FDA.reportPublic FDA data

AVONBENZONE 3%

Manufacturer
Grace and Fire USA Inc.
Effective date
2026-06-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-06-04 05:10:17

Label at a glance#

ProductUltra Violette Preen Screen Broad Spectrum SPF 50
Active ingredientOCTISALATE, OCTOCRYLENE, HOMOSALATE, AVOBENZONE
Label structure2 sections

Label contents#

Full prescribing information#

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - DO NOT USE SECTION

Keep out of eyes. Rinse with water to remove

OTC - WHEN USING SECTION

Stop use and ask a doctor if rash occurs

OTC - STOP USE SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ultra Violette

Preen Screen Broad Spectrum SPF 50 Reapplication Mist Skinscreen

1.7 FL. OZ. (50 mL) 1 FL. OZ (30mL) Preen_ScreenPreen_Screen Preen_ScreenPreen_Screen

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84803-10184803-101-50, 84803-101-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ISODODECANEA8289P68Y2IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SODIUM HYALURONATEYSE9PPT4THIACT
BENZYL SALICYLATEWAO5MNK9TUIACT
LINALOOL, (-)-3U21E3V8I2IACT
CAMELLIA SINENSIS LEAF OILVC855RRT77IACT
HELIANTHUS ANNUUS (SUNFLOWER) SEEDR9N3379M4ZIACT
BISABOLOL24WE03BX2TIACT
GLYCINE SOJA (SOYBEAN) OIL UNSAPONIFIABLESWZ7DY7GBV6IACT
ETHYLHEXYL PALMITATE2865993309IACT
CAPRYLYL GLYCOL00YIU5438UIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
ALOE BARBADENSIS LEAFZY81Z83H0XIACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT
ASCORBYL TETRAISOPALMITATE47143LT58AIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
HEXYL CINNAMAL7X6O37OK2IIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
NIACINAMIDE25X51I8RD4IACT
ACRYLATES/OCTYLACRYLAMIDE COPOLYMER (40000 MW)7LL6SY9YFVIACT
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
HOMOSALATEV06SV4M95SACTIB
AVOBENZONEG63QQF2NOXACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-01-05full-release2026-06-01 01:31:12

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
Ultra Violette Preen Screen Broad Spectrum SPF 50AVONBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEGrace and Fire USA Inc.26a0fc0d-a903-2ac1-e063-6394a90a13db2026-06-01WarningsExact identifier
ndc (package): 84803-101-30
ndc (package): 84803-101-50
ndc (product): 84803-101
ndc11 (package): 84803010150
ndc11 (package): 84803010130
spl id: 533cb134-43ee-e843-e063-6294a90a38a1
spl set id: 26a0fc0d-a903-2ac1-e063-6394a90a13db
ULTRA VIOLETTE SPF ON THE GLOW Duo Pack KitSPF 50Grace And Fire USA Inc.47b7da8a-ea89-1402-e063-6294a90a23f92026-01-06WarningsExact identifier
ndc (package): 84803-101-30
ndc11 (package): 84803010130

Reported adverse events (FAERS/openFDA)#

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