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 288 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SIGNATURE CARE SPORT SPF 30 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	SAFEWAY, INC.	a6296612-184c-6b3c-e053-2a95a90a34b9	2024-10-14	Warnings	Exact identifier application number: M020
OPEN NATURE SPF 50 MINERAL SUNSCREEN	ZINC OXIDE	SAFEWAY, INC.	a6020d2f-55c4-adfc-e053-2a95a90ad238	2024-10-14	Warnings	Exact identifier application number: M020
OPEN NATURE CHILDREN SPF 50 MINERAL SUNSCREEN	ZINC OXIDE	SAFEWAY, INC.	a6044f0f-eb86-684d-e053-2995a90a0921	2024-10-14	Warnings	Exact identifier application number: M020
SIGNATURE CARE SPORT SPF 50 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	SAFEWAY, INC.	a62848fb-7016-3457-e053-2a95a90aa0f1	2024-10-14	Warnings	Exact identifier application number: M020
Safeway Signature Care Sport Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Safeway, Inc.	c6a0ae3e-d68a-b838-e053-2a95a90a77f7	2024-10-14	Warnings	Exact identifier application number: M020
SIGNATURE CARE SPORT SPF 30 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	SAFEWAY, INC.	a628ff71-463d-4d39-e053-2995a90a7a42	2024-10-14	Warnings	Exact identifier application number: M020
CVS Health SPF 70 Ultra Sheer	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Safeway, Inc.	c5106c63-af51-c169-e053-2a95a90afef2	2024-10-14	Warnings	Exact identifier application number: M020
Safeway Signature Care Dry Touch Sunscreen SPF 55	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Safeway, Inc.	c6267a29-46a5-5f38-e053-2a95a90a0117	2024-10-14	Warnings	Exact identifier application number: M020
Open Nature Zinc Oxide Sunscreen Mineral Sunscreen SPF 30	ZINC OXIDE	Safeway, Inc.	dbeff8e8-250d-8274-e053-2995a90a984e	2024-10-14	Warnings	Exact identifier application number: M020
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 10N	HOMOSALATE, ZINC OXIDE	Rare Beauty, LLC	2460281d-d433-0216-e063-6394a90a9d48	2024-10-13	Warnings	Exact identifier application number: M020
Walgreens 50 Coconut Scented Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	2436987c-2afe-06b5-e063-6394a90aceba	2024-10-11	Warnings	Exact identifier application number: M020
Walgreens 50 Banana Scented Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	2436bd19-2299-6e89-e063-6394a90acd99	2024-10-11	Warnings	Exact identifier application number: M020
Walgreens SPF 50 Clear Complexion Face Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	f07238df-4970-7759-e053-2a95a90a39f9	2024-10-11	Warnings	Exact identifier application number: M020
Walgreens SPF 70 Sport Continuous	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENE	WALGREEN COMPANY	e7165b39-54f9-4af6-e053-2a95a90af664	2024-10-11	Warnings	Exact identifier application number: M020
WALGREENS SPF 100 SHEER BODY SUNSCREEN MIST	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	f14bb3b4-1dce-06b9-e053-2995a90a8bc8	2024-10-11	Warnings	Exact identifier application number: M020
Walgreens SPF 30 Sport	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	f12c9767-7cb7-12c8-e053-2995a90a17be	2024-10-11	Warnings	Exact identifier application number: M020
Sulwhasoo UV Daily Cream	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CREAM	Amorepacific Corporation	e00451d5-8433-c4e8-e053-2a95a90a6244	2024-10-11	Warnings	Exact identifier application number: M020
Walgreens SPF 50 Sport Continuous Sunscreen	AVOBENZONE, HOMOSALAT, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	f13ec3da-2dc2-04f7-e053-2995a90a198d	2024-10-11	Warnings	Exact identifier application number: M020
Walgreens SPF 30 Hydrating	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	f4155692-16a7-11e8-e053-2995a90abd34	2024-10-11	Warnings	Exact identifier application number: M020
Walgreens Daily Facial Moisturizer with Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	f906792b-083e-13e2-e053-6294a90ab4cf	2024-10-11	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