FDA.reportPublic FDA data

Medium Foundation SPF 15

Manufacturer
Bare Escentuals Beauty Inc. | Ei Inc.
Effective date
2013-02-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 01:41:53

Label at a glance#

ProductMedium Foundation SPF 15
Active ingredientTitanium Dioxide
Label structure8 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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 25%

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

  • Skin cancer/skin aging alert: spending time in the sun increases your risk of cancer and early aging
  • This product has been shown only to help prevent sunburn, not skin cancer or early aging
  • For External use only
  • Do not use on damage or broken skin
  • When using this product keep out of eyes. Rinse with water to remove
  • Stop use and ask doctor if rash occurs
  • 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

  • Apply liberally 15 minutes before sun exposure
  • Use a water-resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • Sun protection measures. Spending time in the sun increases your risk of skin cancer or early skin aging. To decrease this risk, regularly use a 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
  • Children under 6 month: ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Bismuth Oxychloride, Iron Oxides, Mica, Titanium Dioxide

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 1-888-795-4747

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label-8glabel-8glabel continuedlabel continuedlabel continuedlabel continuedlabel 18glabel 18g

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
98132-880-082021-08-20C16284748780-19d75b9d0-3bc8-f424-e053-dadaa90a57ceBareMineral Original SPF 15 Foundation Medium
98132-880-182021-08-20C16284748780-19d75b9d0-3bc8-f424-e053-dadaa90a57ceBareMineral Original SPF 15 Foundation Medium
98132-880-082020-01-31C16284748780-19d75b9d0-3bc8-f424-e053-dadaa90a57ceBareMineral Original SPF 15 Foundation Medium
98132-880-182020-01-31C16284748780-19d75b9d0-3bc8-f424-e053-dadaa90a57ceBareMineral Original SPF 15 Foundation Medium

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Titanium DioxideACTIVE INGREDIENT15FIX9V2JP4
Titanium DioxideACTIVE MOIETY15FIX9V2JP4
BISMUTH OXYCHLORIDEINACTIVE INGREDIENT4ZR792I5874
BROWN IRON OXIDEINACTIVE INGREDIENT1N032N7MFO4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT4
MICAINACTIVE INGREDIENTV8A1AW08804

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
98132-88098132-880-08, 98132-880-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
MICAV8A1AW0880IACT
BISMUTH OXYCHLORIDE4ZR792I587IACT
BROWN IRON OXIDE1N032N7MFOIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 23 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTGRANULE, FOR SUSPENSION / ORAL11 mgExact identifier — unii candidate
20 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, FILM COATED / ORAL6 mgExact identifier — unii candidate
20 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, EXTENDED RELEASE / ORAL15 mgExact identifier — unii candidate
20 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTPOWDER / RESPIRATORY (INHALATION)0.04 mgExact identifier — unii candidate
20 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
20 equally ranked IID candidates
BROWN IRON OXIDEBROWN IRON OXIDE1N032N7MFOTABLET / ORAL0.79 mgExact identifier — unii candidate
3 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, DELAYED RELEASE / ORAL3 mgExact identifier — unii candidate
20 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE / ORAL14 mgExact identifier — unii candidate
20 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
20 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET / SUBLINGUAL1 mgExact identifier — unii candidate
20 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET / BUCCAL1 mgExact identifier — unii candidate
20 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii candidate
20 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTPOWDER, FOR SUSPENSION / ORAL3 mgExact identifier — unii candidate
20 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET / ORAL24 mgExact identifier — unii candidate
20 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, COATED / ORAL1 mgExact identifier — unii candidate
20 equally ranked IID candidates
BROWN IRON OXIDEBROWN IRON OXIDE1N032N7MFOTABLET, FILM COATED / ORAL0.2 mgExact identifier — unii candidate
3 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, CHEWABLE / ORAL14 mgExact identifier — unii candidate
20 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTSUSPENSION / ORAL6 mgExact identifier — unii candidate
20 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, DELAYED RELEASE / ORAL7 mgExact identifier — unii candidate
20 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTFILM / BUCCAL0.27 mgExact identifier — unii candidate
20 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
20 equally ranked IID candidates
BROWN IRON OXIDEBROWN IRON OXIDE1N032N7MFOCAPSULE / ORALNAExact identifier — unii candidate
3 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, COATED / ORAL0.01 mgExact identifier — unii candidate
20 equally ranked IID candidates

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
2802da90-f568-474e-94ea-005ec96ae0c6b29403b4-d81e-4f5e-89c8-736a7cfe65732021-08-20WarningsExact identifier
spl set id: b29403b4-d81e-4f5e-89c8-736a7cfe6573

Reported adverse events (FAERS/openFDA)#

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