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 238 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
glo SKIN BEAUTY Moisturizing Tint SPF 30	GLO SKIN BEAUTY MOISTURIZING TINT SPF 30	Hayden Caleel LLC	2b464a70-8f40-3148-e063-6394a90ac18c	2025-01-09	Warnings	Exact identifier application number: M020
Sunscreen and insect repellent Bull frog	SPF 50	Bullfrog Brands, LLC	d65d15a6-0a32-1203-e053-2995a90aa6c5	2025-01-09	Warnings	Exact identifier application number: M020
Sunscreen and insect repellent Bull frog	SPF 50	Bullfrog Brands, LLC	d5fb3632-24da-2c7a-e053-2a95a90a5081	2025-01-09	Warnings	Exact identifier application number: M020
Protect Tinted Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	NEW SEASON DERMATOLOGY, PLLC	fecd72a3-c7e5-3dfa-e053-6394a90a7357	2025-01-09	Warnings	Exact identifier application number: M020
ERBORIAN DOUBLE SAMPLE CC CREME CLAIR and DORE SPF 25	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	41b3cf18-dc11-4e1d-802e-5ba25bd87adb	2025-01-09	Warnings	Exact identifier application number: M020
ECLIPSE SPF 50 PERFECTINT BEIGE	TITANIUM DIOXIDE, ZINC OXIDE	SCIENCE OF SKINCARE LLC	b69dda25-372f-15d9-e053-2995a90a8d3e	2025-01-09	Warnings	Exact identifier application number: M020
PerfecTint Powder SPF 40 All Shades	ZINC OXIDE	Science of Skincare	bb26c010-299e-3dc5-e053-2995a90a2c89	2025-01-09	Warnings	Exact identifier application number: M020
Extreme Protect SPF 40 All Shades	ZINC OXIDE, TITANIUM DIOXIDE	Science of Skincare, LLC.	b69db78b-5f0e-8ca2-e053-2a95a90ac88c	2025-01-09	Warnings	Exact identifier application number: M020
ECLIPSE SPF 50 ALL SHADES	TITANIUM DIOXIDE, ZINC OXIDE	SCIENCE OF SKINCARE LLC	49df51e6-be9a-41be-b3e1-bfc062aaceaa	2025-01-09	Warnings	Exact identifier application number: M020
CoTZ Mineral Suns Stick - Tinted SPF 45	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	44a6ff9b-8067-4f32-acb2-4ede54c79e6e	2025-01-09	Warnings	Exact identifier application number: M020
NUDESCREEN BLUSH TINT SPF 30 - SUNKISSED	ZINC OXIDE SUNSCREEN	Bentley Laboratories, LLC	c45b59d8-0196-4dce-bfaa-57c47f655fe8	2025-01-09	Warnings	Exact identifier application number: M020
TiZO Tinted Lip Protection SPF 45	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	81ee1b28-c7d7-4b34-b0f0-5a3cc7a139a2	2025-01-09	Warnings	Exact identifier application number: M020
CoTZ Face Prime and Protect SPF 40 (Tinted)	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	1088fbf6-5790-490d-b272-ec281b4b76fa	2025-01-09	Warnings	Exact identifier application number: M020
CoTZ Face Prime and Protect SPF 40 (Non-Tinted)	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	f106f52b-2157-46c7-9f7c-50f43a649050	2025-01-09	Warnings	Exact identifier application number: M020
NUDESCREEN BLUSH TINT SPF 30 - SUNNY SWEET CHEEKS	ZINC OXIDE SUNSCREEN	Bentley Laboratories, LLC	5c98bacb-8bbd-47b8-8987-50be1ed34fc0	2025-01-09	Warnings	Exact identifier application number: M020
CoTZ Face Moisture	ZINC OXIDE	Fallien Cosmeceuticals, LTD	db682516-6c8f-4009-a9ec-e21dfc64ce15	2025-01-09	Warnings	Exact identifier application number: M020
L Bri CC DD Color Correcting Daily Defense Sunscreen SPF 30 Light Medium	OCTOCRYLENE, ZINC OXIDE	L'BRI Health & Beauty	bcd22c9a-2db6-4653-9ab5-825f3f5cc420	2025-01-08	Warnings	Exact identifier application number: M020
L Bri CC DD Color Correcting Daily Defense Sunscreen SPF 30 Light	OCTOCRYLENE, ZINC OXIDE	L'BRI Health & Beauty	c66c2a54-97c8-4904-a44a-b3cf790837f5	2025-01-08	Warnings	Exact identifier application number: M020
Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Tempo Industries, Inc.	af9aa56d-2f8a-55b9-e053-2a95a90a3258	2025-01-08	Warnings	Exact identifier application number: M020
Baby Mineral Sunscreen Probiotics SPF55	ZINC OXIDE	Hello Bello	0191b2e4-bcc5-541a-e063-6294a90a0e78	2025-01-08	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