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 190 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dolce and Gabbana Everlast Foundation SPF 20 38C Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	0358a87d-8002-4f3e-851a-3a582d356edf	2025-09-03	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 39N Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	34dfc4c5-44f7-4531-97ba-8846ebe14724	2025-09-03	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 40C Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	cf4b6f45-d4ae-4665-87b4-c5af4910befa	2025-09-03	Warnings	Exact identifier application number: M020
DOLCE and GABBANA MEET YOUR FLAWLESS MATTE SKIN DUO - EVERLAST PRIMER EVERLAST FOUNDATION	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	DOLCE & GABBANA BEAUTY SRL	eb63e9c6-bdb0-4bdf-8822-e4561a56adc9	2025-09-03	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 1N Light	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	9507681c-236c-41c1-9dc9-ed4c0c091741	2025-09-03	Warnings	Exact identifier application number: M020
Pure6 ManiShield Hand Screen	ZINC OXIDE, TITANIUM DIOXIDE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	3abcb6ba-1de8-55e7-e063-6294a90aecf1	2025-09-02	Warnings	Exact identifier application number: M020
Round Lab Dodo s Pick Bestseller Set	AVOBENZONE, HOMOSALATE, OCTISALATE	SEORIN COMPANY Co., Ltd.	3dd3db99-2e9f-16fc-e063-6294a90adda1	2025-09-02	Warnings	Exact identifier application number: M020
Sun Bum Premium Sunscreen Face Stick Broad Spectrum SPF 30 Sunscreen - Pegged	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3d86da52-6354-f53e-e063-6394a90aac55	2025-09-02	Warnings	Exact identifier application number: M020
Sheer Guard Natural Mineral Sunscreen Broad Spectrum SPF 50	ZINC OXIDE	Baxter Laboratories Pty	3dd711c1-7758-31da-e063-6294a90a4f38	2025-09-02	Warnings	Exact identifier application number: M020
Sun Bum Road Tripper Mineral - Mineral Sunscreen Broad Spectrum SPF 30	ZINC OXIDE	Sun Bum, LLC	3dd7b0af-dc37-1701-e063-6294a90a65c3	2025-09-02	Warnings	Exact identifier application number: M020
toty Ilumina CC Creamy Compact 6N	TITANIUM DIOXIDE	Chipican LLC	3da732e7-19b0-3195-e063-6394a90a9a0c	2025-09-01	Warnings	Exact identifier application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 4	ENSULIZOLE ,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDE	Hangzhou Jingshen Trading Co., Ltd.	3dba1360-f70f-e450-e063-6394a90a8c9f	2025-09-01	Warnings	Exact identifier application number: M020
TOCOBO Cotton Airy Sun Stick	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	PICTON CO., Ltd.	2f7e7ef4-c3ac-4c26-e063-6394a90a9e42	2025-09-01	Warnings	Exact identifier application number: M020
TOCOBO Bio Watery Sun Screen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	PICTON CO., Ltd.	3a7db6f4-66fd-4473-e063-6394a90a886e	2025-09-01	Warnings	Exact identifier application number: M020
TOCOBO Bio Watery Sun Screen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	PICTON CO., Ltd.	2f7eb413-ff49-711d-e063-6394a90ad6dc	2025-09-01	Warnings	Exact identifier application number: M020
Ocean Potion Suncare Mineral 30 Essential Scent of Sunshine Zinc Oxide Sunscreen	ZINC OXIDE	GNL BRANDS INTERNATIONAL, LLC	3db1cf3e-0640-6821-e063-6294a90a7036	2025-08-31	Warnings	Exact identifier application number: M020
Purpose Dual Treatment SPF 10	OCTINOXATE 7.5%, OCTISALATE 5%, OXYBENZONE 3%	Elysium Consumer Healthcare LLC	3d7fe711-a671-df30-e063-6394a90afbbf	2025-08-29	Warnings	Exact identifier application number: M020
Good Weather Skin The One Daily Sun Warm Glow SPF 30	ZINC OXIDE	Good Weather Inc.	3d83aaa5-0e4e-928a-e063-6294a90a24da	2025-08-29	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 33N Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	e249507c-d536-4c1d-a99d-857ca1e833d8	2025-08-29	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 32W Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	ba99edea-bf68-4118-8bb7-ea40322db46a	2025-08-29	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