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 209 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Proven Personalized Day Moisturizer Sunscreen SPF 30	ZINC OXIDE	Proven Skincare	5275d2c5-96e8-424d-a3c8-feea778191e4	2025-06-20	Warnings	Exact identifier application number: M020
LBEL CONCENTRE BASE SERUM ANTIEDAD EFECTO LIFTING FPS 15 ANTI AGING LIFTING SERUM FOUNDATION SPF 15 CHAMPAGNE 170-N	OCTINOXATE, ZINC OXIDE	BEL STAR SA	f9266687-73d2-dac9-e053-6394a90ac2a1	2025-06-20	Warnings	Exact identifier application number: M020
LBEL DEFENSE TOTAL SUNSCREEN FOR FACE AND BODY SPF 50	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	BEL STAR SA	fd0465aa-df1e-ce1c-e053-6294a90a2302	2025-06-20	Warnings	Exact identifier application number: M020
FEIBTH TALLOW SUNSCREEN	TALLOW SUNSCREEN	Guangzhou Qiexiran Cosmetics Co., Ltd.	37ead2b1-12d4-af92-e063-6394a90af0d6	2025-06-19	Warnings	Exact identifier application number: M020
LipBOMB	TITANIUM DIOXIDE, ZINC OXIDE	FLEUR DE VIE LLC	37ef4c1e-2183-a277-e063-6394a90ae2df	2025-06-19		Exact identifier application number: M020
Bioresist reinforcing effect face moisturizer SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	BEL STAR S A	99d7525d-b636-7f8e-e053-2a95a90a2080	2025-06-19	Warnings	Exact identifier application number: M020
Ultra Balm Moisturizing Protective Balm for lips SPF 20 Nude Translucide	OCTINOXATE, ZINC OXIDE	BEL STAR S A	c4d56723-3953-fb8e-e053-2a95a90a69d3	2025-06-19	Warnings	Exact identifier application number: M020
SPF 50 Daily UV Defense Broad Spectrum Sunscreen	OCTINOXATE, ZINC OXIDE	Vi Medical Products, INC	2d814f8a-23b5-209f-e063-6394a90a5091	2025-06-19	Warnings	Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	ESTHETICS BY RIKI LLC	37f2c5ed-c2f5-e569-e063-6294a90a15b1	2025-06-19		Exact identifier application number: M020
Ultra Balm Moisturizing Protective Balm for lips SPF 20 Nude Caramel	OCTINOXATE, ZINC OXIDE	BEL STAR S A	c4f95c1b-acbe-4bb7-e053-2995a90a9120	2025-06-19	Warnings	Exact identifier application number: M020
LBEL NUDE SKIN ULTRA LIGHT MATTE FOUNDATION WITH VITAMINS SPF 20 ALMENDRA 230-N	OCTINOXATE, ZINC OXIDE	Bel Star S.A.	d22fde8a-ba14-2cc7-e053-2a95a90a0e53	2025-06-19	Warnings	Exact identifier application number: M020
Correct and Protect Serum Broad Spectrum SPF 45	ZINC OXIDE	Murad, LLC	dba6e01b-a8ec-4812-bbe0-e418bb067032	2025-06-19	Warnings	Exact identifier application number: M020
Truffoire Truffle Brightening	OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONE	Innovation Brands Inc.	e3068ecf-0bee-4e8a-a439-4bb707a2845d	2025-06-18	Warnings	Exact identifier application number: M020
Aveeno Kids Continuous Protection Sensitive Skin Mineral Sunscreen Broad Spectrum SPF 50	ZINC OXIDE	Kenvue Brands LLC	383de98b-65b5-4398-a876-87367dc01d0b	2025-06-18	Warnings	Exact identifier application number: M020
CB Multi-Active Moisturizer with SPF 30	OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONE	Innovation Brands Inc.	d9557a6c-78e9-4b01-8a4b-e0eceb511c4e	2025-06-18	Warnings	Exact identifier application number: M020
1000 Roses CC Color plus Correct Sheer Beige SPF 30	ZINC OXIDE	Andalou naturals	2e7f3570-f710-41dd-95a0-7c0613b317a2	2025-06-17	Warnings	Exact identifier application number: M020
Skin by Scottie Beach Mode Mineral Sunscreen Roll-On SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	SKIN CARE BY SCOTTIE LLC	a9afa58c-f438-48c6-bd30-eda41334df74	2025-06-16	Warnings	Exact identifier application number: M020
Wellage Real Hyaluronic Watery Glow Sun Screen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Hugel, Inc.	37aa2f7b-afa4-5cc9-e063-6294a90ae741	2025-06-16	Warnings	Exact identifier application number: M020
Dermaka Sunscreen SPF 42, Tinted	TITANIUM DIOXIDE, ZINC OXIDE	DERMAKA SKIN PRODUCTS	9a967cd1-9eec-4255-b14b-ac2e33e4dbf0	2025-06-16	Warnings	Exact identifier application number: M020
Elizabeth Arden Eight Hour Hydraplay SPF 40	OCTISALATE, HOMOSALATE, AVOBENZONE, OCTOCRYLENE	Revlon Consumer Products Corp	2cc74177-0f62-106e-e063-6394a90a6e28	2025-06-16	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