NDC 53863-120

Sunscreen Creme SPF 37 Exel

Octocrylene,octinoxate,octisalate,oxybenzone,titanium Dioxide

Sunscreen Creme SPF 37 Exel is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Exelencia Importers Corp. The primary component is Octocrylene; Octinoxate; Octisalate; Oxybenzone; Titanium Dioxide.

Product ID53863-120_dd2e2774-4545-43e7-a423-4c53b97fdfbd
NDC53863-120
Product TypeHuman Otc Drug
Proprietary NameSunscreen Creme SPF 37 Exel
Generic NameOctocrylene,octinoxate,octisalate,oxybenzone,titanium Dioxide
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2012-10-15
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart352
Labeler NameExelencia Importers Corp
Substance NameOCTOCRYLENE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE
Active Ingredient Strength5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 53863-120-02

1 BOTTLE in 1 CARTON (53863-120-02) > 50 mL in 1 BOTTLE (53863-120-01)
Marketing Start Date2012-10-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53863-120-01 [53863012001]

Exel Exel CREAM
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-10-15

NDC 53863-120-02 [53863012002]

Exel Exel CREAM
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-10-15
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
OCTOCRYLENE5 g/100mL

OpenFDA Data

SPL SET ID:bfcf87c0-27c4-4fba-9f4e-77e7132e073a
Manufacturer
UNII

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