FDA.reportPublic FDA data

Mineral Lip Protection

Product NDC
85563-212
11-digit product format
855630212
Labeler code
85563
Product ID
85563-212_46041f25-f600-ee00-e063-6394a90aaa56
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
STICK
Route
TOPICAL
Labeler
CLEAR SKIN SOLUTIONS, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-11
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
55; 40 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
Mineral Lip Protection
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE55 mg/g
TITANIUM DIOXIDE40 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
35bd148c-43c7-aa93-e063-6394a90abc8bAvailable 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
85563-212-45Mineral Lip Protection4.5 g in 1 CYLINDERSTICK4.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85563-212MINERAL LIP PROTECTION (TITANIUM DIOXIDE, ZINC OXIDE) STICK [CLEAR SKIN SOLUTIONS, LLC]1Current NDC, 1 package rows20250523_35bd148c-43c7-aa93-e063-6394a90abc8b.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 113 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral SunscreenZINC OXIDEWECARE FRISCO PLLC37507b14-fc01-5e27-e063-6294a90afd502025-12-16Exact identifier
application number: M020
Non-Tinted Mineral SunscreenZINC OXIDEWECARE FRISCO PLLC375203a6-2ab8-2a80-e063-6294a90ada722025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenZINC OXIDEWECARE FRISCO PLLC3751caa3-867e-5901-e063-6294a90ab6bd2025-12-16Exact identifier
application number: M020
Auset Tinted Replenishing Daily ProtectionZINC OXIDESHAYLA BOGER SKIN THERAPY LLC37da48d6-8f12-ec97-e063-6294a90a699c2025-12-16Exact identifier
application number: M020
Morning ReplenishZINC OXIDEKATHY JONES AESTHETHICS LLC37da711e-840b-2f2a-e063-6294a90ab16c2025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEKATHY JONES AESTHETHICS LLC37dab729-5988-5eba-e063-6294a90ac6b72025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETory Sullivan, M.D., P.A.36241e60-f02a-50a7-e063-6394a90a63902025-12-16Exact identifier
application number: M020
Ageless All FitzZINC OXIDEA.Wall Beauty LLC37670cb1-ac75-5049-e063-6394a90a4d0a2025-12-16Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDETory Sullivan, M.D., P.A.36244b27-20e5-f370-e063-6294a90a1f6c2025-12-16Exact identifier
application number: M020
UV Defense Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECCLEAR SOLUTIONS ACNE & SKIN CARE CLINIC365e09a8-308b-b753-e063-6394a90ae9e52025-12-16Exact identifier
application number: M020
UV Defense Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDECCLEAR SOLUTIONS ACNE & SKIN CARE CLINIC365e2498-7df2-f22c-e063-6294a90ac6ab2025-12-16Exact identifier
application number: M020
UV Protection Veil Mineral Sunscreen non tintedTITANIUM DIOXIDE, ZINC OXIDEATHENA PLASTIC SURGERY3b3bf5a6-33ec-0255-e063-6294a90ac96a2025-12-16WarningsExact identifier
application number: M020
UV Protection Veil Mineral Sunscreen, tintedTITANIUM DIOXIDE, ZINC OXIDEATHENA PLASTIC SURGERY3b3cba2e-acc6-a2df-e063-6294a90abf712025-12-16WarningsExact identifier
application number: M020
Color Smart Tinted MineralZINC OXIDEMEGAN YORK INC.365c4623-94d5-e8b6-e063-6394a90a966a2025-12-16Exact identifier
application number: M020
Anti-Aging Tinted SunscreenZINC OXIDEKARINA SALDIVAR3bca508e-7bd0-d45d-e063-6394a90a17302025-12-16WarningsExact identifier
application number: M020
UV Protection Veil Mineral Sunscreen, tintedTITANIUM DIOXIDE, ZINC OXIDEATHENA PLASTIC SURGERY3b3c757f-6581-4978-e063-6294a90a61732025-12-16WarningsExact identifier
application number: M020
Kind Restore Tinted Mineral SunscreenZINC OXIDEPOLISH BEAUTY3980810f-58b5-3a60-e063-6294a90a9c072025-12-16Exact identifier
application number: M020
Daydream Beyond ScreenZINC OXIDEULTRAVIOLET SKINCARE LLC36bfd963-d123-0d25-e063-6294a90aa8272025-12-16Exact identifier
application number: M020
Virgo SOL Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEULTRAVIOLET SKINCARE LLC369d4f43-8c57-9fcf-e063-6294a90aa9162025-12-16Exact identifier
application number: M020
Virgo SOL Non Tinted MousseTITANIUM DIOXIDE, ZINC OXIDEULTRAVIOLET SKINCARE LLC369d63a9-b9ab-9530-e063-6394a90ac8ef2025-12-16Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85563-212-45855630212454.5 g in 1 CYLINDER (85563-212-45) 4.5 g2019-07-11NoNoCurrent