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 106 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 3CR	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	3894273d-c5e7-4ea8-9956-5ac3d88b7420	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 3C	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	8b63133c-150a-4290-a7fb-56b0dc42a8ce	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 3.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	ae7ca27f-7806-452e-9935-4a4abc37a5eb	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2WP	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	9bbacc16-8d60-4170-a3cb-0bfb748177a2	2025-12-19	Warnings	Exact identifier application number: M020
Perricone MD NEUROPEPTIDE Rejuvenating Moisturizer SPF 25 Broad Spectrum SPF 25	ZINC OXIDE	THG Beauty USA LLC	464e2d4e-9837-e6d5-e063-6294a90a726a	2025-12-19	Warnings	Exact identifier application number: M020
YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 FAIR	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	4327c775-e179-47d8-9b4b-945fc1b0b234	2025-12-19	Warnings	Exact identifier application number: M020
YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 LIGHT	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	0f3a9b6a-b1b2-4d69-88de-6f22c17a4844	2025-12-19	Warnings	Exact identifier application number: M020
YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 TAN	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	5cce7646-d9f5-454b-b7a8-a5a6b62a1916	2025-12-19	Warnings	Exact identifier application number: M020
YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 RICH	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	7da16dd7-c26c-4c4e-905f-3bbb878022cc	2025-12-19	Warnings	Exact identifier application number: M020
YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 MEDIUM-TAN	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	85f3dd47-4f1f-4fa3-a171-4f4b7707191c	2025-12-19	Warnings	Exact identifier application number: M020
YOUR SKIN BUT BETTER CC ILLUMINATION FAIR	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	4e5764f3-9d9e-460b-ab1e-36f280281dec	2025-12-19	Warnings	Exact identifier application number: M020
YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 MEDIUM	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	e700dc6e-e7ae-47ee-9974-430bfd045b4f	2025-12-19	Warnings	Exact identifier application number: M020
YOUR SKIN BUT BETTER CC ILLUMINATION MEDIUM-TAN	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	c7924d60-03fb-4a4d-b718-e324f6f1f65f	2025-12-19	Warnings	Exact identifier application number: M020
THE GOLDEN GUARD Browning Radiance Gel Suncare for Body	AVOBENZONE, OCTISALATE, AND OCTOCRYLENE	Dune Suncare, Inc.	4654c417-faa3-23c6-e063-6394a90a2b5a	2025-12-19	Warnings	Exact identifier application number: M020
THE MINERAL MELT Invisible Mineral Suncare for Face	TITANIUM DIOXIDE, ZINC OXIDE	Dune Suncare, Inc.	46557319-7546-e712-e063-6394a90a3cfe	2025-12-19	Warnings	Exact identifier application number: M020
Sand Cloud Mineral Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Sand Cloud Holdings, LLC	ff477199-9b01-fc90-e053-6294a90a5102	2025-12-19	Warnings	Exact identifier application number: M020
Sand Cloud Mineral Sunscreen For Face	TITANIUM DIOXIDE AND ZINC OXIDE	Sand Cloud Holdings, LLC	ff2346c6-d911-87b3-e053-6394a90ac6f8	2025-12-19	Warnings	Exact identifier application number: M020
Radiant Defense Perfecting Liquid Broad Spectrum SPF 30 - Shell	TITANIUM DIOXIDE, ZINC OXIDE	Rodan & Fields	12c63195-8707-4df0-a4d3-6f31c543db7a	2025-12-19	Warnings	Exact identifier application number: M020
EltaMD UV SPF35	OCTINOXATE, ZINC OXIDE SUNSCREEN	CP Skin Health Group, Inc	3029d6ed-a60b-4789-a567-d09b12d76bf4	2025-12-19	Warnings	Exact identifier application number: M020
OUHOE Universal Colored Moisturizer	TITANIUM DIOXIDE	Shantou Ouhoe Technology Co., Ltd.	4634fdcd-6f0e-25ca-e063-6294a90a196e	2025-12-18	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