Home NDC 84803-101 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 Ingredient Strength OCTISALATE 50 mg/mL OCTOCRYLENE 60 mg/mL HOMOSALATE 100 mg/mL AVOBENZONE 30 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84803-101-30 ULTRA VIOLETTE SPF ON THE GLOWDuo Pack Kit 30 mL in 1 BOTTLE, SPRAY SPRAY 1 mL in 30 30 mg in 1mL 4 84803-101-30 Ultra Violette Preen Screen Broad Spectrum SPF 50 30 mL in 1 BOTTLE, SPRAY SPRAY 30 2 84803-101-50 Ultra Violette Preen Screen Broad Spectrum SPF 50 50 mL in 1 BOTTLE, SPRAY SPRAY 50 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84803-101 ULTRA VIOLETTE PREEN SCREEN BROAD SPECTRUM SPF 50 (AVONBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) SPRAY [GRACE AND FIRE USA INC.] 1 Current NDC, 2 package rows 20241202_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 45 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84803-101-30 84803010130 30 mL in 1 BOTTLE, SPRAY (84803-101-30) 30 ml 2024-12-01 No No Current 84803-101-50 84803010150 50 mL in 1 BOTTLE, SPRAY (84803-101-50) 50 ml 2024-12-01 No No Current