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 49 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hand Sunscreen Cream	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Jiangsu Senwo Medical Technology Co., Ltd.	4e615757-76b1-8f34-e063-6394a90a280a	2026-04-01	Warnings	Exact identifier application number: M020
All Good Mineral Sport Sunscreen Sunstick SPF 30	ZINC OXIDE	Elemental Herbs, Inc.	4e67b76e-b791-4e26-e063-6294a90aa991	2026-04-01	Warnings	Exact identifier application number: M020
All Good Coconut Mineral Sunscreen Sunstick SPF 30	ZINC OXIDE	Elemental Herbs, Inc.	4e67e89b-a7be-a540-e063-6294a90a6d8f	2026-04-01	Warnings	Exact identifier application number: M020
SHISEIDO BENEFIANCE WRINKLE SMOOTHING DAY	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Shiseido Americas Corporation	cad3a446-36a8-4146-81b5-1cc8d65abf14	2026-04-01	Warnings	Exact identifier application number: M020
MENOKIN 30 SECONDS GLOW AND CLEAR Gel SUNSCREEN BRIGHT	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Forest Avenue Co., Ltd.	8de4ec46-f60a-4c51-a16e-9140150e2162	2026-04-01	Warnings	Exact identifier application number: M020
ChapStick Moisturizer Cool Mint SPF 15	SPF 15 LIP PROTECTANT	Suave Brands Co., LLC	42f50497-ded1-6863-e063-6294a90a39c8	2026-03-31	Warnings	Exact identifier application number: M020
Purito Sunday Adventure Sunscreen SPF 50, 50 mL	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Hinature	bf16f535-97fc-4fd8-9310-8b6bbc82baae	2026-03-31	Warnings	Exact identifier application number: M020
spf 50 mineral powder sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Smalls Brand LLC DBA Roe Wellness	f8762dd1-0484-74ea-e053-6294a90ac112	2026-03-31	Warnings	Exact identifier application number: M020
Badger SPF 30 Face Mineral Sunscreen	ZINC OXIDE	W.S. Badger Company, Inc.	14a9b605-f1f0-00e5-e063-6394a90a5a51	2026-03-31	Warnings	Exact identifier application number: M020
Covergirl cgsmoothers BB Tinted Moisturizer Broad Spectrum SPF 21 (all shades)	OCTINOXATE AND ZINC OXIDE	Noxell Corporation	38bba282-b4f7-4374-8732-419400b1cc50	2026-03-31	Warnings	Exact identifier application number: M020
SeranovaTM ULTRALIGHT SPF50 SERUM	SERANOVATM ULTRALIGHT SPF50 SERUM	Guangzhou Ariel Biotech Co., Ltd.	4e5d716d-2b2d-d42f-e063-6294a90a1e52	2026-03-31	Warnings	Exact identifier application number: M020
ageLOC Tru Face Radiant Day	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	NSE Products, Inc.	3e9a0b39-4351-41df-81b2-88c1c15c0db2	2026-03-31	Warnings	Exact identifier application number: M020
Sunright Solar Screen Mineral Face Sunscreen	ZINC OXIDE	NSE Products, Inc.	93a32040-3a47-4d6f-baa1-5a4595bef410	2026-03-31	Warnings	Exact identifier application number: M020
Lancome Paris Renergie HPN 300 Peptide Sunscreen Broad Spectrum SPF 25 High-Performance Day	AVOBENZONE, OCTISALATE, AND OCTOCRYLENE	L'Oreal USA Products Inc	28f500e2-41d1-4747-8f26-3f6f8cc1b583	2026-03-30	Warnings	Exact identifier application number: M020
Lancome Paris Renergie HPN 300 Peptide Sunscreen Broad Spectrum SPF 25 High-Performance Day	AVOBENZONE, OCTISALATE, AND OCTOCRYLENE	SICOS ET CIE	dd448b7a-2554-4dfc-9eb3-ec3486ec6197	2026-03-30	Warnings	Exact identifier application number: M020
ANUA MINERAL WEIGHTLESS FINISH SUNSCREEN	ZINC OXIDE	Thefounders	4e37d291-84fb-252a-e063-6294a90acd1f	2026-03-30	Warnings	Exact identifier application number: M020
Beyond Glow Tinted Mineral Sunscreen Broad Spectrum SPF 50	ZINC OXIDE	THE AVON COMPANY	4e43bea2-247d-fe11-e063-6294a90a33a3	2026-03-30	Warnings	Exact identifier application number: M020
Abib Quick sunstick Protection bar	HOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONE	FOURCOMPANY CO., LTD.	1a2ab632-643f-1aa9-e063-6394a90a0c05	2026-03-30	Warnings	Exact identifier application number: M020
ChapStick Classic Original Military	SKIN PROTECTANT LIP BALM	Suave Brands Co., LLC	4514490b-f348-4526-e063-6294a90ad505	2026-03-30	Warnings	Exact identifier application number: M020
ChapStick Moisturizer Black Cherry SPF 15	SPF 15 SKIN PROTECTANT	Suave Brands Co., LLC	42f40978-51ca-f448-e063-6294a90acf31	2026-03-30	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