FDA.reportPublic FDA data

Titanium Dioxide

Manufacturer
Bare Escentuals Beauty, Inc.
Effective date
2019-02-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:58:26

Label at a glance#

ProductbareMinerals BarePRO Made-2-Fit Performance Wear Foundation Broad Spectrum SPF 15
Active ingredientTitanium Dioxide
Label structure11 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

For sunscreen use: apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours children under 6 months: ask a doctor Sun Protection Measures . Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection me...

Storage and handling

Protect this product in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 3.32%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months: ask a doctor
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. – 2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water, cyclopentasiloxane, trimethylsiloxysilicate, butylene glycol, silica, peg-10 dimethicone, bis-butyldimethicone polyglyceryl-3, bambusa arundinacea stem extract, sodium glutamate, disteardimonium hectorite, sorbitan sesquiisostearate, hydrogenated lecithin, methicone, papain, aluminum hydroxide, stearic acid, 1,2-hexanediol, caprylyl glycol, carbomer, algin, tocopherol, sodium dehydroacetate, phenoxyethanol. may contain (+/-): titanium dioxide, iron oxides.

Other information

STORAGE AND HANDLING SECTION

Protect this product in this container from excessive heat and direct sun.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-795-4747

SPL UNCLASSIFIED SECTION

Dist. by bareMinerals, New York, NY 10022, USA

PRINCIPAL DISPLAY PANEL - 30 mL Tip Card

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bareMinerals®

BAREPRO®

PERFORMANCE WEAR LIQUID FOUNDATION SPF 15
24 HOUR WEAR • FULL COVERAGE • SKIN IMPROVING

MEET YOUR
PERFECT MATCH

CUSTOMIZED BY
MATCH Co

WE WOULD LOVE TO SEE YOUR PERFECT MATCH
SHARE AND TAG — #MADE2FIT

PRINCIPAL DISPLAY PANEL - 30 mL Tip Card
PRINCIPAL DISPLAY PANEL - 30 mL Tip Card

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
98132-253-302021-01-29C16284748780-1ba0f9c33-54c5-a910-e053-dadaa90a0b85bareMinerals ® BarePRO ® Made-2-Fit Performance Wear Liquid Foundation Broad Spectrum SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
98132-253-30bareMinerals BarePRO Made-2-Fit Performance Wear Foundation Broad Spectrum SPF 151 in 1 BOXLIQUID11
98132-253-30bareMinerals BarePRO Made-2-Fit Performance Wear Foundation Broad Spectrum SPF 1530 mL in 1 BOTTLE, GLASSLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
98132-253BAREMINERALS BAREPRO MADE-2-FIT PERFORMANCE WEAR FOUNDATION BROAD SPECTRUM SPF 15 (TITANIUM DIOXIDE) LIQUID [BARE ESCENTUALS BEAUTY, INC.]1Legacy NDC, 2 package rows20190203_5d6e862a-0ae1-451e-a119-ae9e4f696978.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
98132-25398132-253-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
Water059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
Butylene Glycol3XUS85K0RAIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
BAMBUSA BAMBOS STEMNRA4497HC5IACT
MONOSODIUM GLUTAMATEW81N5U6R6UIACT
Disteardimonium HectoriteX687XDK09LIACT
Sorbitan SesquiisostearateVU97D01BF9IACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
METHICONE (20 CST)6777U11MKTIACT
PapainA236A06Y32IACT
Aluminum Hydroxide5QB0T2IUN0IACT
Stearic Acid4ELV7Z65APIACT
1,2-HexanediolTR046Y3K1GIACT
Caprylyl Glycol00YIU5438UIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
SODIUM ALGINATEC269C4G2ZQIACT
TocopherolR0ZB2556P8IACT
Sodium Dehydroacetate8W46YN971GIACT
PhenoxyethanolHIE492ZZ3TIACT
FERRIC OXIDE RED1K09F3G675IACT

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
7c3ed749-63a4-4d7b-8ce6-5362657a09695d6e862a-0ae1-451e-a119-ae9e4f6969782019-02-01WarningsExact identifier
spl id: 7c3ed749-63a4-4d7b-8ce6-5362657a0969
spl set id: 5d6e862a-0ae1-451e-a119-ae9e4f696978

Reported adverse events (FAERS/openFDA)#

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