Home NDC 60232-0044 Physical Sunscreen SPF50 80 min WR 159-100
Product NDC 60232-0044
11-digit product format 602320044
Labeler code 60232
Product ID 60232-0044_6943f1b5-dc1d-49af-a51e-4c4bb778c45b
Type HUMAN OTC DRUG
Nonproprietary name titanium dioxide, titanium dioxide sunscreen
Dosage form LOTION
Route TOPICAL
Labeler Swiss-American CDMO, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-11-09
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 42.3; 182.8 g/1000g; g/1000g
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 Physical Sunscreen SPF50 80 min WR 159-100
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 42.3 g/1000g ZINC OXIDE 182.8 g/1000g
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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60232-0044-1 Physical Sunscreen SPF50 80 min WR 159-100 90 g in 1 PACKAGE LOTION 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60232-0044 PHYSICAL SUNSCREEN SPF50 80 MIN WR 159-100 (TITANIUM DIOXIDE, TITANIUM DIOXIDE SUNSCREEN) LOTION [SWISS-AMERICAN CDMO, LLC] 2 Current NDC, 1 package rows 20231110_0cca7b65-e24a-429c-b157-5f4e343424ab.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 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 60232-0044-1 60232004401 90 g in 1 PACKAGE (60232-0044-1) 90 g 2023-11-09 No No Current