FDA.reportPublic FDA data

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 335 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Broad Spectrum SPF 30 Sun StickBROAD SPECTRUM SPF 30 SUN STICKRaining Rose, Inca35a7973-443b-5247-e053-2a95a90a44592023-10-23WarningsExact identifier
application number: M020
Cranberry Orange SPF 15 Broad Spectrum Lip BalmCRANBERRY ORANGE SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca8c3aa41-c9a0-4f64-e053-2995a90a005e2023-10-23WarningsExact identifier
application number: M020
Super Mint SPF 15 Broad Spectrum Lip BalmSUPER MINT SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca9626a2f-9931-78d2-e053-2995a90ac40f2023-10-23WarningsExact identifier
application number: M020
Spearmint SPF 30 Broad Spectrum Lip BalmSPEARMINT SPF 30 BROAD SPECTRUM LIP BALMRaining Rose, Incb7b520dc-bae6-614f-e053-2995a90ae6772023-10-23WarningsExact identifier
application number: M020
Citrus SPF 15 Broad Spectrum Lip BalmCITRUS SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca75d0651-6001-29ce-e053-2a95a90a967f2023-10-23WarningsExact identifier
application number: M020
Coconut Mineral SPF 15 Broad Spectrum Lip BalmCOCONUT MINERAL SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Incb7b542fa-b0d2-7b33-e053-2995a90a71192023-10-23WarningsExact identifier
application number: M020
Vanilla SPF 30 Broad Spectrum Lip BalmVANILLA SPF 30 BROAD SPECTRUM LIP BALMRaining Rose, Incb7b542fa-b0c2-7b33-e053-2995a90a71192023-10-23WarningsExact identifier
application number: M020
Pineapple Mineral SPF 15 Broad Spectrum Lip BalmPINEAPPLE MINERAL SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Incb7c6684f-1122-20c1-e053-2995a90ae6cf2023-10-23WarningsExact identifier
application number: M020
Farmasi CC Cream LIGHT to MEDIUM 02TITANIUM DIOXIDETAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI28b3fdff-1986-4048-9ed5-a3d784a4014e2023-10-23WarningsExact identifier
application number: M020
Farmasi CC Cream- MEDIUM 03TITANIUM DIOXIDETAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI65de3c45-8ec2-4d73-8a29-6203d3b47bd72023-10-23WarningsExact identifier
application number: M020
Farmasi BB Cream- MEDIUM 03TITANIUM DIOXIDETAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI9102aa2f-0308-4985-b8a8-8e105047b61f2023-10-23WarningsExact identifier
application number: M020
Caribbean Breeze SPF 15 Broad Spectrum Lip BalmCARIBBEAN BREEZE SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca75a42f6-27d1-e2cc-e053-2a95a90aa6da2023-10-23WarningsExact identifier
application number: M020
Iced Pear SPF 15 Broad Spectrum Lip BalmICED PEAR SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca8c4a0ec-e07e-1cda-e053-2a95a90a0f3f2023-10-23WarningsExact identifier
application number: M020
Lemonade SPF 15 Broad Spectrum Lip BalmLEMONADE SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca8ffc32b-b758-0f8f-e053-2995a90adb622023-10-23WarningsExact identifier
application number: M020
Strawberry SPF 15 Broad Spectrum Lip BalmSTRAWBERRY SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca902d590-0726-ad6f-e053-2995a90a11302023-10-23WarningsExact identifier
application number: M020
Orange Creamsicle SPF 15 Broad Spectrum Lip BalmORANGE CREAMSICLE SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca9005cb1-ae1a-7736-e053-2995a90a28ea2023-10-23WarningsExact identifier
application number: M020
Neora Age IQ Invisi-Bloc SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENeora, LLCf2f3601f-081a-4bae-e053-2a95a90a4fac2023-10-23WarningsExact identifier
application number: M020
Neora Age IQ Invisi-Bloc SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENeora, LLC82f48635-1dc4-8c0d-e053-2991aa0a60cc2023-10-23WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Golden L4N1TITANIUM DIOXIDEAmway Corp7494fe09-40e0-4152-9974-a6e8a4d7f4212023-10-22WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Soleil L3W1TITANIUM DIOXIDEAmway Corpcec51b88-a6b8-4b64-b3aa-830e712a3c8a2023-10-22WarningsExact 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