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 284 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topco Topcare Everyday Mineral Sunscreen Continuous SPF 30	ZINC OXIDE	TOPCO ASSOCIATES LLC	f71e019b-392a-f8eb-e053-6394a90a871e	2024-10-15	Warnings	Exact identifier application number: M020
TOPCARE EVERYDAY SPORT SPF 70 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	TOPCO ASSOCIATES LLC	a5b06600-f2b0-6d9b-e053-2995a90a59f0	2024-10-15	Warnings	Exact identifier application number: M020
TopCare Everyday Ultra Protection Sun SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TOPCO ASSOCIATES LLC	f41d4c46-7998-afe6-e053-2995a90ab361	2024-10-15	Warnings	Exact identifier application number: M020
TOPCO TOPCARE EVERYDAY BABY PROTECTION SUN SPF 50	OCTISALATE, ZINC OXIDE	TOPCO ASSOCIATES LLC	f71c9060-3daf-e1be-e053-6294a90a4f91	2024-10-15	Warnings	Exact identifier application number: M020
MINERAL SUNSCREEN SPF 50	ZINC OXIDE, TITANIUM DIOXIDE	TOPCO ASSOCIATES LLC	bfe076fa-f21f-2c46-e053-2a95a90acee4	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Mineral Sunscreen Stick	ZINC OXIDE	H.E.B.	f58f0199-bf22-2197-e053-2995a90ae64f	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Kids Blue Mineral Sunscreen Stick Berry Scented	ZINC OXIDE	H.E.B.	f58d328c-8b30-b4d4-e053-2a95a90adb59	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Kids Purple Mineral Sunscreen Stick Grape Scented	ZINC OXIDE	H.E.B.	f58ed2f9-67c3-ce91-e053-2995a90a1229	2024-10-15	Warnings	Exact identifier application number: M020
HEB Shimmer Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f5930029-4c96-2576-e053-2995a90a7bed	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Birthday Cake Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f5a3313e-4935-1ce3-e053-2a95a90a6ad1	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 White Gardenia Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f5b6caf2-ebff-79fb-e053-2995a90ac2f8	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 For Men Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE,OCTOCRYLENE	H.E.B	f59461e3-9521-6a7b-e053-2a95a90a73b8	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Pink Peony Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE,OCTOCRYLENE	H.E.B	f5a2c266-6fc9-21ae-e053-2995a90aec0e	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Pink Peony Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f5b7172a-b8fc-0d11-e053-2a95a90a9f73	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Peach Bellini Scented Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f5cbac04-361f-9226-e053-2995a90a2d7b	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Cucumber Water Scented Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f5d933cf-3461-8b03-e053-2a95a90ad79f	2024-10-15	Warnings	Exact identifier application number: M020
HEB Oil Free Facial Moisturizer with Sunscreen Broad Spectrum SPF 15	AVOBENZONE, OCTISALATE, OCTOCRYLENE	H.E.B	f6ce4ea0-d92f-368c-e053-6294a90a2a81	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 White Gardenia Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE,OCTOCRYLENE	H.E.B	f5a2702c-5451-58a1-e053-2a95a90adb8e	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Strawberry Daquiri Scented Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f5cb5f9a-6691-37c3-e053-2a95a90a9af0	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Rosewater Scented Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f5db7ec6-0e9b-7044-e053-2a95a90a1e48	2024-10-15	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