Ultra Violette Preen Screen Broad Spectrum SPF 50

Product NDC
84803-101
11-digit product format
848030101
Labeler code
84803
Product ID
84803-101_533cb134-43ee-e843-e063-6294a90a38a1
Type
HUMAN OTC DRUG
Nonproprietary name
AVONBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE
Dosage form
SPRAY
Route
TOPICAL
Labeler
Grace and Fire USA Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-01
Substance
OCTISALATE; OCTOCRYLENE; HOMOSALATE; AVOBENZONE
Active strength
50; 60; 100; 30 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Ultra Violette Preen Screen Broad Spectrum SPF 50
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE50 mg/mL
OCTOCRYLENE60 mg/mL
HOMOSALATE100 mg/mL
AVOBENZONE30 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup
V06SV4M95SInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
26a0fc0d-a903-2ac1-e063-6394a90a13dbAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84803-101-30ULTRA VIOLETTE SPF ON THE GLOWDuo Pack Kit30 mL in 1 BOTTLE, SPRAYSPRAY1 mL in 3030 mg in 1mL4
84803-101-30Ultra Violette Preen Screen Broad Spectrum SPF 5030 mL in 1 BOTTLE, SPRAYSPRAY302
84803-101-50Ultra Violette Preen Screen Broad Spectrum SPF 5050 mL in 1 BOTTLE, SPRAYSPRAY502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84803-101ULTRA VIOLETTE PREEN SCREEN BROAD SPECTRUM SPF 50 (AVONBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) SPRAY [GRACE AND FIRE USA INC.]1Current NDC, 2 package rows20241202_26a0fc0d-a903-2ac1-e063-6394a90a13db.zip

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 269 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coral Care SPF 30 SunscreenTITANIUM DIOXIDE 8.8%Stream2Sea2749fa0e-aed5-6c9a-e063-6294a90a2bf12024-11-19WarningsExact identifier
application number: M020
FULL SPECTRUM MATTE AMBITION SKIN PRIMER SPF 20ENSULIZOLENoxell Corporation82f7bff9-718e-19ea-e053-2991aa0a35602024-11-19WarningsExact identifier
application number: M020
Rimmel London Lasting Finish 25 HR Foundation SPF 20OCTINOXATERimmelcfd041e9-ed40-dc93-e053-2995a90a96992024-11-19WarningsExact identifier
application number: M020
ultimate miracle worker multi-rejuvenating spf 30AVOBENZONE, OCTINOXATE, OCTOCRYLENEPhilosophy, Inc.4387abab-ee1c-4e93-bea9-01624e8b48322024-11-19WarningsExact identifier
application number: M020
Sun Voyage KitAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEKoco Life LLC2732a8d2-6f56-c088-e063-6294a90af3082024-11-18WarningsExact identifier
application number: M020
Eminence Radiant Protection SPF FluidZINC OXIDEEminence Organic Skin Care002a4766-0c7e-4ec7-e063-6294a90a78d82024-11-18WarningsExact identifier
application number: M020
Eryfotona Actinica Ultralight EmulsionSUNSCREENISDIN Corp1d4b88d3-bee9-102c-e054-00144ff8d46c2024-11-18WarningsExact identifier
application number: M020
Rodan and Fields Plumping Lip SPF 28 SunscreenOCTINOXATE, ZINC OXIDERodan & Fieldsedf05ccc-4299-48d5-8f8e-01255eca11c22024-11-15WarningsExact identifier
application number: M020
Melan Mineral Antioxidant Body Mist Mineral Sunscreen SPF 30ZINC OXIDEMELAN INC.210823a0-94f9-4833-b279-fc26b90611952024-11-14WarningsExact identifier
application number: M020
Luminous Sunscreen SPF 50ZINC OXIDE, TITANIUM DIOXIDECLINICAL SKIN LLC26e2b82c-8d7a-7261-e063-6394a90a7c0d2024-11-14WarningsExact identifier
application number: M020
CoTZ Flawless ComplexionZINC OXIDEFallien Cosmeceuticals, LTD0973223b-e75f-4eb8-bcf1-7931b30b7b512024-11-14WarningsExact identifier
application number: M020
TiZO Photoceutical Environmental Skin ProtectantDIMETHICONEFallien Cosmeceuticals, LTD84a3299d-9b98-492e-a83f-ebd72ec58f8d2024-11-14WarningsExact identifier
application number: M020
TiZO Photoceutical AM Replenish Non-TintedZINC OXIDEFallien Cosmeceuticals, LTDc52a1e04-f3ca-47a1-a26e-d6f5e77b47d62024-11-14WarningsExact identifier
application number: M020
Neutrogena MINERAL UV TINT FACE LIGHT SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLCe7af4f58-90c8-2987-e053-2995a90a416b2024-11-13WarningsExact identifier
application number: M020
Neutrogena Healthy Skin Liquid Makeup Broad Spectrum SPF 20 - Classic Ivory 10TITANIUM DIOXIDEKenvue Brands LLC143e0a1d-305f-9015-e063-6294a90aa0252024-11-13WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC05cb5a91-205f-b652-e063-6294a90a06642024-11-13WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Dry-Touch Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC18e40353-5c95-4d64-e063-6394a90a017c2024-11-12WarningsExact identifier
application number: M020
Neutrogena Healthy Skin Liquid Makeup SPF 20 - Classic Ivory 10TITANIUM DIOXIDEKenvue Brands LLCe0ed4537-8146-45e8-e053-2995a90ac51b2024-11-12WarningsExact identifier
application number: M020
Arbonne AgeWell Moisture Restoring Broad Spectrum SPF 15 SunscreenZINC OXIDEArbonne International, LLCc172f793-3f7a-47b3-9db1-58487b8ad66c2024-11-12WarningsExact identifier
application number: M020
Hello Sunday The Everyday One Face Moisturiser SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKao USA Inc.0c7e1aa2-7054-435d-e063-6394a90a2d082024-11-12WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84803-101-308480301013030 mL in 1 BOTTLE, SPRAY (84803-101-30) 30 ml2024-12-01NoNoCurrent
84803-101-508480301015050 mL in 1 BOTTLE, SPRAY (84803-101-50) 50 ml2024-12-01NoNoCurrent