FDA.reportPublic FDA data

Mineral Lip Sunscreen

Manufacturer
The Essential Brazilian Spa LLC | Custom Analytics LLC | Fragrance Manufactuing INC | Fallien Cosmeceuticals Ltd.
Effective date
2025-12-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:23:11

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-130385492212453GTIN-13: 0385492212453
EAN-13: 0385492212453
GTIN-12: 385492212453
UPC-A: 385492212453
GTIN storage (14 digits): 00385492212453		Brazil 212.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85492-212-45Mineral 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
85492-21285492-212-45
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
ALUMINALMI26O6933IACT
ASCORBYL PALMITATEQN83US2B0NIACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
PEG/PPG-15/15 DIMETHICONE184IZ28A2GIACT
CETYL DIMETHYLBUTYL ETHER7LAB1GXG9GIACT
PEG-8B697894SGQIACT
ZINC OXIDESOI2LOH54ZACTIB
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
ETHYLHEXYL PALMITATE2865993309IACT
HEXYLDECANOL151Z7P1317IACT
CETEARYL ISONONANOATEP5O01U99NIIACT
CI 774911K09F3G675IACT
CERESINQ1LS2UJO3AIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
STEARIC ACID4ELV7Z65APIACT
DIPROPYLENE GLYCOL CAPRATE/CAPRYLATE DIESTERR6G12EY23XIACT
CI 77499XM0M87F357IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
ZINGIBER OFFICINALE (GINGER) ROOT OILSAS9Z1SVUKIACT
CITRIC ACID2968PHW8QPIACT
TOCOPHEROLR0ZB2556P8IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ALUMINUM STEARATEU6XF9NP8HMIACT
PARASORBIC ACIDDCN48OUK3TIACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX42DG15CHXVIACT
SOYBEAN LECITHIN1DI56QDM62IACT
HEXYLDECYL LAURATE0V595C1P6MIACT
CI 77492EX438O2MRTIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC35442ac0-c361-e08f-e063-6294a90a5cb22025-12-15Exact identifier
ndc (package): 85492-212-45
ndc (product): 85492-212
ndc11 (package): 85492021245
spl id: 45ff88cb-2885-477a-e063-6294a90a9305
spl set id: 35442ac0-c361-e08f-e063-6294a90a5cb2
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC3bc8593d-fc6c-04aa-e063-6394a90a6d562025-12-15WarningsExact identifier
ndc (product): 85492-212
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.