SEPHORA ROUGE BALM SUNSCREEN SPF20 B06-SOFT RED- octinoxate, octisalate, titanium dioxide lipstick 
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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 B06-Soft Red

Drug Facts

Active ingredients

Octinoxate 7.125%

Octisalate 3%

Titanium dioxide 1.83%

Purpose

Sunscreen

Use

  • Helps protect against sunburn.

Warnings

Sking Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

Do not use

  • on damaged or broken skin

Stop use and ask a doctor if

  • rash occurs

Directions

  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating

Other information

  • Protect the product in this container from excessive heat and direct sun

Inactive ingredients

DIISOSTEARYL MALATE, OCTYLDODECANOL, ISOSTEARYL ISOSTEARATE, POLYBUTENE, POLYETHYLENE, MICROCRYSTALLINE WAX,
SYNTHETIC BEESWAX, POLYGLYCERYL-3 DIISOSTEARATE, DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE, DICALCIUM PHOSPHATE, MICA,
DISTEARDIMONIUM HECTORITE, ALCOHOL, SILICA, FRAGRANCE (PARFUM), PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE,
ALUMINUM HYDROXIDE, WATER (AQUA), TOCOPHEROL ACETATE, CITRUS JUNOS PEEL EXTRACT, ETHYLHEXYL PALMITATE, SILICA DIMETHYL SILYLATE, BUTYLENE GLYCOL, CAPRYLYL GLYCOL, PHENOXYETHANOL, SODIUM HYALURONATE, HEXYLENE GLYCOL, RED 7 LAKE,RED 6, YELLOW 6 LAKE

Outer package4Inner package

SEPHORA ROUGE BALM SUNSCREEN SPF20 B06-SOFT RED 
octinoxate, octisalate, titanium dioxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:31720-505
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
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)  
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
MICA (UNII: V8A1AW0880)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ALCOHOL (UNII: 3K9958V90M)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:31720-505-161 in 1 CARTON12/19/201511/28/2019
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 finalpart35212/19/201511/28/2019
Labeler - S+ (572406531)

Revised: 7/2021
Document Id: c7d04b6c-5821-93c5-e053-2995a90af75e
Set id: 746c15c0-7ef9-498d-bd2c-f5c43aecc8d0
Version: 5
Effective Time: 20210723
 
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