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 249 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c64cc0-be42-c210-e063-6394a90a6d9a2024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c61c42-edda-1ebd-e063-6294a90aee132024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c62206-d839-8d9a-e063-6394a90a4c692024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c62206-d83b-8d9a-e063-6394a90a4c692024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c618ae-3d24-8c87-e063-6394a90a53962024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c62206-d830-8d9a-e063-6394a90a4c692024-12-26WarningsExact identifier
application number: M020
Bubble Solar Mate Daily Mineral Sunscreen SPF 40ZINC OXIDECOSMAX USA, CORPORATION0d35fa3c-e6eb-d9ff-e063-6394a90a5a6e2024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c6035e-c178-b3e6-e063-6394a90a86cd2024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c62206-d838-8d9a-e063-6394a90a4c692024-12-26WarningsExact identifier
application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 LightAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporationfbbff4eb-a63e-b083-e053-6294a90a404a2024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c6035e-c179-b3e6-e063-6394a90a86cd2024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c618ae-3d4d-8c87-e063-6394a90a53962024-12-26WarningsExact identifier
application number: M020
KOPARI Sun Shield Soft Glow Daily Face SPF30OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATECOSMAX USA, CORPORATION0d436d06-3f81-b4a6-e063-6294a90aa6352024-12-26WarningsExact identifier
application number: M020
NEORA Invisibloc Sunscreen Gel Broad Spectrum SPF40AVOBENZONE, HOMOSALATE, OCTISALATECOSMAX USA, CORPORATION0d584736-3f55-2542-e063-6294a90af3cf2024-12-26WarningsExact identifier
application number: M020
NARS Radiance Primer Broad Spectrum SPF 35 SunscreenOCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATECOSMAX USA, CORPORATION0d59d9cb-c891-1097-e063-6394a90a806e2024-12-26WarningsExact identifier
application number: M020
KOPARI Sun Shield Soft Glow Daily Face SPF30OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATECOSMAX USA, CORPORATION0d3673da-822b-09e2-e063-6394a90a348e2024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c61c42-eddb-1ebd-e063-6294a90aee132024-12-26WarningsExact identifier
application number: M020
GLOSSIER INVISIBLE SHIELD DAILY SUNSCREEN BROAD SPECTRUM SPF 35AVOBENZONE, HOMOSALATE, OCTISALATECOSMAX USA, CORPORATION0d438692-cd83-ea42-e063-6394a90a862d2024-12-26WarningsExact identifier
application number: M020
KOPARI Antioxidant Face Shield Mineral SPF 30ZINC OXIDECOSMAX USA, CORPORATION0d43e22c-5e3d-df90-e063-6294a90aac2b2024-12-26WarningsExact identifier
application number: M020
NORWEX Protect Prevent Mineral Facial Sunscreen Broad Spectrum SPF30TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, CORPORATION0d489154-6168-977e-e063-6394a90aa6092024-12-26WarningsExact 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