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 193 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sun Bum Kids 50 Clear SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c1f619e-dd4e-ab62-e063-6294a90a10d42025-08-22WarningsExact identifier
application number: M020
Sun Bum Premium Moisturizing Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3cf8c55b-5203-3a96-e063-6294a90a4e9e2025-08-22WarningsExact identifier
application number: M020
Baby Bum Mineral 50 SunscreenZINC OXIDESun Bum LLC369f449f-fb9d-5529-e063-6394a90ac3b22025-08-22WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 4ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3cdc1ae9-2924-5057-e063-6294a90ad2f32025-08-21WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 3ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3b21f1d8-534d-f4ea-e063-6294a90ad2eb2025-08-21WarningsExact identifier
application number: M020
LBEL CONCENTRE GLOBAL ANTI AGING SERUM FOUNDATION SPF 15 ALMENDRA 230NOCTINOXATE, ZINC OXIDEBEL STAR S.A.2cb3cd01-8871-59a0-e063-6394a90ac0f72025-08-21WarningsExact identifier
application number: M020
Neutrogena Triple Age Repair Moisturizer with Sunscreen Broad Spectrum SPF 25AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCa6011835-cd2f-476f-9ec1-721f896483c52025-08-21WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC35fc2571-370c-42aa-986c-b1fa58658d862025-08-21WarningsExact identifier
application number: M020
Sun Bum 50 Sunscreen Face StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3ce436e8-bc22-b9d7-e063-6394a90a57c42025-08-21WarningsExact identifier
application number: M020
CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 FUCHSIA CREAMYOCTINOXATE, ZINC OXIDEBEL STAR S Aea39a1c0-6b12-77ba-e053-2995a90a73142025-08-21WarningsExact identifier
application number: M020
Neutrogena Clear Face Breakout Free Oil Free Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCcd211d06-b91e-44b1-99fe-fa0794f102212025-08-21WarningsExact identifier
application number: M020
Sun Bum Sunscreen Lip Balm Broad Spectrum SPF 30 KiwiAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3cd51497-693e-bf79-e063-6394a90a5e482025-08-21WarningsExact identifier
application number: M020
LBEL SOLUTIONS PRO-NUDE SKIN ULTRA-LIGHT SERUM FOUNDATION WITH NIACINAMIDE SPF 20 CHAMPAGNE 170NOCTINOXATE, ZINC OXIDEBEL STAR S.A.2f769ed5-0176-8c80-e063-6394a90a92c62025-08-21WarningsExact identifier
application number: M020
Sun Bum 30 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC21caf385-f11b-146a-e063-6294a90aa8512025-08-21WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC3ce6d119-5e3e-dfa4-e063-6394a90a474b2025-08-21WarningsExact identifier
application number: M020
Sun Bum 50 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC21cb8652-c6d0-0a77-e063-6294a90a6e1e2025-08-21WarningsExact identifier
application number: M020
Sun Bum Signature High Performance Mineral Sunscreen Face Stick 30ZINC OXIDESun Bum, LLC3ce81478-196e-d87b-e063-6294a90afd582025-08-21WarningsExact identifier
application number: M020
Premium Moisturizing Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC33164cea-e31e-9fcc-e063-6294a90a307e2025-08-21WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 5ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3ceb3368-439c-9f6c-e063-6294a90a98ba2025-08-21WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 2ENSULIZOLE ,HOMOSALATE ,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3cc8b151-c07d-7473-e063-6294a90a1cc72025-08-20WarningsExact 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