FDA.reportPublic FDA data

Non-Tinted Mineral Foaming Sunscreen

Manufacturer
Restore Skin Therapy, LLC | Custom Analytics LLC | Fragrance Manufacturing Inc | Fallien Cosmeceuticals Ltd.
Effective date
2025-12-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:21:57

Label at a glance#

ProductNon-Tinted Mineral Foaming Sunscreen
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product LabelProduct Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85313-211-04Non-Tinted Mineral Foaming Sunscreen113 g in 1 BOTTLE, PUMPAEROSOL, FOAM1132

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
85313-21185313-211-04
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
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GLYCERETH-26NNE56F2N14IACT
OCTYLDODECYL ERUCATED4N66T98C2IACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
TRIACONTANYL PVPN0SS3Q238DIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
1,3,3,3-TETRAFLUOROPROPENE, (1E)-5I2481UOO8IACT
GLYCERINPDC6A3C0OXIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
POLYSORBATE 806OZP39ZG8HIACT
WATER059QF0KO0RIACT
CETEARYL ALCOHOL2DMT128M1SIACT
GLYCERYL STEARATE230OU9XXE4IACT
CAPRYLYL GLYCOL00YIU5438UIACT
CELLULOSE GUMK679OBS311IACT
ISODODECANEA8289P68Y2IACT
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11IACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
CETEARETH-20YRC528SWUYIACT
ZINC OXIDESOI2LOH54ZACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
CITRIC ACID2968PHW8QPIACT
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
Non-Tinted Mineral Foaming SunscreenTITANIUM DIOXIDE, ZINC OXIDERestore Skin Therapy, LLC364b6af2-a0ed-4a17-e063-6394a90a3a172025-12-10Exact identifier
ndc (package): 85313-211-04
ndc (product): 85313-211
ndc11 (package): 85313021104
spl id: 459bfcc2-12be-82a9-e063-6294a90a6ca3
spl set id: 364b6af2-a0ed-4a17-e063-6394a90a3a17
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.