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 270 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZO Skin Health Sunscreen Plus Powder Broad-Spectrum SPF 45ZINC OXIDEZO Skin Health, Inc.be3c7ef2-dd08-0f1a-e053-2995a90ae14c2024-11-12WarningsExact identifier
application number: M020
TiZO Photoceutical AM Replenish - TintedZINC OXIDEFallien Cosmeceuticals, LTDfbafa468-fce0-4597-bcb0-a816dc71ec7c2024-11-12WarningsExact identifier
application number: M020
Sunscreen Plus Powder Broad-Spectrum SPF 45ZINC OXIDEZO Skin Health, Inc.beb0b43b-a90d-05ae-e053-2995a90a1d8e2024-11-12WarningsExact identifier
application number: M020
Neutrogena Healthy Skin Anti-Aging Perfector Sunscreen Broad Spectrum SPF 20 Ivory to Fair 10OCTINOXATE AND OCTISALATEKenvue Brands LLC0e489dec-9c7e-48c1-98cb-1aec91884a162024-11-11WarningsExact identifier
application number: M020
Neutrogena Revitalizing Lip Balm SPF 20 - Sheeer Shimmer 10OCTINOXATE AND OXYBENZONEKenvue Brands LLCe77c07d4-4e64-4000-9e7a-963aa6c6448c2024-11-11WarningsExact identifier
application number: M020
Neutrogena Sheer Zinc DRY-TOUCH Sunscreen Broad Spectrum SPF50ZINC OXIDEKenvue Brands LLC54a3b677-4510-4191-8386-ccdd10ccfcaa2024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4.5WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior504d8118-f84d-4f3f-abd1-463f3780a2cb2024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2WOOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior0d4e667a-cf93-4f6d-8565-ecfa9a18cfbf2024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2.5WOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorcb1d643e-34dc-48f2-aecd-ba2a35dc34032024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior097b3d7b-5dff-4206-99f1-6573902232e92024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4WOCTISALATE, TITANIUM DIOXIDEParfums Christian Diora621a610-7dd2-4ccd-bc48-8671e4f4a8872024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior43296d42-7bc2-4073-8231-4a7921f9ebe32024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 6NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5ee35643-bd86-4d55-914a-96f4670bfd072024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4WPOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorf519aa3f-11a1-4941-bf31-47ac11f5a7032024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4WOOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior03f0ad8b-25b1-4b01-abad-d1b0851e15c52024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3CROCTISALATE, TITANIUM DIOXIDEParfums Christian Diora6363bc5-6a99-4412-ba62-ec66054e2c712024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 1.5WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior9b2133dd-5dd0-476d-98c7-7f2e72024de72024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3WPOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5b74e312-39b1-4b11-a678-b4fccea845812024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3WOOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorf5a006d1-e957-4063-9b45-2874a1445a332024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2WPOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6943a531-c4e7-4e98-9970-3a30b9681b7b2024-11-11WarningsExact 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