FDA.reportPublic FDA data

Advanced Lip Guard

Product NDC
85351-212
11-digit product format
853510212
Labeler code
85351
Product ID
85351-212_4586c0c2-5a4a-1dfd-e063-6294a90a79ff
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
STICK
Route
TOPICAL
Labeler
ADVANCED DERMATOLOGY
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-05-01
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
Advanced Lip Guard
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
32e66ff3-ae1a-4a2a-e063-6294a90a7963Available 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
85351-212-45Advanced Lip Guard4.5 g in 1 CYLINDERSTICK4.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85351-212ADVANCED LIP GUARD (TITANIUM DIOXIDE, ZINC OXIDE) STICK [ADVANCED DERMATOLOGY]1Current NDC, 1 package rows20250418_32e66ff3-ae1a-4a2a-e063-6294a90a7963.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 135 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUNerchi Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESYNERCHI MED SPA, INC.37db5721-2b32-d4d8-e063-6294a90a47d72025-12-11Exact identifier
application number: M020
SUNerchi Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESYNERCHI MED SPA, INC.37db14e1-f995-b649-e063-6294a90afd692025-12-11Exact identifier
application number: M020
208ZINC OXIDEPETER L. KOPELSON, M.D.351ce033-6bd0-574e-e063-6394a90af4482025-12-11Exact identifier
application number: M020
208ZINC OXIDEPETER L. KOPELSON, M.D.,351c9727-d7ac-9c3f-e063-6294a90a77212025-12-11Exact identifier
application number: M020
Replenishing Daily Protection TintedZINC OXIDEMY FAVORITE PLACE SPA LLC351c0c1e-5712-1e23-e063-6394a90abe6f2025-12-11Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESaving Face Skinspa Inc.351d27e3-00d4-8d31-e063-6394a90aaf722025-12-11Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESaving Face Skinspa Inc.351db99e-262f-b67e-e063-6394a90a34182025-12-11Exact identifier
application number: M020
Replenishing Daily Protection NTZINC OXIDEMY FAVORITE PLACE SPA LLC351c5f6f-86e6-7219-e063-6294a90a37452025-12-11Exact identifier
application number: M020
Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEDAISY'S SKIN TRANSFORMATION LLC37d9fbf5-d602-d3dc-e063-6394a90abe532025-12-11Exact identifier
application number: M020
Tinted Mineral 40TITANIUM DIOXIDE, ZINC OXIDE2301 PLASTIC SURGERY, PLLC374d53a7-be0b-4d7a-e063-6394a90a37c42025-12-11Exact identifier
application number: M020
Daily Protection 40ZINC OXIDE2301 PLASTIC SURGERY, PLLC374d9c77-ed9f-a518-e063-6394a90a34fa2025-12-11Exact identifier
application number: M020
Tinted Mineral 40TITANIUM DIOXIDE, ZINC OXIDE2301 PLASTIC SURGERY, PLLC374df66d-eb9b-c4a7-e063-6394a90a3cc62025-12-11Exact identifier
application number: M020
Daily Protection 40ZINC OXIDE2301 PLASTIC SURGERY, PLLC374e2294-7281-c7b9-e063-6394a90acc892025-12-11Exact identifier
application number: M020
Facial Mineral Sunscreen Mineral ProtectionTITANIUM DIOXIDE, ZINC OXIDECAPE COD SKIN CARE CO. INC.387f6dd5-3901-0849-e063-6294a90af8bc2025-12-11Exact identifier
application number: M020
Non - Tinted Mineral SunscreenZINC OXIDENEXTEX CORPORATION35bacfcf-0254-aa0a-e063-6394a90a14752025-12-11Exact identifier
application number: M020
Facial Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELEDUC, XUANTO MD387e2e59-c5db-c70e-e063-6394a90a2d262025-12-11Exact identifier
application number: M020
Facial Mineral Sunscreen Mineral ProtectionTITANIUM DIOXIDE, ZINC OXIDECAPE COD SKIN CARE CO. INC.390779a8-4556-27a5-e063-6294a90a12002025-12-11Exact identifier
application number: M020
non-tinted sheer matte mineralTITANIUM DIOXIDE, ZINC OXIDENEXTEX CORPORATION35ba6cc9-0d49-6d0c-e063-6394a90ac7c32025-12-11Exact identifier
application number: M020
sheer tinted matte mineralTITANIUM DIOXIDE, ZINC OXIDENEXTEX CORPORATION35ba9ca7-fe5c-9824-e063-6394a90a5c462025-12-11Exact identifier
application number: M020
illuminating mineral mousseTITANIUM DIOXIDE, ZINC OXIDENEXTEX CORPORATION35bb4d67-373f-f60c-e063-6394a90a974d2025-12-11Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85351-212-45853510212454.5 g in 1 CYLINDER (85351-212-45) 4.5 g2019-05-01NoNoCurrent