NDC 53863-124

Clarifying Line Broad Spectrum SPF 50 EXEL

Octinoxate, Octocrylene, Oxybenzone, Titanium Dioxide

Clarifying Line Broad Spectrum SPF 50 EXEL is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Exelencia Importers. The primary component is Octinoxate; Octocrylene; Oxybenzone; Titanium Dioxide.

Product ID53863-124_06e8b1e4-f6f1-4a7e-bad7-102dfcb2ca29
NDC53863-124
Product TypeHuman Otc Drug
Proprietary NameClarifying Line Broad Spectrum SPF 50 EXEL
Generic NameOctinoxate, Octocrylene, Oxybenzone, Titanium Dioxide
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2015-02-23
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart352
Labeler NameExelencia importers
Substance NameOCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE
Active Ingredient Strength8 g/100mL; g/100mL; g/100mL; g/100mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 53863-124-02

1 TUBE in 1 CARTON (53863-124-02) > 100 mL in 1 TUBE (53863-124-01)
Marketing Start Date2015-02-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53863-124-01 [53863012401]

Clarifying Line Broad Spectrum SPF 50 EXEL CREAM
Marketing CategoryOTC monograph final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-02-23

NDC 53863-124-02 [53863012402]

Clarifying Line Broad Spectrum SPF 50 EXEL CREAM
Marketing CategoryOTC monograph final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-02-23
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
OCTINOXATE7.5 g/100mL

OpenFDA Data

SPL SET ID:a13145c5-e7e1-434a-8b39-52c8b8ba8863
Manufacturer
UNII
UPC Code
  • 7798114894099

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