Home NDC 85791-4531 Sunsei SPF 45 Sunscreen
Product NDC 85791-4531
11-digit product format 857914531
Labeler code 85791
Product ID 85791-4531_4c9e0316-7c08-d8a8-e063-6294a90a895b
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form LIQUID
Route TOPICAL
Labeler Shimoda Prime Products, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-03-15
Substance ZINC OXIDE
Active strength 25 g/100mL
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 Sunsei SPF 45 Sunscreen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 25 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup
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 85791-4531-1 Sunsei SPF 45 Sunscreen 89 mL in 1 TUBE LIQUID 89 2
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 85791-4531-1 85791453101 89 mL in 1 TUBE (85791-4531-1) 89 ml 2026-03-15 No No Current