SEPHORA ROUGE BALM SUNSCREEN SPF20 B09-Mild Plum

SEPHORA ROUGE BALM SUNSCREEN SPF20 B09-Mild Plum by

Drug Labeling and Warnings

SEPHORA ROUGE BALM SUNSCREEN SPF20 B09-Mild Plum 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 B09-MILD PLUM- 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 B09-Mild Plum

Package Labeling

SEPHORA ROUGE BALM SUNSCREEN SPF20 B09-MILD PLUM 
octinoxate, octisalate, titanium dioxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63272-508
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.125 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.83 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63272-508-16	1 in 1 CARTON	12/18/2015	12/20/2019
1		3.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/18/2015	12/20/2019

Labeler - INTERCOS EUROPE SPA (338578473)

Establishment
Name	Address	ID/FEI	Business Operations
INTERCOS EUROPE SPA		339447428	manufacture(63272-508)

Establishment
Name	Address	ID/FEI	Business Operations
Intercos Europe S.p.A.		438961310	pack(63272-508)

Revised: 12/2019

Document Id: 9983d603-b7ca-5979-e053-2995a90adf8b

34390-5

Set id: 029c3295-90ff-4af0-a456-33f736a1e630

Version: 4

Effective Time: 20191212