NDC 65371-025

BB ANTI-FATIGUE ABSOLUTE SPF 25

Homosalate, Octisalate, And Oxybenzone

BB ANTI-FATIGUE ABSOLUTE SPF 25 is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Orlane S.a.. The primary component is Homosalate; Octisalate; Oxybenzone.

Product ID65371-025_a248570a-8143-440d-8395-fc2be4548b08
NDC65371-025
Product TypeHuman Otc Drug
Proprietary NameBB ANTI-FATIGUE ABSOLUTE SPF 25
Generic NameHomosalate, Octisalate, And Oxybenzone
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2013-04-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart352
Labeler NameORLANE S.A.
Substance NameHOMOSALATE; OCTISALATE; OXYBENZONE
Active Ingredient Strength90 mg/mL; mg/mL; mg/mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 65371-025-02

1 TUBE in 1 CARTON (65371-025-02) > 30 mL in 1 TUBE
Marketing Start Date2013-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65371-025-02 [65371002502]

BB ANTI-FATIGUE ABSOLUTE SPF 25 CREAM
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-04-01
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
HOMOSALATE90 mg/mL

OpenFDA Data

SPL SET ID:38884b6d-f5ae-4b82-8762-bef00fccee46
Manufacturer
UNII

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