Home NDC 84803-116 ULTRA VIOLETTE Unblock Screen SPF 50 Sunscreen
Product NDC 84803-116
11-digit product format 848030116
Labeler code 84803
Product ID 84803-116_56ad0dce-410f-9d78-e063-6294a90a1c3e
Type HUMAN OTC DRUG
Nonproprietary name bemotrizinol, octocrylene, zinc oxide
Dosage form CREAM
Route TOPICAL
Labeler Grace and Fire USA Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-08-09
Substance BEMOTRIZINOL; OCTOCRYLENE; ZINC OXIDE
Active strength .3; .6; 1 g/10mL; g/10mL; g/10mL
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 Unblock Screen SPF 50 Sunscreen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BEMOTRIZINOL .3 g/10mL OCTOCRYLENE .6 g/10mL ZINC OXIDE 1 g/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination PWZ1720CBH Internal UNII lookup 5A68WGF6WM Internal UNII lookup SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 26 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 84803-116-05 84803011605 1 TUBE in 1 CARTON (84803-116-05) / 5 mL in 1 TUBE 1 tube 2026-08-09 No No Current 84803-116-50 84803011650 1 JAR in 1 CARTON (84803-116-50) / 50 mL in 1 JAR 1 jar 2026-08-09 No No Current