Home NDC 84271-001 SEYTU Body Sunscreen
Product NDC 84271-001
11-digit product format 842710001
Labeler code 84271
Product ID 84271-001_1959d76a-87e7-4cdd-9f18-40635e23e2a7
Type HUMAN OTC DRUG
Nonproprietary name titanium dioxide and zinc oxide
Dosage form CREAM
Route TOPICAL
Labeler Omnilife USA, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-04-15
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 8.3; 4.875 g/100mL; 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 SEYTU Body Sunscreen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 8.3 g/100mL ZINC OXIDE 4.875 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 15FIX9V2JP Internal UNII lookup SOI2LOH54Z Internal UNII lookup
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 84271-001-01 SEYTU Body Sunscreen 1 in 1 BOX CREAM 1 2 84271-001-01 SEYTU Body Sunscreen 120 mL in 1 TUBE CREAM 120 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 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 84271-001-01 84271000101 1 TUBE in 1 BOX (84271-001-01) / 120 mL in 1 TUBE 1 tube 2024-04-15 No No Current