FDA.reportPublic FDA data

bareMinerals Original Foundation Broad Spectrum SPF 15

Product NDC
98132-021
11-digit product format
981320021
Labeler code
98132
Product ID
98132-021_06e81c98-d6dc-d54a-e063-6394a90a04e0
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE and ZINC OXIDE
Dosage form
POWDER
Route
TOPICAL
Labeler
Orveon Global US LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-08-01
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
560; 1600 mg/8g; mg/8g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
bareMinerals Original Foundation Broad Spectrum SPF 15
Brand name suffix
Warm Dark 26
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE560 mg/8g
ZINC OXIDE1600 mg/8g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
828fe263-f223-45c3-9710-fd8d59ad56b1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
98132-021-02bareMinerals Original Foundation Broad Spectrum SPF 15Warm Dark 262 g in 1 JARPOWDER24
98132-021-08bareMinerals Original Foundation Broad Spectrum SPF 15Warm Dark 268 g in 1 JARPOWDER84
98132-021-75bareMinerals Original Foundation Broad Spectrum SPF 15Warm Dark 260.75 g in 1 JARPOWDER0.754

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
98132-021BAREMINERALS ORIGINAL FOUNDATION BROAD SPECTRUM SPF 15 MEDIUM DARK 23 (TITANIUM DIOXIDE AND ZINC OXIDE) POWDER BAREMINERALS ORIGINAL FOUNDATION BROAD SPECTRUM SPF 15 WARM TAN 22 (TITANIUM DIOXIDE AND ZINC OXIDE) POWDER BAREMINERALS ORIGINAL FOUNDATION BROAD SPECTRUM SPF 15 GOLDEN DARK 25 (TITANIUM DIOXIDE AND ZINC OXIDE) POWDER BAREMINERALS ORIGINAL FOUNDATION BROAD SPECTRUM SPF 15 WARM DARK 26 (TITANIUM DIOXIDE AND ZINC OXIDE) POWDER BAREMINERALS ORIGINAL FOUNDATION BROAD SPECTRUM SPF 15 WARM DEEP 27 (TITANIUM DIOXIDE AND ZINC OXIDE) POWDER [ORVEON GLOBAL US LLC]4Current NDC, Legacy NDC, 3 package rows20231207_828fe263-f223-45c3-9710-fd8d59ad56b1.zip

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 244 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Refreshing Water Hydration Stick SPF 50AVOBENZONE OCTISALATE HOMOSALATE OCTOCRYLENECOOLA LLC6da037f8-bedb-467a-b534-e44752120f2c2024-12-27WarningsExact identifier
application number: M020
Nu Skin ageLOC Radiant Day Broad Spectrum SPF 22AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENENSE Products, Inc.649a9c28-bfd4-404c-90d5-5d0ea8c7b6452024-12-27WarningsExact identifier
application number: M020
Kiehls Since 1851 Activated Sun Protector For Face and Body Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDEL'Oreal USA Products Inc87496037-36ca-4c5f-973f-46626cf4096e2024-12-27WarningsExact identifier
application number: M020
PORESCREEN SPF40ZINC OXIDEDermalogica, LLC.37a7362a-b251-4d3a-a957-65d8f338fa122024-12-27WarningsExact identifier
application number: M020
COOLA Classic Face Sunscreen Fragrance-Free SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLC12ff4689-f7e2-49db-8848-608c61b41ef02024-12-27WarningsExact identifier
application number: M020
NUDESCREEN LIP PRIMER SPF 30 - NATURAL TINTZINC OXIDEBentley Laboratories, LLC6edd51e5-1c42-4e66-b5ca-abfea2dad8f82024-12-27WarningsExact identifier
application number: M020
Tone Control Morning Cream SPF 15OCTOCRYLENE AND OCTISALATE CREAMBentley Laboratories, LLCb4e3cd1c-ae42-4995-a314-96d24d328e412024-12-27WarningsExact identifier
application number: M020
ZO Skin Health Sunscreen Plus Powder Broad-Spectrum SPF 45 (Light)ZINC OXIDEZO Skin Health, Inc.be25489e-c3bf-77c5-e053-2a95a90a30de2024-12-27WarningsExact identifier
application number: M020
COOLA Classic Body Sunscreen Tropical Coconut SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLC55ad5d2f-a855-491e-a287-13689f8abff12024-12-27WarningsExact identifier
application number: M020
RODAN and FIELDS UNBLEMISHTITANIUM DIOXIDE, ZINC OXIDEBentley Laboratories, LLC2b3b6b62-364f-4aba-8024-3a73752b4c562024-12-27WarningsExact identifier
application number: M020
Powerbright Moisturizer SPF 50OCTOCRYLENE, HOMOSALATE, AVOBENZONE, AND OCTISALATEDermalogica, LLC.02c731ee-c5cb-4158-9b1f-e826593c35262024-12-27WarningsExact identifier
application number: M020
INVISIBLE PHYSICAL DEFENSE SPF30ZINC OXIDEDermalogica, Inc.2e5e6861-25ea-4605-8e59-41d852c002b72024-12-27WarningsExact identifier
application number: M020
COOLA CLASSIC FACE SUNSCREEN Cucumber Broad Spectrum SPF 30AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENECOOLA LLCdec3b0d1-f06e-4acf-8ba2-64167e774abc2024-12-27WarningsExact identifier
application number: M020
Clearing Defense SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEDermalogica, Inc.2388ae53-0a61-43c0-8936-c639887a56492024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c5efde-42e3-e4fc-e063-6394a90a491d2024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c62206-d832-8d9a-e063-6394a90a4c692024-12-26WarningsExact identifier
application number: M020
Morphe SPF 30 Broad Spectrum Sunsetter SettingOCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATECOSMAX USA, CORPORATION0d34406f-9dd0-3909-e063-6394a90ab9f92024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c64cc0-be42-c210-e063-6394a90a6d9a2024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c61c42-edda-1ebd-e063-6294a90aee132024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c62206-d839-8d9a-e063-6394a90a4c692024-12-26WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
98132-021-02981320021022 g in 1 JAR (98132-021-02) 2 g2021-08-010000-00-00NoNoCurrent
98132-021-08981320021088 g in 1 JAR (98132-021-08) 8 g2021-08-010000-00-00NoNoCurrent
98132-021-7598132002175.75 g in 1 JAR (98132-021-75) 2021-08-010000-00-00NoNoCurrent