FDA.reportPublic FDA data

Mineral Lip Sunscreen

Manufacturer
HALEM DERMATOLOGY PLLC | Custom Analytics LLC | Fragrance Manufacturing Inc. | Fallien Cosmeceuticals Ltd.
Effective date
2025-12-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:21:56

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

Package LabelPackage Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130385413212456GTIN-13: 0385413212456
EAN-13: 0385413212456
GTIN-12: 385413212456
UPC-A: 385413212456
GTIN storage (14 digits): 00385413212456		HALEM 212.jpg

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
85413-212-45Mineral Lip Sunscreen1 in 1 CYLINDERSTICK12
85413-212-45Mineral Lip Sunscreen4.5 g in 1 CYLINDERSTICK4.52

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85413-21285413-212-45
58892-212

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

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

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEHALEM DERMATOLOGY PLLC35bce44e-d9f4-9279-e063-6394a90a64532025-12-11Exact identifier
ndc (package): 85413-212-45
ndc (product): 85413-212
ndc11 (package): 85413021245
spl id: 45b3b0ef-0939-2a47-e063-6294a90aea60
spl set id: 35bce44e-d9f4-9279-e063-6394a90a6453
PROCEUTICALS PRIVATE LABEL by TiZO mineral lip sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1d611494-648b-6e5f-e063-6294a90a45002024-07-16WarningsExact identifier
ndc (product): 58892-212

Reported adverse events (FAERS/openFDA)#

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