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
2027-12-31
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
2027-12-31

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 274 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Banana BoatAVOBENZONE, HOMOSALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC7961ff9f-75db-4977-e053-2a91aa0ae6282024-10-27WarningsExact identifier
application number: M020
Banana Boat Light as air face SUNSCREEN UVA UVB Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC8a1c9a3c-394e-9122-e053-2995a90acb232024-10-27WarningsExact identifier
application number: M020
Banana BoatAVOBENZONE, HOMOSALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC8b889b75-07ac-4276-e053-2a95a90a69c62024-10-27WarningsExact identifier
application number: M020
Banana Boat Ultra Sport Sunscreen Broad Spectrum SPF 15AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands, LLC9751a700-5d51-357b-e053-2a95a90af66c2024-10-27WarningsExact identifier
application number: M020
Banana Boat Sport Ultra Face SPF30AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCdc757b03-7e7d-b362-e053-2a95a90a84462024-10-27WarningsExact identifier
application number: M020
Banana Boat Kids Mineral Protection SPF50TITANIUM DIOXIDE,ZINC OXIDEEdgewell Personal Care Brands LLCdc7701b5-0c73-b4df-e053-2a95a90a0f1b2024-10-27WarningsExact identifier
application number: M020
Banana Boat Mineral Sensitive SPF 50TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCdc7913d5-58f2-3077-e053-2a95a90a16272024-10-27WarningsExact identifier
application number: M020
BANANA BOAT PROTECTION PLUS VITAMINS SUNSCREEN UVA/UVB BORAD SPECTRUM SPF 30AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCe5f9d56d-a80e-221c-e053-2a95a90aae922024-10-27WarningsExact identifier
application number: M020
Banana Boat Mineral Sensitive Face SPF50TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCdc783438-b28f-b7f4-e053-2a95a90a3d652024-10-27WarningsExact identifier
application number: M020
BANANA BOAT PROTECTION PLUS VITAMINS SUNSCREEN UVA/UVB BORAD SPECTRUM SPF 30AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCe53509bf-6bb7-2db7-e053-2a95a90aae182024-10-27WarningsExact identifier
application number: M020
Banana Boat Sport Mineral SPF 50TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCdc79790f-e2bc-5414-e053-2a95a90a9e7a2024-10-27WarningsExact identifier
application number: M020
Hawaiian Tropic Everyday Active SPF15AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCdc8ca3ed-5411-6278-e053-2995a90a0efc2024-10-27WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC16b4342e-6705-ca09-e063-6294a90a947d2024-10-27WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE, HOMOSALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC17670182-2b2e-ce40-e063-6294a90a29132024-10-27WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC16b3c10c-d98b-c424-e063-6394a90a77342024-10-27WarningsExact identifier
application number: M020
TiZO Mineral Stick - Tinted SPF 45TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTDfd6d0080-0bef-4e7e-8ca5-b859639efd0c2024-10-25WarningsExact identifier
application number: M020
Alumier MD Post Procedure Kit with HydrocortisoneTITANIUM DIOXIDE, ZINC OXIDE, HYDROCORTISONEAlumier Labs2551d748-c3d6-cd18-e063-6294a90adab62024-10-25WarningsExact identifier
application number: M020
TiZO Mineral Stick Non-Tinted SPF 45TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTDe7044f18-992a-4f60-9a2b-f11ed06db09b2024-10-25WarningsExact identifier
application number: M020
CoTZ Lip BalmTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD479a7d82-a068-4c2e-b50b-555c40e13e372024-10-25WarningsExact identifier
application number: M020
TiZO Mineral Sun Defense SPF 50TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.e17a8c35-2d49-4c99-b154-ea673c14753e2024-10-25WarningsExact 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