Home NDC 54111-173 Tone Control Morning Cream SPF 15
Product NDC 54111-173
11-digit product format 541110173
Labeler code 54111
Product ID 54111-173_709441eb-04f8-401a-aa05-86aa457261f9
Type HUMAN OTC DRUG
Nonproprietary name Octocrylene and Octisalate Cream
Dosage form CREAM
Route TOPICAL
Labeler Bentley Laboratories, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-07-18
Substance OCTOCRYLENE; OCTISALATE
Active strength 5; 2 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 Tone Control Morning Cream SPF 15
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTOCRYLENE 5 g/100mL OCTISALATE 2 g/100mL
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 54111-173-20 Tone Control Morning Cream SPF 15 20 mL in 1 TUBE CREAM 20 3 54111-173-60 Tone Control Morning Cream SPF 15 60 mL in 1 TUBE CREAM 60 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54111-173 TONE CONTROL MORNING CREAM SPF 15 (OCTOCRYLENE AND OCTISALATE CREAM) CREAM [BENTLEY LABORATORIES, LLC] 3 Current NDC, 2 package rows 20241228_b4e3cd1c-ae42-4995-a314-96d24d328e41.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 54111-173-20 54111017320 20 mL in 1 TUBE (54111-173-20) 20 ml 2023-07-18 No No Current 54111-173-60 54111017360 60 mL in 1 TUBE (54111-173-60) 60 ml 2023-07-18 No No Current