Home NDC 83294-101 SPF 30 Sunscreen
Product NDC 83294-101
11-digit product format 832940101
Labeler code 83294
Product ID 83294-101_471ab663-50b0-9e95-e063-6294a90a6115
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide, Titanium Dioxide
Dosage form LOTION
Route TOPICAL
Labeler CLEURE
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-08-22
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength 9; 4.51 g/100mL; g/100mL
NDC exclude flag No
Listing certified through 2026-12-31
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 SPF 30 Sunscreen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 9 g/100mL TITANIUM DIOXIDE 4.51 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup 15FIX9V2JP 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 83294-101-18 SPF 30 Sunscreen 118 mL in 1 TUBE LOTION 118 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83294-101 SPF 30 SUNSCREEN (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [CLEURE] 3 Current NDC, 1 package rows 20250101_f5512f34-08ee-b0f6-e053-2a95a90ab5bd.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 27 of 361 · 7,213 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83294-101-18 83294010118 118 mL in 1 TUBE (83294-101-18) 118 ml 2022-08-22 No No Current