Home NDC 53863-005 EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUS
Product NDC 53863-005
11-digit product format 538630005
Labeler code 53863
Product ID 53863-005_2a845e4c-86e8-1799-e063-6294a90a9b2b
Type HUMAN OTC DRUG
Nonproprietary name octocrylene, octinoxate, octisalate, titanium dioxide, ensulizole
Dosage form CREAM
Route TOPICAL
Labeler Exelencia importers Corp.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-01-01
Substance ENSULIZOLE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE
Active strength 4; 5; 5; 10; 5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUS
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ENSULIZOLE 4 g/100mL OCTINOXATE 5 g/100mL OCTISALATE 5 g/100mL OCTOCRYLENE 10 g/100mL TITANIUM DIOXIDE 5 g/100mL
Harmonized Identifiers# Field, Values table Field Values Unii 9YQ9DI1W42, 4Y5P7MUD51, 4X49Y0596W, 5A68WGF6WM, 15FIX9V2JP
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53863-005-01 EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUS 100 mL in 1 TUBE CREAM 100 1 53863-005-01 EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUS 1 in 1 CARTON CREAM 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53863-005 EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUS (OCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLE) CREAM [EXELENCIA IMPORTERS CORP.] 1 Current NDC, 2 package rows 20250113_2a845e4c-86e7-1799-e063-6294a90a9b2b.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 53863-005-01 53863000501 1 TUBE in 1 CARTON (53863-005-01) / 100 mL in 1 TUBE 1 tube 2025-01-01 No No Current