Exel Clarifying Line

Product NDC
67623-001
11-digit product format
676230001
Labeler code
67623
Product ID
67623-001_1b9444d4-edaa-7291-e063-6394a90a25d3
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Octocrylene, Oxybenzone, Tatanium Dioxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Biocosmetica Exel Argentina SRL
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-05-14
Substance
OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE
Active strength
7.5; 8; 3; 5 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
Brand name suffix
SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE7.5 g/100mL
OCTOCRYLENE8 g/100mL
OXYBENZONE3 g/100mL
TITANIUM DIOXIDE5 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4Y5P7MUD51, 5A68WGF6WM, 95OOS7VE0Y, 15FIX9V2JP

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67623-001-022023-04-12C16284748780-1f386c649-e028-0266-e053-dadaa90a7c1aExel Clarifying Line SPF 50
67623-001-022023-01-30C16284748780-1f386c649-e028-0266-e053-dadaa90a7c1aExel Clarifying Line SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67623-001-01Exel Clarifying LineSPF 50100 mL in 1 TUBECREAM1004
67623-001-02Exel Clarifying LineSPF 501 in 1 PACKAGECREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67623-001EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [BIOCOSMETICA EXEL ARGENTINA SRL]4Current NDC, Legacy NDC, 2 package rows20240708_e65a68f6-d1b7-4cbf-a3f8-5cc04036221a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67623-001-0167623000101100 mL in 1 TUBE100 mlHistorical
67623-001-02676230001021 TUBE in 1 PACKAGE (67623-001-02) / 100 mL in 1 TUBE (67623-001-01) 1 tube2015-05-140000-00-00NoNoCurrent