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 236 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Black Girl Sunscreen SPF 50 broad Spectrum	AVOBENZONE, HOMOSALATE, OCTISALATE	Black Girl Sunscreen, LLC	2bc471f0-c93e-0c51-e063-6394a90a77f0	2025-01-15	Warnings	Exact identifier application number: M020
Black Girl Sunscreen SPF 45	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Black Girl Sunscreen, LLC	2bc4b1b1-5f19-7ba3-e063-6394a90a5de7	2025-01-15	Warnings	Exact identifier application number: M020
Black Girl Sunscreen Sunscreen SPF 30 broad Spectrum	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Black Girl Sunscreen, LLC	2bc4c639-787a-d2d3-e063-6394a90a5ded	2025-01-15	Warnings	Exact identifier application number: M020
Black Girl Sunscreen Sunscreen SPF 30 broad Spectrum	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Black Girl Sunscreen, LLC	2bc4d937-77d0-273c-e063-6394a90a25e7	2025-01-15	Warnings	Exact identifier application number: M020
Black Girl Sunscreen Sunscreen SPF 30 broad Spectrum	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Black Girl Sunscreen, LLC	2bc4cfd9-e44c-9b93-e063-6394a90a96a6	2025-01-15	Warnings	Exact identifier application number: M020
Black Girl Sunscreen Sunscreen SPF 30 broad Spectrum	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Black Girl Sunscreen, LLC	2bc4e22d-6265-9c0b-e063-6394a90a1541	2025-01-15	Warnings	Exact identifier application number: M020
Black Girl Sunscreen Sunscreen SPF 30 broad Spectrum	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Black Girl Sunscreen, LLC	2bc4eb32-8c0b-32fc-e063-6294a90a1625	2025-01-15	Warnings	Exact identifier application number: M020
Black Girl Sunscreen Sunscreen SPF 30 broad Spectrum	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Black Girl Sunscreen, LLC	2bc50182-30f2-b77e-e063-6394a90a6355	2025-01-15	Warnings	Exact identifier application number: M020
Black Girl Sunscreen Sunscreen SPF 30 broad Spectrum	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Black Girl Sunscreen, LLC	2bc50182-30f5-b77e-e063-6394a90a6355	2025-01-15	Warnings	Exact identifier application number: M020
MEDIFORDEAR CICA CALMING SUNSCREEN	HOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, AVOBENZONE	Youngwon Costech Co.,ltd.	2bc94923-b221-5159-e063-6394a90ab8ff	2025-01-15	Warnings	Exact identifier application number: M020
Meaningful Beauty Cindy Crawford Anti-Aging Day Creme with Environmental Protection Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OXYBENZONE	Meaningful Beauty, LLC	6423e1c7-85cd-46f8-8fc9-a7284e3577d1	2025-01-15	Warnings	Exact identifier application number: M020
Stay AgelessTinted Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	Spectrum Aesthetics Laser Training LLC	026b9b30-ef08-bf2e-e063-6394a90a54a6	2025-01-14	Warnings	Exact identifier application number: M020
Daily Sunscreen Broad Spectrum SPF 30 UVA UVB	MINERAL SUNSCREEN SPF 30	IHerb, LLC	2d8101ef-96a3-1463-e063-6294a90add4d	2025-01-14	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Tinted Mineral Sunscreen Face Stick Unscented SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0d85b0a1-3705-2829-e063-6394a90a0ed7	2025-01-13	Warnings	Exact identifier application number: M020
Attitude mineral sunscreen orange blossom SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0b85ea68-6113-4e92-a10a-39d13099d12d	2025-01-13	Warnings	Exact identifier application number: M020
Skinfuse Shield SPF 30	ZINC OXIDE	Owen Biosciences, Inc.	02d46d44-2476-4f96-9c72-783c392317de	2025-01-13		Exact identifier application number: M020
Chem Free SPF 30	ZINC OXIDE	Owen Biosciences, Inc.	7e5930fe-eb0f-4a21-8065-8831dd5b351c	2025-01-13	Warnings	Exact identifier application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 Shell	ZINC OXIDE	EVER FAME PTE. LTD.	2b9b5a73-858e-78dd-e063-6394a90ad082	2025-01-13	Warnings	Exact identifier application number: M020
Tula Skincare protect and go dewy glow sunscreen stick broad spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	2b9acb63-b32c-336c-e063-6394a90a4a9c	2025-01-13	Warnings	Exact identifier application number: M020
Brush and Go All Skin types	TITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONE	Noon Aesthetics M.R. Ltd	9ee5b3c2-4369-4c4b-ab55-b52661b82188	2025-01-13	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