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 233 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Perfect Sunscreen Tinted Mineral SPF50	ZINC OXIDE	Bluemercury, Inc.	4c978154-679f-472a-95ab-56878c5c70cd	2025-01-29	Warnings	Exact identifier application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	BELLE MEDICAL LLC	2cdc69d3-2192-7a38-e063-6294a90a257f	2025-01-29	Warnings	Exact identifier application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	Boxbar Beauty LLC	2d04c5e7-f3aa-873f-e063-6294a90a33d2	2025-01-29	Warnings	Exact identifier application number: M020
SEAWEED BATH CO. Super Sheer Face Serum SPF-50	ZINC OXIDE	The Seaweed Bath Co.	a45b46f9-681f-4a8d-b561-165b995ccf80	2025-01-28	Warnings	Exact identifier application number: M020
TiZO Photoceutical AM Replenish Non-Tinted	ZINC OXIDE	Fallien Cosmeceuticals, LTD	2cc62961-dcef-d7db-e063-6394a90a9ebd	2025-01-28	Warnings	Exact identifier application number: M020
Every Sun Day Ultra-Sheer Priming Sunscreen Stick	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Have & Be Co., Ltd.	2b53aa68-9c05-1682-e063-6294a90a968c	2025-01-28	Warnings	Exact identifier application number: M020
TiZO Photoceutical AM Replenish - Tinted	ZINC OXIDE	Fallien Cosmeceuticals, LTD	2cc73c4f-30ea-0a51-e063-6394a90ac9a4	2025-01-28	Warnings	Exact identifier application number: M020
TiZO Photoceutical AM Replenish - Tinted	ZINC OXIDE	Fallien Cosmeceuticals, LTD	2cc84aba-006b-a78e-e063-6294a90ae040	2025-01-28	Warnings	Exact identifier application number: M020
TiZO Mineral Sun Defense SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals Ltd.	2cc8f7ef-eda3-fe71-e063-6394a90a6a9a	2025-01-28	Warnings	Exact identifier application number: M020
Baby Diaper Rash Cream	ZINC OXIDE	doTERRA International, LLC	641465a1-0daf-1bb9-e053-2a91aa0ab25d	2025-01-28	Warnings	Exact identifier application number: M020
HydroPeptide S.P.F. Sun Protection Friends	TITANIUM DIOXIDE, ZINC OXIDE	HydroPeptide LLC	f3669a1e-8b75-4e94-a3f0-71dcbc3fa914	2025-01-28	Warnings	Exact identifier application number: M020
doTERRA sun Face Daily Moisturizer	ZINC OXIDE	doTERRA International, LLC	f3836517-e3ec-5e9e-e053-2a95a90a7af1	2025-01-28	Warnings	Exact identifier application number: M020
doTERRA sun	ZINC OXIDE	doTERRA International, LLC	da5c48d6-1859-983d-e053-2a95a90a4c3e	2025-01-28	Warnings	Exact identifier application number: M020
doTERRA sun	ZINC OXIDE	doTERRA International, LLC	dd2fa6a2-2ba8-4333-e053-2a95a90a9790	2025-01-28	Warnings	Exact identifier application number: M020
Tri-water sheer mineral sunscreen cushion SPF30	ZINC OXIDE	Eden Brands Inc.	2cd22172-78cb-32f3-e063-6394a90a395d	2025-01-28	Warnings	Exact identifier application number: M020
SOS Face Guard Broad Spectrum Sunscreen SPF 30	ZINC OXIDE	Tower 28	6687006a-bd79-4e1c-a546-0f0b51b29948	2025-01-28	Warnings	Exact identifier application number: M020
LBEL CONCENTRE GLOBAL ANTI AGING SERUM CONCEALER SPF 15 EYES FACE ALMENDRA 230	OCTINOXATE, ZINC OXIDE	BEL STAR S.A.	2cb1a767-3228-71ea-e063-6294a90ac89e	2025-01-27	Warnings	Exact identifier application number: M020
Meijer SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Meijer	26f7566e-5a89-21cf-e063-6294a90ac886	2025-01-27	Warnings	Exact identifier application number: M020
TiZO Photoceutical AM Replenish Non-Tinted	ZINC OXIDE	Fallien Cosmeceuticals, LTD	2cb77125-ff77-2060-e063-6294a90ab69f	2025-01-27	Warnings	Exact identifier application number: M020
GLOW RECIPE WATERMELON GLOW DEW SHIELD HYDRATING FLUID SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE	Aramara Beauty LLC dba Glow Recipe	2cb90666-6517-a02c-e063-6294a90ab062	2025-01-27	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