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 218 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermatone SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDermatone Labs LLC32e5bddf-a0b5-c511-e063-6294a90aaf662025-04-16WarningsExact identifier
application number: M020
Sunscreen Lip Balm SPF 30 Cool MintAVOBENZONE 3%, HOMOSALATE 7%, OCTISALATE 4.5%, OCTOCRYLENE 9%USRX3271ab14-3bf5-a24f-e063-6294a90a59bc2025-04-16WarningsExact identifier
application number: M020
goodal GREEN TANGERINE VITA C DARK SPOT UV DEFENSE SUNSCREEN SPF50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONECLIO COSMETICS Co., Ltd.77a0d190-f558-474b-89d2-c79b37c50c0d2025-04-16WarningsExact identifier
application number: M020
Brush On Block SPF 30 Mineral Powder Touch of Tan Zinc Only - REFILLZINC OXIDESPF Ventures, LLC32ccb93a-50cf-f436-e063-6294a90a24922025-04-15WarningsExact identifier
application number: M020
DECORTE SUN SHELTER MULTI PROTECTION Sunscreen SPF 50 Broad SpectrumAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATEKOS America, Inc.2b41c17d-1394-0c2f-e063-6394a90a0c492025-04-15WarningsExact identifier
application number: M020
Urban Antioxidant Sunscreen SPF 40HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXYIDE CREAMDr. Loretta, LLC930150a3-08bb-17fd-e053-2995a90a786b2025-04-15WarningsExact identifier
application number: M020
Cicapair Soothing Color Correcting Treatment Cica Complex Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEHave & Be Co., Ltd.32c1aba6-5e29-aba9-e063-6394a90a8e562025-04-14WarningsExact identifier
application number: M020
REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRYOCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDECLINIQUE LABORATORIES LLC07701e11-8a7e-44c5-b46e-5b48264eacad2025-04-14WarningsExact identifier
application number: M020
Dr.Ceuracle HYDRA BARRIER SUNSCREENZINC OXIDELeegeehaam Cosmetics22c05215-4983-b32e-e063-6394a90a9f672025-04-13WarningsExact identifier
application number: M020
No7 Protect and Perfect Intense Advanced Day Cream SPF 30AVOBENZONE,OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS3285e28d-5716-b576-e063-6294a90a89052025-04-11WarningsExact identifier
application number: M020
No7 Protect and Perfect Intense Advanced Fragrance Free Day Cream SPF 30AVOBENZONE,OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS32876315-f81f-fdd2-e063-6394a90ad5f72025-04-11WarningsExact identifier
application number: M020
No7 Future Renew Damage Reversal Day Cream Sunscreen Broad Spectrum SPF 25AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS3287ae2e-759e-31c5-e063-6394a90a892f2025-04-11WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Fragrance Free Day Cream SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS32b5a19e-86d4-5ee1-e063-6394a90a12e22025-04-11WarningsExact identifier
application number: M020
LERINN ZINCPURE SUNMILK SPF 50ZINC OXIDESerrina Lin Skincare Inc32717b49-729c-a229-e063-6394a90a18fb2025-04-10WarningsExact identifier
application number: M020
Smoothing Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEDANIEL BEHROOZAN MD A MEDICAL CORPORATION327246c2-9d7a-2d34-e063-6294a90a5fb72025-04-10Exact identifier
application number: M020
Clarity Rx Physical Skin Defense SPF 50ZINC OXIDE AND TITANIUM DIOXIDETopiderm, Inc.b5111012-97b9-4908-95a0-d09595f9c4d92025-04-10WarningsExact identifier
application number: M020
Tinted Mineral Sunscreen SPF 50ZINC OXIDE AND TITANIUM DIOXIDETopiderm, Inc.13e5085f-df2b-46b2-b063-e58ce43799052025-04-09WarningsExact identifier
application number: M020
Sunstation Sport Sunscreen SPF 30OCTOCRYLENE, ZINC OXIDE, OCTISALATESunstation USA LLC6007c125-f28a-45e5-b8f1-490ee04b78112025-04-09WarningsExact identifier
application number: M020
Pacifica Sun Dreams Illuminating SPF FoamHOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEPacifica Beauty, LLC2e0cb105-75c3-8032-e063-6394a90ab5022025-04-09WarningsExact identifier
application number: M020
belif Aqua bomb - glow sunstick SPF50HOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANELG H&H CO., LTD.284cadf1-deb9-4f3d-e063-6394a90ab1222025-04-09WarningsExact 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