FDA.reportPublic FDA data

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
IngredientStrength
TITANIUM DIOXIDE40 mg/g
ZINC OXIDE55 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
479a7d82-a068-4c2e-b50b-555c40e13e37Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58892-124-45CoTZ Lip Balm1 in 1 CARTONSTICK12
58892-124-45CoTZ Lip Balm4.5 g in 1 TUBESTICK4.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-124COTZ LIP BALM (TITANIUM DIOXIDE, ZINC OXIDE) STICK [FALLIEN COSMECEUTICALS, LTD]2Current NDC, Legacy NDC, 2 package rows20241114_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 256 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPF 50 Sunscreen UnfragrancedAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Derma Care Research Labs, LLC05e4706b-1955-aba8-e063-6294a90a29c72024-12-19WarningsExact identifier
application number: M020
Rubber Ducky SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Derma Care Research Labs, LLCcf32b3a0-de88-b866-e053-2a95a90a3f322024-12-19WarningsExact identifier
application number: M020
SPF 50 Sunscreen Rocky MountainAVOBENZONE 3%, HOMOSALATE 10%, OCTOCRYLENE 6%Derma Care Research Labs, LLCa216d48f-4ed4-6008-e053-2a95a90a8c9a2024-12-19WarningsExact identifier
application number: M020
Rod and Rifle SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 10%, OCTOCRYLENE 6%Derma Care Research Labs, LLCfc61847b-cb61-97b1-e053-6394a90ae1b92024-12-19WarningsExact identifier
application number: M020
Habana Brisa SPF 30 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 6%Derma Care Research Labs, LLCdb0d6dec-d0ee-6160-e053-2a95a90a2c6e2024-12-19WarningsExact identifier
application number: M020
Caribbean Breeze SPF 30 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 8%Derma Care Research Labs, LLCf8730f9c-43c1-f4d3-e053-6294a90a18092024-12-19WarningsExact identifier
application number: M020
Caribbean Breeze SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Derma Care Research Labs, LLCf8735925-dcb2-6723-e053-6294a90a51f42024-12-19WarningsExact identifier
application number: M020
Caribbean Breeze SPF 70 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Derma Care Research Labs, LLCf873c125-86b8-3d1d-e053-6394a90a6bcf2024-12-19WarningsExact identifier
application number: M020
Royal Boost Cover Me Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.efd7d887-0616-4c76-84d8-5370eb63cb7f2024-12-19WarningsExact identifier
application number: M020
Rubber Ducky SPF 50 Unfragranced SunscreenAVOBENZONE 3%, HOMOSALATE 10%, OCTOCRYLENE 6%Derma Care Research Labs, LLC043b447c-4519-37ce-e063-6394a90a71972024-12-19WarningsExact identifier
application number: M020
Australian Sands SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Derma Care Research Labs, LLCf886a02f-c043-b281-e053-6294a90af7462024-12-19WarningsExact identifier
application number: M020
SPF 50 Sunscreen Rocky MountainAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Derma Care Research Labs, LLCa1c9066c-4801-5aee-e053-2995a90a75d22024-12-19WarningsExact identifier
application number: M020
Dr. Throwers SPF 30 Face and Body SunscreenAVOBENZONE 3%, HOMOSALATE 12%, OCTISALATE 5%, OCTOCRYLENE 3%Derma Care Research Labs, LLCd680b6f6-e1a9-47a4-e053-2a95a90ae3b02024-12-19WarningsExact identifier
application number: M020
Vacation Broad Spectrum SPF 30HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEVacation Inc.29a7636c-4d99-2cac-e063-6394a90a74802024-12-19WarningsExact identifier
application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 CARAMELOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC29a82ba9-c0f8-0edf-e063-6294a90a50b42024-12-19WarningsExact identifier
application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 SABLEOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC29a8812b-70ff-e8aa-e063-6294a90a09f82024-12-19WarningsExact identifier
application number: M020
CLE CCC Neutral DeepTITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, AVOBENZONEKW ABSC, INC.3a548deb-3670-4c5b-a139-796701801fed2024-12-19WarningsExact identifier
application number: M020
CLE CCC Olive Medium DeepTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.be4434c0-cbdd-46cb-8015-4c7859e80d4a2024-12-19WarningsExact identifier
application number: M020
CLE CCC Golden MediumTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.de50e956-a014-4147-922b-63c95fa6f86b2024-12-19WarningsExact identifier
application number: M020
CLE CCC Neutral LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.44cbb226-83ed-401b-baf8-ca8e4740dbef2024-12-19WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58892-124-45588920124451 TUBE in 1 CARTON (58892-124-45) / 4.5 g in 1 TUBE1 tube2021-05-010000-00-00NoNoCurrent