Home NDC 87482-001 PRVWORA Ultra Defense Sunscreen
Product NDC 87482-001
11-digit product format 874820001
Labeler code 87482
Product ID 87482-001_4e9f781d-6b07-b69a-e063-6394a90a36c8
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Octinoxate, Octisalate, Octocrylene
Dosage form CREAM
Route TOPICAL
Labeler Cellarkbio Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-04-04
Substance OCTINOXATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE
Active strength 72.5; 45; 95; 28.5 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 PRVWORA Ultra Defense Sunscreen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTINOXATE 72.5 mg/mL OCTISALATE 45 mg/mL OCTOCRYLENE 95 mg/mL AVOBENZONE 28.5 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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 87482-001-01 PRVWORA Ultra Defense Sunscreen 50 mL in 1 TUBE CREAM 50 1 87482-001-02 PRVWORA Ultra Defense Sunscreen 1 in 1 CARTON CREAM 1 1
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 162 of 353 · 7,049 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 87482-001-01 87482000101 50 mL in 1 TUBE 50 ml Historical 87482-001-02 87482000102 1 TUBE in 1 CARTON (87482-001-02) / 50 mL in 1 TUBE (87482-001-01) 1 tube 2026-04-04 No No Current