FDA.reportPublic FDA data

Comfort Mineral Mousse Sunscreen

Manufacturer
BIOHEALTH PLUS LLC | Custom Analytics LLC | Fragrance Manufacturing 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 01:23:28

Label at a glance#

ProductComfort Mineral Mousse 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-130385403211049GTIN-13: 0385403211049
EAN-13: 0385403211049
GTIN-12: 385403211049
UPC-A: 385403211049
GTIN storage (14 digits): 00385403211049		bio 211.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85403-211-04Comfort Mineral Mousse Sunscreen100 g in 1 CYLINDERAEROSOL, FOAM1002

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85403-21185403-211-04
58892-211

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
GLYCERYL STEARATE230OU9XXE4IACT
ISODODECANEA8289P68Y2IACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
CETEARYL ALCOHOL2DMT128M1SIACT
ZINC OXIDESOI2LOH54ZACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
CELLULOSE GUMK679OBS311IACT
CITRIC ACID2968PHW8QPIACT
GLYCERETH-26NNE56F2N14IACT
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
OCTYLDODECYL ERUCATED4N66T98C2IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
1,3,3,3-TETRAFLUOROPROPENE, (1E)-5I2481UOO8IACT
TRIACONTANYL PVPN0SS3Q238DIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
CAPRYLYL GLYCOL00YIU5438UIACT
POLYSORBATE 806OZP39ZG8HIACT
GLYCERINPDC6A3C0OXIACT
CETEARETH-20YRC528SWUYIACT
ISOHEXADECANE918X1OUF1EIACT

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
Comfort Mineral Mousse SunscreenTITANIUM DIOXIDE, ZINC OXIDEBIOHEALTH PLUS LLC3765dd17-ffbd-bcf4-e063-6394a90a2c2b2025-12-15Exact identifier
ndc (package): 85403-211-04
ndc (product): 85403-211
ndc11 (package): 85403021104
spl id: 4603cf13-1933-9811-e063-6294a90a613a
spl set id: 3765dd17-ffbd-bcf4-e063-6394a90a2c2b
Proceuticals Private Label by TiZO non-tinted foaming mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, Ltd1f4491ab-95b0-cc14-e063-6394a90a73ca2024-08-09WarningsExact identifier
ndc (product): 58892-211

Reported adverse events (FAERS/openFDA)#

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