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 255 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BabyGanics Sunscreen 30 SPF	ZINC OXIDE, OCTINOXATE, AND OCTISALATE	KAS Direct LLC dba BabyGanics	391a4ec3-b65b-4dbe-bc8f-cb67514c8ef1	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 PORCELAIN	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299ac9a5-f609-d804-e063-6394a90abd05	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 IVORY	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299ad424-16a8-66b1-e063-6394a90a0753	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 NUDE	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299afef9-758f-74e1-e063-6294a90a8072	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 NATURAL BEIGE	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299b3276-7973-d33f-e063-6294a90a6ce1	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 CLASSIC TAN	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299afe24-d496-5745-e063-6394a90aa1b3	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 WARM BEIGE	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299b1f9a-34fd-cb50-e063-6394a90af925	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 SOFT SAND	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299b3236-3f3d-c9e8-e063-6394a90a7443	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 TAWNY	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299b416d-ce02-3462-e063-6294a90a38f0	2024-12-19	Warnings	Exact identifier application number: M020
Puttisu	TITANIUM DIOXIDE, ZINC OXIDE	Jellycup, Inc.	a032331a-6724-d2cd-e053-2995a90ac15a	2024-12-19	Warnings	Exact identifier application number: M020
Dr. C. Tuna Resurface Essential Day Cream SPF 30	HOMOSALATE, OCTINOXATE, OCTOCRYLENE, AVOBENZONE	Farmasi US LLC	de493e30-d135-9def-e053-2995a90ae49a	2024-12-19	Warnings	Exact identifier application number: M020
toty Ilumina CC Cream 1N	TITANIUM DIOXIDE, ZINC OXIDE	Chipican LLC	e4efe14e-7d46-78c0-e053-2995a90a2364	2024-12-19	Warnings	Exact identifier application number: M020
Aruba Sun SPF 50 Sunscreen	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Derma Care Research Labs, LLC	d8b28ce6-e938-c6e3-e053-2a95a90acc29	2024-12-19	Warnings	Exact identifier application number: M020
DCH Pain Relief Roll-On	LIDOCAINE HCL 4%	Derma Care Research Labs, LLC	fda35d37-f36e-efc8-e053-6294a90a2bb8	2024-12-19	Warnings	Exact identifier application number: M020
Black Girl Sunscreen SPF 50 Kids	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Derma Care Research Labs, LLC	d53ff8f5-0b06-1e8b-e053-2a95a90ab924	2024-12-19	Warnings	Exact identifier application number: M020
Fresh Coast SPF 50 Sunscreen	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Derma Care Research Labs, LLC	043cadde-ba07-7c77-e063-6394a90abee6	2024-12-19	Warnings	Exact identifier application number: M020
Black Girl Sunscreen SPF 30	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 8%	Derma Care Research Labs, LLC	d438be95-0f88-69d7-e053-2995a90a982e	2024-12-19	Warnings	Exact identifier application number: M020
Pavin SPF 50 Sunscreen	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Derma Care Research Labs, LLC	e945f9df-0aed-469c-e053-2995a90ab6aa	2024-12-19	Warnings	Exact identifier application number: M020
Bee Bald Smooth Plus Daily Moisturizer SPF 30 Sunscreen	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 2.7%, OXYBENZONE 6%	Derma Care Research Labs, LLC	051b68f9-5d6b-3cd7-e063-6394a90aeb35	2024-12-19	Warnings	Exact identifier application number: M020
MKMen Advanced Facial Hydrator Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Mary Kay Inc.	484e92db-09a2-4e93-aa7e-d91dbda31555	2024-12-19	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