FDA.reportPublic FDA data

Mineral Lip Sunscreen

Manufacturer
The Maui Medical Group, Inc | Fragrance Manufacturing Inc | Custom Analytics LLC
Effective date
2025-05-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:00:45

Label at a glance#

ProductMineral Lip Sunscreen
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product LabelProduct Label

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
85394-212-45Mineral Lip Sunscreen4.5 g in 1 CYLINDERSTICK4.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85394-212MINERAL LIP SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) STICK [THE MAUI MEDICAL GROUP, INC]1Current NDC, 1 package rows20250511_34b6aa46-657b-2676-e063-6294a90abadd.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85394-21285394-212-45

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
ASCORBIC ACIDPQ6CK8PD0RIACT
ASCORBYL PALMITATEQN83US2B0NIACT
CITRIC ACID2968PHW8QPIACT
DIPROPYLENE GLYCOL CAPRATE/CAPRYLATE DIESTERR6G12EY23XIACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX42DG15CHXVIACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
HEXYLDECANOL151Z7P1317IACT
CERESINQ1LS2UJO3AIACT
STEARIC ACID4ELV7Z65APIACT
ZINGIBER OFFICINALE (GINGER) ROOT OILSAS9Z1SVUKIACT
HEXYLDECYL LAURATE0V595C1P6MIACT
CI 77499XM0M87F357IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
ETHYLHEXYL PALMITATE2865993309IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
PEG-8B697894SGQIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALUMINALMI26O6933IACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
ALUMINUM STEARATEU6XF9NP8HMIACT
PEG/PPG-15/15 DIMETHICONE184IZ28A2GIACT
FLAVOR SPICE MINT N&A110589KG6KU384XWIACT
CI 774911K09F3G675IACT
CI 77492EX438O2MRTIACT
CETYL DIMETHYLBUTYL ETHER7LAB1GXG9GIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
TOCOPHEROLR0ZB2556P8IACT
CETEARYL ISONONANOATEP5O01U99NIIACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b6aa46-657b-2676-e063-6294a90abadd2025-05-09Exact identifier
ndc (package): 85394-212-45
ndc (product): 85394-212
ndc11 (package): 85394021245
spl id: 34b6aa46-657c-2676-e063-6294a90abadd
spl set id: 34b6aa46-657b-2676-e063-6294a90abadd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.