Home NDC 53863-003 Silk Line Silk Day Cream SPF 15
Product NDC 53863-003
11-digit product format 538630003
Labeler code 53863
Product ID 53863-003_1c24d391-a0a8-85a4-e063-6294a90a51b0
Type HUMAN OTC DRUG
Nonproprietary name Octinoxate, Octocrylene, Octisalate
Dosage form CREAM
Route TOPICAL
Labeler Exelencia Importers, Corp.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-10-26
Substance OCTOCRYLENE; OCTISALATE; OCTINOXATE
Active strength 7; 2; 7.5 g/100mL; 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 Silk Line Silk Day Cream SPF 15
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTOCRYLENE 7 g/100mL OCTISALATE 2 g/100mL OCTINOXATE 7.5 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5A68WGF6WM Internal UNII lookup 4X49Y0596W Internal UNII lookup 4Y5P7MUD51 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53863-003-01 Silk Line Silk Day Cream SPF 15 50 mL in 1 BOX CREAM 50 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53863-003 SILK LINE SILK DAY CREAM SPF 15 (OCTINOXATE, OCTOCRYLENE, OCTISALATE) CREAM [EXELENCIA IMPORTERS, CORP.] 3 Current NDC, Legacy NDC, 1 package rows 20240708_b2d35086-748b-55d0-e053-2995a90a1898.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 Marketing end Sample Exclude flag Status 53863-003-01 53863000301 50 mL in 1 BOX (53863-003-01) 50 ml 2020-10-26 0000-00-00 No No Current