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 272 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
e.l.f. Holy Hydration Face Cream SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc	b7898d65-df86-580a-e053-2a95a90a5b1b	2024-11-06	Warnings	Exact identifier application number: M020
Bondi Sands Fragrance Free SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	BONDI SANDS (USA) INC.	acda604c-27cf-d500-e053-2995a90a5d65	2024-11-06	Warnings	Exact identifier application number: M020
Bondi Sands Fragrance Free SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	BONDI SANDS (USA) INC.	acb92160-1749-d51b-e053-2995a90a9e87	2024-11-06	Warnings	Exact identifier application number: M020
Bondi Sands Toasted Coconut Lip Balm with SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	BONDI SANDS (USA) INC.	acb8513e-723b-b7d6-e053-2995a90aed52	2024-11-06	Warnings	Exact identifier application number: M020
Bondi Sands Fragrance Free Face SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	BONDI SANDS (USA) INC.	acda9863-ad9f-e430-e053-2995a90a69a6	2024-11-06	Warnings	Exact identifier application number: M020
Birch Juice Moisturizing UVLOCK Sunstick SPF 50 Broad Spectrum	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	SEORIN COMPANY Co., Ltd.	26442417-f238-1fc3-e063-6394a90a6f82	2024-11-06	Warnings	Exact identifier application number: M020
Avene Mineral Sunscreen Face and Body	ZINC OXIDE	Pierre Fabre USA Inc.	fb5b1e94-bed3-8486-e053-6294a90a3a84	2024-11-06	Warnings	Exact identifier application number: M020
Avene Cleanance Mattifying SPF 30	ZINC OXIDE	Pierre Fabre USA Inc.	2644f545-0625-7858-e063-6394a90a5963	2024-11-06	Warnings	Exact identifier application number: M020
SPF30 CALENDULA SUNSCREEN	TITANIUM DIOXIDE	ORGANIC & SUSTAINABLE BEAUTY	64580be7-868c-40fb-b7b8-840b417b25d3	2024-11-06	Warnings	Exact identifier application number: M020
KIDS SPF30 SUPER SENSITIVE PLUS C111 SUNSCREEN	TITANIUM DIOXIDE	ORGANIC & SUSTAINABLE BEAUTY	20ebe264-2f79-4eef-b83d-3f09a3ca2898	2024-11-06	Warnings	Exact identifier application number: M020
Cream Oil Sunscreen	ZINC OXIDE, TITANIUM DIOXIDE SUNSCREEN	Owen Biosciences, Inc.	b2ccdfea-1c27-42af-b9d8-752e9f91ae87	2024-11-05	Warnings	Exact identifier application number: M020
Vivant Day Treatment SPF 15	OCTINOXATE 7.50% OCTISALATE 5.00%	Vivant Pharmaceuticals, LLC	10a95d0a-366f-0611-e063-6294a90abb44	2024-11-05	Warnings	Exact identifier application number: M020
ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	ZO Skin Health, Inc.	1560a6b6-8d4a-6942-e063-6294a90a4a44	2024-11-04	Warnings	Exact identifier application number: M020
Bali Body Watermelon Tanning Oil SPF 15	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Bali Body Pty Ltd	07d96576-fd78-acf3-e063-6394a90af45b	2024-11-03	Warnings	Exact identifier application number: M020
Neutrogena Mineral Ultra Sheer Dry-Touch Face and Body Sunscreen Broad Spectrum UVA-UVB SPF 50	ZINC OXIDE	Kenvue Brands LLC	8f34c1f6-51fe-4719-ba1f-1e23c05e937b	2024-11-01	Warnings	Exact identifier application number: M020
Hawaiian Tropic Mineral Skin Nourishing Milk Sunscreen Broad Spectrum SPF 30	ZINC OXIDE	Edgewell Personal Care Brands LLC	c8d6c731-2dfc-71c0-e053-2a95a90aa5b8	2024-11-01	Warnings	Exact identifier application number: M020
Hawaiian Tropic Sport Sunscreen Everyday Active	AVOBENZONE,HOMOSALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	dc64918f-df4c-3a5e-e053-2995a90aea4b	2024-11-01	Warnings	Exact identifier application number: M020
Byoma Moisturizing Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE	BYOMA LIMITED	25de7939-3b18-7f9e-e063-6394a90a23a9	2024-11-01	Warnings	Exact identifier application number: M020
ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	ZO Skin Health, Inc.	cda67d41-d063-4936-a6b9-23376304eb42	2024-11-01	Warnings	Exact identifier application number: M020
Dr Edward Krulig New Melan Sunblock SPF 50	AVOBENZONE, OCTISALATE, OCTOCRYLENE	KRULIG INTERNATIONAL, INC	21c301d2-b283-40e1-bf26-b4bdde278247	2024-10-31	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