Home NDC 76162-957 Homosalate, Octisalate, Zinc oxide
Product NDC 76162-957
11-digit product format 761620957
Labeler code 76162
Product ID 76162-957_4ab9f7f0-adbb-d8a3-e063-6394a90ad8d0
Type HUMAN OTC DRUG
Nonproprietary name Homosalate, Octisalate, Zinc oxide
Dosage form LOTION
Route TOPICAL
Labeler Topco Associates LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-01-22
Substance HOMOSALATE; ZINC OXIDE; OCTISALATE
Active strength 100; 63; 50 mg/mL; mg/mL; mg/mL
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 Homosalate, Octisalate, Zinc oxide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HOMOSALATE 100 mg/mL ZINC OXIDE 63 mg/mL OCTISALATE 50 mg/mL
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 SOI2LOH54Z Internal UNII lookup 4X49Y0596W 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 76162-957-21 Homosalate, Octisalate, Zinc oxide 89 mL in 1 BOTTLE, PLASTIC LOTION 89 2 76162-957-21 Homosalate, Octisalate, Zinc oxide 1 in 1 CARTON LOTION 1 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 Marketing start Sample Exclude flag Status 76162-957-21 76162095721 1 BOTTLE, PLASTIC in 1 CARTON (76162-957-21) / 89 mL in 1 BOTTLE, PLASTIC 2026-01-22 No No Current