FDA.reportPublic FDA data

Ware Sonny Universal

Manufacturer
Ware Cosmetics
Effective date
2025-11-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:16:18

Label at a glance#

ProductWare Sonny Universal
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure8 sections

Label contents#

Full prescribing information#

Ware Sonny Universal

DOSAGE & ADMINISTRATION SECTION

dosage & Administrationdosage & Administration

Ware Sonny Universal

INACTIVE INGREDIENT SECTION

Inactive ingredientsInactive ingredients

Ware Sonny Universal

INDICATIONS & USAGE SECTION

Indications & usageIndications & usage

Ware Sonny Universal

OTC - ACTIVE INGREDIENT SECTION

Active IngredientsActive Ingredients

Ware Sonny Universal

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of childrenkeep out of reach of children

Ware Sonny Universal

OTC - PURPOSE SECTION

purposepurpose

Ware Sonny Universal

WARNINGS SECTION

Warning LabelWarning Label

Ware Sonny Universal

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83510-400-01Ware Sonny Universal30 mL in 1 BOTTLE, PUMPLOTION304
83510-400-02Ware Sonny Universal1 in 1 CARTONLOTION14

Products#

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

DailyMed product names page 1 of 2 · 41 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83510-40083510-400-01, 83510-400-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW)9KB5R958PBIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ETHYLHEXYL ISONONANOATEI6KB4GE3K4IACT
CETETH-20I835H2IHHXIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
TOCOPHEROLR0ZB2556P8IACT
RUTTNERA LAMELLOSA OIL5XZ38R4SUTIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERRIC OXIDE RED1K09F3G675IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
POLYESTER-70841698D2FIACT
GLYCERINPDC6A3C0OXIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
ALLANTOIN344S277G0ZIACT
CAPRYLYL GLYCOL00YIU5438UIACT
AVENA SATIVA WHOLE5P8D0Z74RGIACT
DICRATERIA ROTUNDA OILZ0DWU9R4GMIACT
DISODIUM EDTA-COPPER6V475AX06UIACT
CAMELLIA SINENSIS WHOLEC5M4585ZBZIACT
TRICETEARETH-4 PHOSPHATE69534Y66NOIACT
PULLULAN8ZQ0AYU1TTIACT
XANTHAN GUMTTV12P4NEEIACT
STEARETH-20L0Q8IK9E08IACT
HEXYLENE GLYCOLKEH0A3F75JIACT
TRILAURETH-4 PHOSPHATEM96W2OLL2VIACT
SODIUM ASCORBATES033EH8359IACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
CETYL ALCOHOL936JST6JCNIACT
SQUALANEGW89575KF9IACT
PEG-75 STEARATEOT38R0N74HIACT
PHENOXYETHANOLHIE492ZZ3TIACT
.ALPHA.-BISABOLOL, (+)-105S6I733ZIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ZINC OXIDESOI2LOH54ZACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ware Sonny UniversalTITANIUM DIOXIDE, ZINC OXIDEWare Cosmeticsfe2b9d16-9215-e21e-e053-6394a90a51562025-11-14WarningsExact identifier
ndc (package): 83510-400-01
ndc (package): 83510-400-02
ndc (product): 83510-400
ndc11 (package): 83510040001
ndc11 (package): 83510040002
spl id: 43906087-7f16-b1d1-e063-6294a90a7395
spl set id: fe2b9d16-9215-e21e-e053-6394a90a5156

Reported adverse events (FAERS/openFDA)#

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