NDC 68327-005

BritePrep FX

Octocrylene, Octinoxate, Oxybenzone,titanium Dioxide

BritePrep FX is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Cover Fx Skin Care, Inc.. The primary component is Octocrylene; Octinoxate; Oxybenzone; Titanium Dioxide.

Product ID68327-005_048bb7e5-b132-4b36-8274-8c8db1c1fb07
NDC68327-005
Product TypeHuman Otc Drug
Proprietary NameBritePrep FX
Generic NameOctocrylene, Octinoxate, Oxybenzone,titanium Dioxide
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2010-07-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart352
Labeler NameCover FX Skin Care, Inc.
Substance NameOCTOCRYLENE; OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE
Active Ingredient Strength9 g/100mL; g/100mL; g/100mL; g/100mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68327-005-02

15 mL in 1 TUBE (68327-005-02)
Marketing Start Date2010-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68327-005-02 [68327000502]

BritePrep FX CREAM
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-07-01
Inactivation Date2020-01-31

NDC 68327-005-03 [68327000503]

BritePrep FX CREAM
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-07-01
Inactivation Date2020-01-31

NDC 68327-005-01 [68327000501]

BritePrep FX CREAM
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-07-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
OCTOCRYLENE9 g/100mL

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.