FDA.reportPublic FDA data

Mineral Based Foam Sunscreen Non-Tinted

Manufacturer
KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION | Tri Pac, Inc. | Fallien Cosmeceuticals Ltd.
Effective date
2025-12-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:21:01

Label at a glance#

ProductMineral Based Foam Sunscreen Non-Tinted
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
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-130381679211011GTIN-13: 0381679211011
EAN-13: 0381679211011
GTIN-12: 381679211011
UPC-A: 381679211011
GTIN storage (14 digits): 00381679211011		Hutton 211.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81679-211-04Mineral Based Foam Sunscreen Non-Tinted100 g in 1 BOTTLE, DISPENSINGAEROSOL, 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
81679-21181679-211-04
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
CITRIC ACID2968PHW8QPIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GLYCERYL STEARATE230OU9XXE4IACT
ISODODECANEA8289P68Y2IACT
ISOHEXADECANE918X1OUF1EIACT
CAPRYLYL GLYCOL00YIU5438UIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
POLYSORBATE 806OZP39ZG8HIACT
1,3,3,3-TETRAFLUOROPROPENE, (1E)-5I2481UOO8IACT
GLYCERETH-26NNE56F2N14IACT
GLYCERINPDC6A3C0OXIACT
OCTYLDODECYL ERUCATED4N66T98C2IACT
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11IACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
CELLULOSE GUMK679OBS311IACT
CETEARETH-20YRC528SWUYIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ZINC OXIDESOI2LOH54ZACTIB
CETEARYL ALCOHOL2DMT128M1SIACT
WATER059QF0KO0RIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
TRIACONTANYL PVPN0SS3Q238DIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT

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 Based Foam Sunscreen Non-TintedTITANIUM DIOXIDE, ZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION32486bfb-0cc8-0283-e063-6394a90a99672025-12-08Exact identifier
ndc (package): 81679-211-04
ndc (product): 81679-211
ndc11 (package): 81679021104
spl id: 457579a1-1b01-7cd4-e063-6294a90a2225
spl set id: 32486bfb-0cc8-0283-e063-6394a90a9967
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.