FDA.reportPublic FDA data

SEPHORA ROUGE BALM SUNSCREEN SPF20 B07-Bashful Beige

Manufacturer
S+
Effective date
2018-02-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 01:03:19

Label at a glance#

ProductSEPHORA ROUGE BALM SUNSCREEN SPF20 B07-Bashful Beige
Active ingredientOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE
Label structure7 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.125%

Octisalate 3%

Titanium Dioxide 1.83%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

  • Helps protect against sunburn.

Warnings

WARNINGS SECTION

​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

OTC - DO NOT USE SECTION

  • on damaged or broken skin

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash occurs

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

DIISOSTEARYL MALATE, OCTYLDODECANOL, ISOSTEARYL ISOSTEARATE, POLYBUTENE, POLYETHYLENE, MICROCRYSTALLINE WAX, SYNTHETIC BEESWAX, POLYGLYCERYL-3 DIISOSTEARATE, DIPENTAERYTHRITYL HEXAHYDROOXYSTEARATE, DICALCIUM PHOSPHATE, 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,RED 6, RED 28 LAKE, IRON OXIDES, BLUE 1 LAKE

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer package5Outer package5Inner packageInner package

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
31720-50631720-506-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIISOSTEARYL MALATEQBS8A3XZGQIACT
OCTYLDODECANOL461N1O614YIACT
ISOSTEARYL ISOSTEARATEIV0Z586Z4YIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE74J1X57U42IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
MICAV8A1AW0880IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
ALCOHOL3K9958V90MIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)255PIF62MSIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
WATER059QF0KO0RIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CITRUS JUNOS FRUIT RINDR13K440UHYIACT
ETHYLHEXYL PALMITATE2865993309IACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
HYALURONATE SODIUMYSE9PPT4THIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
D&C RED NO. 6481744AI4OIACT
FERRIC OXIDE RED1K09F3G675IACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c7d04b6c-5822-93c5-e053-2995a90af75e91b9c119-7b7c-4877-99ec-e44f62f0c7672021-07-23WarningsExact identifier
spl set id: 91b9c119-7b7c-4877-99ec-e44f62f0c767

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.