FDA.reportPublic FDA data

spf 30 Lip Balm

Product NDC
53634-129
11-digit product format
536340129
Labeler code
53634
Product ID
53634-129_5d348531-6f3f-22fc-e063-6294a90a0986
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide
Dosage form
STICK
Route
TOPICAL
Labeler
Malin and Goetz Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-05-01
Substance
TITANIUM DIOXIDE
Active strength
3.3 g/100mL
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
spf 30 Lip Balm
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE3.3 g/100mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53634-129-01spf 30 Lip Balm10 mL in 1 TUBESTICK103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53634-129SPF 30 LIP BALM (TITANIUM DIOXIDE) STICK [MALIN AND GOETZ INC]2Current NDC, 1 package rows20241004_fe1b3122-b6e2-46fa-e053-6394a90afd59.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 171 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Reef Babies SPF 50 Oxybenzone FreeOCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.d5ed3488-aa32-4a63-9996-12c6532c3a4d2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30OCTOCRYLENE, OCTISALATE, AVOBENZONETropical Seas, Inc.b559499c-6109-bf5e-e053-2995a90a4ac72025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 50OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b5e24ca1-d041-355d-e053-2995a90a3d612025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b5570cbd-89f5-65d5-e053-2995a90a54d12025-11-04WarningsExact identifier
application number: M020
Land Shark Zinky SPF 36 Azure BlueZINC OXIDETropical Seas, Inc.d23fe61a-3ffb-59d0-e053-2995a90a59e62025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30OCTOCRYLENE, OCTISALATE, AVOBENZONETropical Seas, Inc.b55a0bd0-2a32-2977-e053-2a95a90aa1422025-11-04WarningsExact identifier
application number: M020
Expedition BackCountry SPF 30OCTOCRYLENE, OCTISALATE, AVOBENZONETropical Seas, Inc.06d43525-86d8-f2d9-e063-6394a90afc812025-11-04WarningsExact identifier
application number: M020
Land Shark Zinky SPF 36 Pacific PurpleZINC OXIDETropical Seas, Inc.d240fe7c-9d16-78c9-e053-2a95a90a763c2025-11-04WarningsExact identifier
application number: M020
Expedition BackCountry SPF 50OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.06c1ac52-474c-db5c-e063-6294a90afb5f2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30 Tinted ZincZINC OXIDE AND TITANIUM DIOXIDETropical Seas, Inc.d1287899-f178-6124-e053-2a95a90a95a52025-11-04WarningsExact identifier
application number: M020
Naked Sundays BeautyScreen Peptide Foundation TintZINC OXIDENaked Sundays1a623dfc-a8fc-858b-e063-6294a90a9c112025-11-04WarningsExact identifier
application number: M020
Odacite Mineral Drops Sheer SunscreenZINC OXIDEOdacite303f3af6-631a-57a8-e063-6294a90addda2025-11-04WarningsExact identifier
application number: M020
MedlineZINC OXIDEMedline Industries, LPcadba3bc-4a06-872a-e053-2995a90ab4472025-11-04WarningsExact identifier
application number: M020
Perricone MD Hypoallergenic CBD Sensitive Skin Therapy Ultra-Lightweight Calming SPF 35 VeilZINC OXIDETHG Beauty USA LLC2392c772-c251-1597-e063-6394a90a52f22025-11-03WarningsExact identifier
application number: M020
Hawaiian Tropic everyday Active Sport Sunscreen SPF50AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care LLCdc7d0757-c8a2-7fdb-e053-2a95a90a52822025-11-03WarningsExact identifier
application number: M020
MD Mineral BB Creme Broad Spectrum SPF 50 Water Resistant (80min) Mineral Sunscreen LIGHTTITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciencesa7f906f6-3041-4c24-955d-90cdd402dd022025-11-03WarningsExact identifier
application number: M020
Biopo Facial Mineral Sunscreen-Non Tinted SPF 40BIOPO FACIAL MINERAL SUNSCREEN-NON TINTED SPF 40Guangzhou Ariel Biotech Co., Ltd.42bc865f-29bd-da90-e063-6294a90aa16d2025-11-03WarningsExact identifier
application number: M020
Biopo Facial Mineral Sunscreen- Tinted SPF 40BIOPO FACIAL MINERAL SUNSCREEN- TINTED SPF 40Guangzhou Ariel Biotech Co., Ltd.42bd8bce-2959-266a-e063-6394a90a9a412025-11-03WarningsExact identifier
application number: M020
GoodSense SPF 30 SunscreenAVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%Geiss, Destin, & Dunn, Inc.c23c754a-9441-0a05-e053-2995a90afc552025-11-02WarningsExact identifier
application number: M020
SPF 30 Sport Sunscreen GoodSenseAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 8%Geiss, Destin, & Dunn, Inca22c6359-435d-626b-e053-2a95a90ae0c62025-11-02WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53634-129-015363401290110 mL in 1 TUBE (53634-129-01) 10 ml2023-05-01NoNoCurrent