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 239 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kids Face and Body Sunscreen SPF 50	ZINC OXIDE	Hello Bello	01cc4ea0-e3de-32f1-e063-6394a90a1375	2025-01-08	Warnings	Exact identifier application number: M020
Baby Mineral Sunscreen SPF55	ZINC OXIDE	Hello Bello	0190eeaf-c5a0-3253-e063-6294a90a43c4	2025-01-08	Warnings	Exact identifier application number: M020
Mineral Sunscreen SPF 50	ZINC OXIDE	Hello Bello	01cc205b-a345-262a-e063-6394a90a955c	2025-01-08	Warnings	Exact identifier application number: M020
Eco Lips Zinc SPF 30 Broad Spectrum Sunscreen Unscented	ZINC OXIDE	Eco Lips, Inc.	febabad6-0bf2-a3f8-e053-6294a90a3aeb	2025-01-08	Warnings	Exact identifier application number: M020
LESS EVERY TONE SPF 30	ZINC OXIDE	Happy Farm Botanicals, Inc.	e91ded4b-987d-17a8-e053-2995a90adc2e	2025-01-08	Warnings	Exact identifier application number: M020
Stay AgelessTinted Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	ETHEREAL AESTHETICS LLC	065d17cf-bea5-137f-e063-6394a90aeeb3	2025-01-08	Warnings	Exact identifier application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	SERRAO, E JOHN MD FACOG	fea61544-6684-ad34-e053-6294a90a48f3	2025-01-08	Warnings	Exact identifier application number: M020
Tinted Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	New Beginnings Tattoo Removal	fea87de3-116f-4774-e053-6394a90a0aad	2025-01-08	Warnings	Exact identifier application number: M020
Stay AgelessTinted Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	PURA VIDA BODY & MIND SPA, INC.	04b38e97-c4b3-df23-e063-6394a90ae6b7	2025-01-08	Warnings	Exact identifier application number: M020
EVEN DEFENSE Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	Premier Plastic Surgery	bc9221fe-89b4-4ad8-e053-2995a90aa041	2025-01-08	Warnings	Exact identifier application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	Emerald Aesthetics LLC	f80f439d-f4f0-fbf3-e053-6294a90ae0ef	2025-01-08	Warnings	Exact identifier application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	Suzanne's Skin2soul LLC	fea667a1-6bec-9819-e053-6394a90a9b96	2025-01-08	Warnings	Exact identifier application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	BEAUTY SENSE MEDSPA INC	fe93a337-8d2f-35d3-e053-6294a90acb3c	2025-01-08	Warnings	Exact identifier application number: M020
Sunscreen Emulsion SPF50plus	OCTOCRYLENE,ETHYLHEXYL METHOXYCIRNNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATE	Guangzhou Senmai Biotechnology Co.	1d560670-026b-bd34-e063-6394a90a9af4	2025-01-08	Warnings	Exact identifier application number: M020
Allies of Skin Sunless Tan SPF 50 Daily Self Tanner	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	ALLIES GROUP PTE. LTD.	4d58de8e-875b-4b77-b0ef-b9d760aaced8	2025-01-07	Warnings	Exact identifier application number: M020
Pop Zinc Sunscreen	ZINC OXIDE	Guangzhou Haishi Biological Technology Co., Ltd	2b29ddb2-5730-8a67-e063-6394a90ae416	2025-01-07	Warnings	Exact identifier application number: M020
COOLA Anti-Aging Sun Silk Drops Sunscreen SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE SUNSCREEN SERUM	COOLA LLC	bbb29d0c-ae1f-409e-8fd6-ff3ea34dc9c2	2025-01-07	Warnings	Exact identifier application number: M020
Advanced Day Ultimate Protect Sunscreen SPF 50	BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE	Medik8 Limited	29071920-ba90-871a-e063-6294a90aee27	2025-01-06	Warnings	Exact identifier application number: M020
Dimples Bath Co - Sunstick New Kid On The Block	ZINC OXIDE	Dimples Bath Co. LLC	26f682f4-2440-f111-e063-6294a90ab4b7	2025-01-06	Warnings	Exact identifier application number: M020
Diaper Rash Cream Happy Cheeks	DIAPER RASH HAPPY CHEEKS	Dimples Bath Co. LLC	26cef2eb-a133-11ec-e063-6394a90a0f08	2025-01-06	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