Home NDC 60232-0035 Private Label SPF 50 80 min Water Resistant
Product NDC 60232-0035
11-digit product format 602320035
Labeler code 60232
Product ID 60232-0035_6a3535ae-574f-48d8-bfc0-5b38f54c93ee
Type HUMAN OTC DRUG
Nonproprietary name homosalate, octisalate, zinc oxide sunscreen
Dosage form CREAM
Route TOPICAL
Labeler Swiss-American CDMO, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-12-01
Substance HOMOSALATE; OCTISALATE; ZINC OXIDE
Active strength 100; 50; 165 g/1000g; 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 Private Label SPF 50 80 min Water Resistant
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HOMOSALATE 100 g/1000g OCTISALATE 50 g/1000g ZINC OXIDE 165 g/1000g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V06SV4M95S Internal UNII lookup 4X49Y0596W 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 60232-0035-1 Private Label SPF 50 80 min Water Resistant 1000 g in 1 TUBE CREAM 1000 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60232-0035 PRIVATE LABEL SPF 50 80 MIN WATER RESISTANT (HOMOSALATE, OCTISALATE, ZINC OXIDE SUNSCREEN) CREAM [SWISS-AMERICAN CDMO, LLC] 4 Current NDC, 1 package rows 20231115_8849fa88-24c8-410d-b16e-60da38288f98.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 60232-0035-1 60232003501 1000 g in 1 TUBE (60232-0035-1) 1000 g 2020-12-01 No No Current