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

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 S+. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Octinoxate 7.125%

Octisalate 3%

Titanium Dioxide 1.83%

Purpose

Sunscreen

Use

• Helps protect against sunburn.

Warnings

​Skin Cancer/Skin Agent 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 axcessive heat and direct sun

Inactive ingredients

DIISOSTEARYL MALATE, OCTYLDODECANOL, ISOSTEARYL ISOSTEARATE, POLYBUTENE, POLYETHYLENE, MICROCRYSTALLINE WAX, SYNTHETIC BEESWAX, POLYGLYCERYL-3 DIISOSTEARATE, DICALCIUM PHOSPHATE, DIPENTAERYTHRITYL HEXAHYDROOXYSTEARATE, MICA, DISTEARDIMONIUM HECTORITE, ALCOHOL,SILICA, FRAGRANCE (PARFUM), PENTAERTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, ALUMINUM HYDROXIDE, WATER (AQUA), TOCOPHERYL ACETATE, CITRUS JUNOS PEEL EXTRACT, ETHYLHEXYL PALMITATE, SILICA DIMETHYL SILYLATE, BUTYLENE GLYCOL, CARPRYLYL GLYCOL, PHENOXYETHANOL, SODIUM HYALURONATE, HEXYLENE GLYCOL, RED 7 LAKE, BLUE 1 LAKE

Package Labeling:

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 31720-508
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: 31720-508-16	1 in 1 CARTON	12/18/2015
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

Labeler - S+ (572406531)