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 275 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IPKN Moist and Firm Beauty Balm Light MediumTITANIUM DIOXIDEInel Cosmetics Co., Ltd.1af6184e-3dc4-4eb3-8d51-aca7244734512024-10-25WarningsExact identifier
application number: M020
IPKN Moist and Firm Beauty Balm LightTITANIUM DIOXIDEInel Cosmetics Co., Ltd.77d77838-aa13-4939-a1a0-50189fbb3fe02024-10-25WarningsExact identifier
application number: M020
Dove Men plus Care Hydrate FaceAVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENECONOPCO Inc. d/b/a Unileverafe75aff-c056-eaf7-e053-2a95a90af71b2024-10-24WarningsExact identifier
application number: M020
Cancer Council Mineral Fluid SPF50ZINC OXIDEVitality US Co.1638f8a4-a2da-4e1f-e063-6294a90a03d92024-10-24WarningsExact identifier
application number: M020
Marlowe SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMarlowe Holdings, LLCf94bd91a-f0ab-680c-e053-6394a90ac8552024-10-23WarningsExact identifier
application number: M020
Vacation Broad Spectrum SPF 30HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEVacation Inc.2526eadf-4b55-ff81-e063-6394a90a3ba72024-10-23WarningsExact identifier
application number: M020
Tenacious ErgodyneKREWD CLEAR SPF 50 CONTINUOUS SPRAYTenacious Holdings, Inc.55d99d0a-dc7f-4915-b7c1-f999c8b36e0d2024-10-23WarningsExact identifier
application number: M020
Tenacious ErgodyneSPF 50 SUNSCREEN LOTIONTenacious Holdings, Inc.aaaa1f54-1136-4062-85ba-0926351580bb2024-10-23WarningsExact identifier
application number: M020
Bull Frog SPF 50 Quik with Water Armor TechAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBULLFROG BRANDS, LLC.f706f90c-eb79-2201-e053-6394a90a2ce42024-10-23WarningsExact identifier
application number: M020
Bull Frog SPF 50 Quik with Water Armor TechAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBULLFROG BRANDS, LLC.f70816a3-cc04-b000-e053-6294a90a0fae2024-10-23WarningsExact identifier
application number: M020
Alumier MD Post Procedure KitTITANIUM DIOXIDE, ZINC OXIDEAlumier Labs252859de-6676-5e07-e063-6394a90a64a12024-10-23WarningsExact identifier
application number: M020
Equate Sunscreen Tanning Oil With Coconut Oil SPF 6AVOBENZONE, HOMOSALATEWAL-MART STORES INC.f44d83d3-ffca-7a93-e053-2a95a90a77152024-10-23WarningsExact identifier
application number: M020
Tanning Sunscreen UVB Protection Dry Oil EquateAVOBENZONE, HOMOSALATE, OCTISALATEWAL-MART STORES INC.acdf62f2-742e-5df9-e053-2a95a90a96c52024-10-23WarningsExact identifier
application number: M020
WALMART EQUATE BEAUTY ULTRA LIGHT SUNSCREEN SPF 100AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEWAL-MART STORES INC.c8d4feca-7bee-2413-e053-2a95a90a739c2024-10-23WarningsExact identifier
application number: M020
Equate Sunscreen for All Skin Tones SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWal-Mart Stores Incf410ffcc-ef0e-13c4-e053-2a95a90a568a2024-10-23WarningsExact identifier
application number: M020
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 44NHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDERare Beauty, LLCcffbb6af-5a04-f58a-e053-2995a90a1ae22024-10-23WarningsExact identifier
application number: M020
Banana BoatTITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands, LLC441a46f0-ecda-4448-e054-00144ff88e882024-10-23WarningsExact identifier
application number: M020
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 28CHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDERare Beauty, LLCcffb8219-7076-de64-e053-2a95a90a60362024-10-23WarningsExact identifier
application number: M020
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 10NHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDERare Beauty, LLCcfee02eb-92f9-be12-e053-2a95a90a43372024-10-23WarningsExact identifier
application number: M020
CVS Pharmacy Kids SPF 70 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS Pharmacy4eb824a6-66ac-01f8-e054-00144ff8d46c2024-10-22WarningsExact 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