CoTZ Lip Balm

Product NDC: 58892-124
11-digit product format: 588920124
Labeler code: 58892
Product ID: 58892-124_25534601-0cf8-2490-e063-6394a90a2f7c
Type: HUMAN OTC DRUG
Nonproprietary name: Titanium Dioxide, Zinc Oxide
Dosage form: STICK
Route: TOPICAL
Labeler: Fallien Cosmeceuticals, LTD
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-04-15
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 40; 55 mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 Lip Balm
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TITANIUM DIOXIDE	40 mg/g
ZINC OXIDE	55 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
479a7d82-a068-4c2e-b50b-555c40e13e37	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58892-124-45	CoTZ Lip Balm	1 in 1 CARTON	STICK	1		2
58892-124-45	CoTZ Lip Balm	4.5 g in 1 TUBE	STICK	4.5		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58892-124	COTZ LIP BALM (TITANIUM DIOXIDE, ZINC OXIDE) STICK [FALLIEN COSMECEUTICALS, LTD]	2	Current NDC, Legacy NDC, 2 package rows	20241114_479a7d82-a068-4c2e-b50b-555c40e13e37.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 253 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nu Skin 180 Degree UV Defense Hydrator SPF 18	OCTINOXATE AND ZINC OXIDE	NSE Products, Inc	91a22a5a-87fd-4db0-9183-caebee401304	2024-12-24	Warnings	Exact identifier application number: M020
Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 27 Sunscreen	OCTINOXATE AND TITANIUM DIOXIDE	L'Oreal USA Products Inc	aefd7884-6bc3-4b0b-ba36-1f3e8fe49f93	2024-12-23	Warnings	Exact identifier application number: M020
Attitude mineral sunscreen tropical SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	56e57ca0-d163-4580-9bca-747acce4d69f	2024-12-23	Warnings	Exact identifier application number: M020
(S)UNDERCOVER SPF 50	ZINC OXIDE	TUBBY TODD	dca478a0-c319-68d8-e053-2a95a90a10fc	2024-12-23	Warnings	Exact identifier application number: M020
LOreal Paris Revitalift Triple Power Anti Aging Moisturizer Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	LOreal USA Products Inc	e7bef1da-ea35-4306-b043-73d566a7e6bb	2024-12-23	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios UV Tone Broad Spectrum SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	46aa9917-52ac-4c57-afde-366d2d3ca200	2024-12-23	Warnings	Exact identifier application number: M020
La Roche Posay Anthelios UV Clear Daily Invisible Broad Spectrum SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	1d115945-fa1b-485b-bf53-44308fd1a630	2024-12-23	Warnings	Exact identifier application number: M020
Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 26 Sunscreen	OCTINOXATE	L'Oreal USA Products Inc	7cc920de-c91f-4040-a0b9-ea216d6f9bd7	2024-12-23	Warnings	Exact identifier application number: M020
Kids SPF50Plus Mineral Sunscreen Rollerball Totally Tropical	ZINC OXIDE AND TITANIUM DIOXIDE	KAS Direct LLC dba BabyGanics	d3bdda65-bcb4-42d9-84af-d14c7f4421bd	2024-12-23	Warnings	Exact identifier application number: M020
LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Broad Spectrum SPF 50 Sunscreen Skin Protectant	DIMETHICONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDE	LOreal USA Products Inc	e8539a43-db85-451c-bce8-2c488f3dc40d	2024-12-23	Warnings	Exact identifier application number: M020
NYX Professional Makeup Buttermelt Glaze SOFT GLOW SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30	HOMOSALATE,OCTISALATE AND OCTOCRYLENE	LOreal USA Products Inc	81093d80-dcaf-4555-98b2-48ce7eb84d0c	2024-12-23	Warnings	Exact identifier application number: M020
Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 26 Sunscreen	OCTINOXATE	SICOS ET CIE	c634eaab-f014-4155-a40b-9030e358ec12	2024-12-23	Warnings	Exact identifier application number: M020
Kids SPF50 Plus Mineral Sunscreen Continuous Totally Tropical	ZINC OXIDE AND TITANIUM DIOXIDE	KAS Direct LLC dba BabyGanics	d5ffe993-de8f-4623-a010-9cb8dd70de07	2024-12-23	Warnings	Exact identifier application number: M020
CERAVE Hydrating Mineral Sunscreen Light Sheer Tint Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	LOreal USA Products Inc	8b298516-70df-47ab-834f-51dcde28a43a	2024-12-23	Warnings	Exact identifier application number: M020
Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 27 Sunscreen	OCTINOXATE AND TITANIUM DIOXIDE	SICOS ET CIE	6a14ee23-28c9-4704-8af9-d1c4db0d9256	2024-12-23	Warnings	Exact identifier application number: M020
Walgreens SPF 50 Hydrating	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	f347588d-8225-45a7-e053-2995a90ab688	2024-12-22	Warnings	Exact identifier application number: M020
Mineral Sunstick	ZINC SPF STICK	Tubby Todd	29e41fe8-4e17-dbaa-e063-6294a90a4a10	2024-12-22	Warnings	Exact identifier application number: M020
Mineral Sunscreen	ZINC OXIDE SPF 50	Tubby Todd	29e487da-5312-8192-e063-6294a90ad809	2024-12-22	Warnings	Exact identifier application number: M020
EcoStick Sunscreen SPF 35	ZINC OXIDE, TITANIUM DIOXIDE	Stream2Sea, LLC	eba17b7a-5e96-4462-9b71-44c2bc577dce	2024-12-21	Warnings	Exact identifier application number: M020
Planet Protecting Sunscreen 30	TITANIUM DIOXIDE	Stream2Sea, LLC	89e44c5f-121e-4fdd-b9e0-023909ea32f5	2024-12-21	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
58892-124-45	58892012445	1 TUBE in 1 CARTON (58892-124-45) / 4.5 g in 1 TUBE	1 tube	2021-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CoTZ Lip Balm - Fallien Cosmeceuticals, LTD \| Custom Analytics LLC \| Fragrance Manufacturing Inc. (FMI)	Fallien Cosmeceuticals, LTD \| Custom Analytics LLC \| Fragrance Manufacturing Inc. (FMI)	2024-10-25	HUMAN OTC DRUG LABEL	2