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 191 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dolce and Gabbana Everlast Foundation SPF 20 34W DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L3a239897-9850-417f-8c00-e810a52540c12025-08-29WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 36N DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lc495afc3-6486-4652-b743-958f28eccaca2025-08-29WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 35W DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L5440ed13-b07e-4c81-a407-d9ac68eaa4832025-08-29WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 37W DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L9b2c4567-fde7-4b76-9988-b2cba2d3747e2025-08-29WarningsExact identifier
application number: M020
Neutrogena Hydro Boost Hyaluronic Acid Moisturizer Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC3abd12f4-cbe3-4dd7-e063-6394a90a50a22025-08-28WarningsExact identifier
application number: M020
Sun Bum 15 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3d49b054-9f49-17d1-e063-6294a90a757a2025-08-28WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 2ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3d55291c-9d4c-85c3-e063-6394a90af3302025-08-27WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 3ENSULIZOLE ,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3d565612-ade5-bfb3-e063-6294a90a0c652025-08-27WarningsExact identifier
application number: M020
Jack Black Double DutyAVOBENZONE OCTOCRYLENEJack Black L.L.C.36d81d6d-4f9b-692d-e063-6294a90ad5592025-08-27WarningsExact identifier
application number: M020
Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - SandbarHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDESun Bum, LLC3ac57c70-9298-cbe7-e063-6394a90aefc12025-08-27WarningsExact identifier
application number: M020
Sun Bum 30 Mineral Tinted Sunscreen FaceTITANIUM DIOXIDE, ZINC OXIDESun Bum, LLC3a290aad-7f40-cb10-e063-6394a90a2e692025-08-27WarningsExact identifier
application number: M020
Broad Spectrum SPF 30 sunscreenHOMOSALATE 7.5%, OCTISALATE 5.0%, AVOBENZONE 3.0%Florida Squeezeda01f0ab9-d686-4ee1-be39-fd4c061cb0182025-08-26WarningsExact identifier
application number: M020
Sun Bum 50 Mineral Sunscreen Face StickZINC OXIDESun Bum, LLC3d48d467-4b6b-c477-e063-6294a90a5a0d2025-08-26WarningsExact identifier
application number: M020
PAPATUI Facial Moisturizer Broad Spectrum SPF 30ZINC OXIDEPAPATUI, LLC3d4ab3a5-a29b-bdd9-e063-6294a90a542c2025-08-26WarningsExact identifier
application number: M020
Broad Spectrum SPF 50 sunscreenHOMOSALATE 10%, OCTISALATE 5.0%, AVOBENZONE 3.0%Florida Squeezed34ffc25c-16e3-4c7c-9d46-9d9f279c074b2025-08-26WarningsExact identifier
application number: M020
Premium Moisturizing Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC36da7117-1c8e-7fcf-e063-6294a90aed002025-08-26WarningsExact identifier
application number: M020
Sun Bum Premium Sunscreen Face Stick Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC36dc7c13-eaf7-b415-e063-6294a90a57842025-08-26WarningsExact identifier
application number: M020
Sun Bum Face 50 Premium SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c1b7f0c-fdc2-df22-e063-6294a90aed412025-08-26WarningsExact identifier
application number: M020
Sun Bum Mist 45 Refreshing Sunscreen 3.4 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c1c8b83-f37d-a29d-e063-6294a90a20a82025-08-26WarningsExact identifier
application number: M020
Sun Bum 15 Premium Sunscreen Tanning OilAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c468710-ca71-79be-e063-6394a90a8cfd2025-08-26WarningsExact 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