FDA.reportPublic FDA data

bareMinerals Original Foundation Broad Spectrum SPF 15

Manufacturer
Orveon Global US LLC
Effective date
2023-10-04
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:03:22

Label at a glance#

ProductbareMinerals Original Foundation Broad Spectrum SPF 15 Medium Beige 12
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure9 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 children under 6 months: ask a doctor 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 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 mea...

Storage and handling

Protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient(s)Purpose
Titanium dioxide 12.6%Sunscreen
Zinc oxide 21.8%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 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
  • children under 6 months: ask a doctor
  • 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 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-sleeved shirts, pants, hats, and sunglasses.

Other information

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

bismuth oxychloride, mica, iron oxides.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-888-795-4747

PRINCIPAL DISPLAY PANEL - 8 g Jar Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bareMinerals ®

ORIGINAL FOUNDATION
Broad Spectrum SPF 15

MEDIUM BEIGE 12

net wt. 8 g / 0.28 oz.

61272

PRINCIPAL DISPLAY PANEL - 8 g Jar Label
PRINCIPAL DISPLAY PANEL - 8 g Jar Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
98132-024-08bareMinerals Original Foundation Broad Spectrum SPF 15Medium Beige 128 g in 1 JARPOWDER84

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
98132-024BAREMINERALS ORIGINAL FOUNDATION BROAD SPECTRUM SPF 15 MEDIUM BEIGE 12 (TITANIUM DIOXIDE AND ZINC OXIDE) POWDER [ORVEON GLOBAL US LLC]4Current NDC, Legacy NDC, 1 package rows20231207_3c35fd13-1a4b-4acf-ada4-16ee2e52dd94.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
98132-02498132-024-08

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
MICAV8A1AW0880IACT
FERRIC OXIDE RED1K09F3G675IACT
BISMUTH OXYCHLORIDE4ZR792I587IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB

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
bareMinerals Original Foundation Broad Spectrum SPF 15 Medium Beige 12TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLC3c35fd13-1a4b-4acf-ada4-16ee2e52dd942023-10-04WarningsExact identifier
ndc (package): 98132-024-08
ndc (product): 98132-024
ndc11 (package): 98132002408
spl id: 06e768c5-8c28-3e1d-e063-6394a90a5cc5
spl set id: 3c35fd13-1a4b-4acf-ada4-16ee2e52dd94

Reported adverse events (FAERS/openFDA)#

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