Home NDC 68577-112 Leg Body Makeup
Product NDC 68577-112
11-digit product format 685770112
Labeler code 68577
Product ID 68577-112_2a251aa3-98f0-2790-e063-6394a90a8a0e
Type HUMAN OTC DRUG
Nonproprietary name Octisalate, Octocrylene
Dosage form CREAM
Route TOPICAL
Labeler COSMAX USA, CORPORATION
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-06-01
Substance OCTOCRYLENE; OCTISALATE
Active strength 6; 3.2 mg/100mg; mg/100mg
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 Leg Body Makeup
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTOCRYLENE 6 mg/100mg OCTISALATE 3.2 mg/100mg
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5A68WGF6WM 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 68577-112-01 Leg Body Makeup 1 in 1 CARTON CREAM 1 2 68577-112-01 Leg Body Makeup 100 mg in 1 TUBE CREAM 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68577-112 LEG BODY MAKEUP (OCTISALATE, OCTOCRYLENE) CREAM [COSMAX USA, CORPORATION] 2 Current NDC, 2 package rows 20241228_0cc9760b-b88b-f291-e063-6294a90a242f.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 302 of 346 · 6,912 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68577-112-01 68577011201 1 TUBE in 1 CARTON (68577-112-01) / 100 mg in 1 TUBE 1 tube 2023-06-01 No No Current