	Exact identifier application number: M020
Cay Skin Isle Glow Body SPF 45	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Cay Skin, Inc.	db5f6bad-65ae-2b05-e053-2a95a90a8569	2024-12-05	Warnings	Exact identifier application number: M020
Cay Skin Isle Glow Face SPF 45	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Cay Skin, Inc.	d91bba06-fd9b-3eb5-e053-2995a90a6124	2024-12-05	Warnings	Exact identifier application number: M020
Whoa Glow broad spectrum spf 30 sunscreen Sheer Bronze shimmer	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc	65de9491-8804-4e3b-90a7-9b253e34b7d3	2024-12-05	Warnings	Exact identifier application number: M020
Whoa Glow broad spectrum spf 30 sunscreen Sheer Champagne shimmer sunlight	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc	499e5352-fcc4-4434-96f2-4375816991c9	2024-12-05	Warnings	Exact identifier application number: M020
Cay Skin Isle Sheen Sunstick SPF 35	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cay Skin, Inc.	288c3aeb-01b2-ce39-e063-6394a90ad04a	2024-12-05	Warnings	Exact identifier application number: M020
Cay Skin MoBay Mineral Sunscreen Drops SPF 30	ZINC OXIDE	Cay Skin, Inc.	288d5456-98f3-a998-e063-6294a90a8366	2024-12-05	Warnings	Exact identifier application number: M020
Solar Moisturizer SPF 30	OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE	Allure Labs, LLC	ef4d54bf-25f5-4261-9d3d-c42b0d892275	2024-12-05	Warnings	Exact identifier application number: M020
Clear Clear Zinc Solar Protection SPF 30	ZINC OXIDE	Allure Labs, LLC	79a3c8e2-c4f2-4c00-8e94-494654ae91a2	2024-12-05	Warnings	Exact identifier application number: M020
LAB SERIES DAY RESCUE DEFENSE BROAD SPECTRUM SPF 35	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OXYBENZONE	Aramis Inc.	8b206b6d-92e4-48bc-a40c-93ffdd635535	2024-12-05	Warnings	Exact identifier application number: M020
Kids Broad Spectrum SPF 35	ZINC OXIDE	Allure Labs, LLC	b72caf9b-46df-f30c-e053-2995a90a9b6d	2024-12-05	Warnings	Exact identifier application number: M020
CBD Blue Light Defense SPF 30	ZINC OXIDE	Allure Labs	b63b99af-2ddb-3535-e053-2a95a90a65d5	2024-12-05	Warnings	Exact identifier application number: M020
AHAVA CC SPF 30	AVOBENZONE, ENSULIZOLE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	AHAVA - Dead Sea Laboratories Ltd	2fa6249a-9614-455c-8e07-9b829f3b0c22	2024-12-04	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