SEPHORA ROUGE BALM SUNSCREEN SPF20 B07-Bashful Beige

SEPHORA ROUGE BALM SUNSCREEN SPF20 B07-Bashful Beige by

Drug Labeling and Warnings

SEPHORA ROUGE BALM SUNSCREEN SPF20 B07-Bashful Beige by is a Otc medication manufactured, distributed, or labeled by INTERCOS EUROPE SPA, Intercos Europe S.p.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SEPHORA ROUGE BALM SUNSCREEN SPF20 B07-BASHFUL BEIGE- octinoxate, octisalate, titanium dioxide lipstick 
INTERCOS EUROPE SPA

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SEPHORA ROUGE BALM SUNSCREEN SPF20 B07-Bashful Beige

Package Labeling:

Outer package5Inner package

SEPHORA ROUGE BALM SUNSCREEN SPF20 B07-BASHFUL BEIGE 
octinoxate, octisalate, titanium dioxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63272-506
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.125 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.83 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ALCOHOL (UNII: 3K9958V90M)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
WATER (UNII: 059QF0KO0R)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CITRUS JUNOS FRUIT RIND (UNII: R13K440UHY)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)  
MICA (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63272-506-161 in 1 CARTON12/19/201512/29/2019
13.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/19/201512/29/2019
Labeler - INTERCOS EUROPE SPA (338578473)
Establishment
NameAddressID/FEIBusiness Operations
INTERCOS EUROPE SPA339447428manufacture(63272-506)
Establishment
NameAddressID/FEIBusiness Operations
Intercos Europe S.p.A.438961310pack(63272-506)

Revised: 12/2019
 
INTERCOS EUROPE SPA