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 00:03:30

Label at a glance#

ProductbareMinerals Original Foundation Broad Spectrum SPF 15 Neutral Dark 24
Active ingredientZINC OXIDE
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 from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20%

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 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-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

mica, may contain: titanium dioxide, iron oxides, bismuth oxychloride

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-888-795-4747

PRINCIPAL DISPLAY PANEL - 8 g Jar Label - Neutral Dark 24

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bareMinerals ®

ORIGINAL FOUNDATION
Broad Spectrum SPF 15

NEUTRAL DARK 24

net wt. 8 g / 0.28 oz.

84240

PRINCIPAL DISPLAY PANEL - 8 g Jar Label - Neutral Dark 24
PRINCIPAL DISPLAY PANEL - 8 g Jar Label - Neutral Dark 24

PRINCIPAL DISPLAY PANEL - 8 g Jar Label - Neutral Deep 29

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bareMinerals ®

ORIGINAL FOUNDATION
Broad Spectrum SPF 15

NEUTRAL DEEP 29

net wt. 8 g / 0.28 oz.

84241

PRINCIPAL DISPLAY PANEL - 8 g Jar Label - Neutral Deep 29
PRINCIPAL DISPLAY PANEL - 8 g Jar Label - Neutral Deep 29

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
98132-026-02bareMinerals Original Foundation Broad Spectrum SPF 15Neutral Dark 242 g in 1 JARPOWDER24
98132-026-08bareMinerals Original Foundation Broad Spectrum SPF 15Neutral Dark 248 g in 1 JARPOWDER84
98132-026-75bareMinerals Original Foundation Broad Spectrum SPF 15Neutral Dark 240.75 g in 1 JARPOWDER0.754
98132-027-02bareMinerals Original Foundation Broad Spectrum SPF 15Neutral Deep 292 g in 1 JARPOWDER24
98132-027-08bareMinerals Original Foundation Broad Spectrum SPF 15Neutral Deep 298 g in 1 JARPOWDER84
98132-027-75bareMinerals Original Foundation Broad Spectrum SPF 15Neutral Deep 290.75 g in 1 JARPOWDER0.754

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
98132-026BAREMINERALS ORIGINAL FOUNDATION BROAD SPECTRUM SPF 15 NEUTRAL DARK 24 (ZINC OXIDE) POWDER BAREMINERALS ORIGINAL FOUNDATION BROAD SPECTRUM SPF 15 NEUTRAL DEEP 29 (ZINC OXIDE) POWDER [ORVEON GLOBAL US LLC]4Current NDC, Legacy NDC, 3 package rows20231207_beaf1ff7-4942-4ba5-ba25-3287cc409e93.zip
98132-027BAREMINERALS ORIGINAL FOUNDATION BROAD SPECTRUM SPF 15 NEUTRAL DARK 24 (ZINC OXIDE) POWDER BAREMINERALS ORIGINAL FOUNDATION BROAD SPECTRUM SPF 15 NEUTRAL DEEP 29 (ZINC OXIDE) POWDER [ORVEON GLOBAL US LLC]4Current NDC, Legacy NDC, 3 package rows20231207_beaf1ff7-4942-4ba5-ba25-3287cc409e93.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
98132-02698132-026-08, 98132-026-02, 98132-026-75
98132-02798132-027-08, 98132-027-02, 98132-027-75

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICAV8A1AW0880IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERRIC OXIDE RED1K09F3G675IACT
BISMUTH OXYCHLORIDE4ZR792I587IACT
ZINC OXIDESOI2LOH54ZACTIB
MICAV8A1AW0880IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERRIC OXIDE RED1K09F3G675IACT
BISMUTH OXYCHLORIDE4ZR792I587IACT
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 Neutral Dark 24ZINC OXIDEOrveon Global US LLCbeaf1ff7-4942-4ba5-ba25-3287cc409e932023-10-04WarningsExact identifier
ndc (package): 98132-027-02
ndc (package): 98132-027-08
ndc (package): 98132-026-08
ndc (package): 98132-026-75
ndc (package): 98132-027-75
ndc (package): 98132-026-02
ndc (product): 98132-026
ndc (product): 98132-027
ndc11 (package): 98132002775
ndc11 (package): 98132002702
ndc11 (package): 98132002602
ndc11 (package): 98132002675
ndc11 (package): 98132002708
ndc11 (package): 98132002608
spl id: 06e78bae-6d9f-667f-e063-6394a90a8322
spl set id: beaf1ff7-4942-4ba5-ba25-3287cc409e93

Reported adverse events (FAERS/openFDA)#

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