FDA.reportPublic FDA data

Sweat Mineral Foundation SPF 30

Manufacturer
Sweat Cosmetics, Inc. | Color Design Laboratory
Effective date
2020-09-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:29:22

Label at a glance#

ProductSweat Mineral Foundation SPF 30 Shade 100
Active ingredientZinc Oxide
Label structure14 sections

Dosage and administration

Apply generously and uniformly 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, or at least every 2 hours. Children under 6 months of age: ask a doctor. Avoid inhaling while applying the product.

Storage and handling

Protect the product in this container from excessive heat or direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 16%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

Helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only.

  • Do not use on damaged or broken skin.
  • When using this product, keep out of eyes. Rinse with water to remove.
  • Stop use and ask doctor if rash or irritation 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

Apply generously and uniformly 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, or at least every 2 hours. Children under 6 months of age: ask a doctor. Avoid inhaling while applying the product.

Other Information

STORAGE AND HANDLING SECTION

Protect the product in this container from excessive heat or direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Mica, Boron Nitride, Squalane, Silica, Bismuth Oxychloride, Caprylyl Glycol, Tocopherol, Phenoxyethanol, Lecithin, Isopentyldiol, Silybum Marianum Seed Extract, Rhodiola Rosea Root Extract, Propanediol, Water

  • May Contain: Titanium Dioxide (Cl 77891), Iron Oxides (Cl 77491, Cl 77492, Cl 77499)

Questions or Comments?

OTC - QUESTIONS SECTION

Call (844) 867-9328 or email info@sweatcosmetics.com

SPL UNCLASSIFIED SECTION

Dist. by Sweat Cosmetics, Inc. | Denver, CO 80210

PRINCIPAL DISPLAY PANEL - 12 g Jar Box - 100

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sweat™

FOR ACTIVE BEAUTY

100

MINERAL FOUNDATION SPF 30
WATER RESISTANT - 80 MIN

NET WT 0.4 OZ ℮ 12 g

PRINCIPAL DISPLAY PANEL - 12 g Jar Box - 100
PRINCIPAL DISPLAY PANEL - 12 g Jar Box - 100

PRINCIPAL DISPLAY PANEL - 12 g Jar Box - 200

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sweat™

FOR ACTIVE BEAUTY

200

MINERAL FOUNDATION SPF 30
WATER RESISTANT - 80 MIN

NET WT 0.4 OZ ℮ 12 g

PRINCIPAL DISPLAY PANEL - 12 g Jar Box - 200
PRINCIPAL DISPLAY PANEL - 12 g Jar Box - 200

PRINCIPAL DISPLAY PANEL - 12 g Jar Box - 300

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sweat™

FOR ACTIVE BEAUTY

300

MINERAL FOUNDATION SPF 30
WATER RESISTANT - 80 MIN

NET WT 0.4 OZ ℮ 12 g

PRINCIPAL DISPLAY PANEL - 12 g Jar Box - 300
PRINCIPAL DISPLAY PANEL - 12 g Jar Box - 300

PRINCIPAL DISPLAY PANEL - 12 g Jar Box - 400

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sweat™

FOR ACTIVE BEAUTY

400

MINERAL FOUNDATION SPF 30
WATER RESISTANT - 80 MIN

NET WT 0.4 OZ ℮ 12 g

PRINCIPAL DISPLAY PANEL - 12 g Jar Box - 400
PRINCIPAL DISPLAY PANEL - 12 g Jar Box - 400

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80449-100-012022-01-28C16284748780-1d6a99b39-46a6-a426-e053-dadaa90af4c2Sweat™ Mineral Foundation SPF 30
80449-100-022022-01-28C16284748780-1d6a99b39-46a6-a426-e053-dadaa90af4c2Sweat™ Mineral Foundation SPF 30
80449-100-032022-01-28C16284748780-1d6a99b39-46a6-a426-e053-dadaa90af4c2Sweat™ Mineral Foundation SPF 30
80449-200-012022-01-28C16284748780-1d6a99b39-46a6-a426-e053-dadaa90af4c2Sweat™ Mineral Foundation SPF 30
80449-200-022022-01-28C16284748780-1d6a99b39-46a6-a426-e053-dadaa90af4c2Sweat™ Mineral Foundation SPF 30
80449-200-032022-01-28C16284748780-1d6a99b39-46a6-a426-e053-dadaa90af4c2Sweat™ Mineral Foundation SPF 30
80449-300-012022-01-28C16284748780-1d6a99b39-46a6-a426-e053-dadaa90af4c2Sweat™ Mineral Foundation SPF 30
80449-300-022022-01-28C16284748780-1d6a99b39-46a6-a426-e053-dadaa90af4c2Sweat™ Mineral Foundation SPF 30
80449-300-032022-01-28C16284748780-1d6a99b39-46a6-a426-e053-dadaa90af4c2Sweat™ Mineral Foundation SPF 30
80449-400-012022-01-28C16284748780-1d6a99b39-46a6-a426-e053-dadaa90af4c2Sweat™ Mineral Foundation SPF 30
80449-400-022022-01-28C16284748780-1d6a99b39-46a6-a426-e053-dadaa90af4c2Sweat™ Mineral Foundation SPF 30
80449-400-032022-01-28C16284748780-1d6a99b39-46a6-a426-e053-dadaa90af4c2Sweat™ Mineral Foundation SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80449-100-01Sweat Mineral Foundation SPF 30 Shade 1001 in 1 BOXPOWDER11
80449-100-01Sweat Mineral Foundation SPF 30 Shade 1002.7 g in 1 CONTAINERPOWDER2.71
80449-100-02Sweat Mineral Foundation SPF 30 Shade 1002.7 g in 1 CONTAINERPOWDER2.71
80449-100-02Sweat Mineral Foundation SPF 30 Shade 1001 in 1 BOXPOWDER11
80449-100-03Sweat Mineral Foundation SPF 30 Shade 10012 g in 1 JARPOWDER121
80449-100-03Sweat Mineral Foundation SPF 30 Shade 1001 in 1 BOXPOWDER11
80449-200-01Sweat Mineral Foundation SPF 30 Shade 2001 in 1 BOXPOWDER11
80449-200-01Sweat Mineral Foundation SPF 30 Shade 2002.7 g in 1 CONTAINERPOWDER2.71
80449-200-02Sweat Mineral Foundation SPF 30 Shade 2002.7 g in 1 CONTAINERPOWDER2.71
80449-200-02Sweat Mineral Foundation SPF 30 Shade 2001 in 1 BOXPOWDER11
80449-200-03Sweat Mineral Foundation SPF 30 Shade 2001 in 1 BOXPOWDER11
80449-200-03Sweat Mineral Foundation SPF 30 Shade 20012 g in 1 JARPOWDER121
80449-300-01Sweat Mineral Foundation SPF 30 Shade 3002.7 g in 1 CONTAINERPOWDER2.71
80449-300-01Sweat Mineral Foundation SPF 30 Shade 3001 in 1 BOXPOWDER11
80449-300-02Sweat Mineral Foundation SPF 30 Shade 3001 in 1 BOXPOWDER11
80449-300-02Sweat Mineral Foundation SPF 30 Shade 3002.7 g in 1 CONTAINERPOWDER2.71
80449-300-03Sweat Mineral Foundation SPF 30 Shade 30012 g in 1 JARPOWDER121
80449-300-03Sweat Mineral Foundation SPF 30 Shade 3001 in 1 BOXPOWDER11
80449-400-01Sweat Mineral Foundation SPF 30 Shade 4001 in 1 BOXPOWDER11
80449-400-01Sweat Mineral Foundation SPF 30 Shade 4002.7 g in 1 CONTAINERPOWDER2.71
80449-400-02Sweat Mineral Foundation SPF 30 Shade 4002.7 g in 1 CONTAINERPOWDER2.71
80449-400-02Sweat Mineral Foundation SPF 30 Shade 4001 in 1 BOXPOWDER11
80449-400-03Sweat Mineral Foundation SPF 30 Shade 4001 in 1 BOXPOWDER11
80449-400-03Sweat Mineral Foundation SPF 30 Shade 40012 g in 1 JARPOWDER121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80449-100SWEAT MINERAL FOUNDATION SPF 30 SHADE 100 (ZINC OXIDE) POWDER SWEAT MINERAL FOUNDATION SPF 30 SHADE 200 (ZINC OXIDE) POWDER SWEAT MINERAL FOUNDATION SPF 30 SHADE 300 (ZINC OXIDE) POWDER SWEAT MINERAL FOUNDATION SPF 30 SHADE 400 (ZINC OXIDE) POWDER [SWEAT COSMETICS, INC.]1Legacy NDC, 6 package rows20200916_05d4baa5-6ff0-46ee-a76a-8767904a19cb.zip
80449-200SWEAT MINERAL FOUNDATION SPF 30 SHADE 100 (ZINC OXIDE) POWDER SWEAT MINERAL FOUNDATION SPF 30 SHADE 200 (ZINC OXIDE) POWDER SWEAT MINERAL FOUNDATION SPF 30 SHADE 300 (ZINC OXIDE) POWDER SWEAT MINERAL FOUNDATION SPF 30 SHADE 400 (ZINC OXIDE) POWDER [SWEAT COSMETICS, INC.]1Legacy NDC, 6 package rows20200916_05d4baa5-6ff0-46ee-a76a-8767904a19cb.zip
80449-300SWEAT MINERAL FOUNDATION SPF 30 SHADE 100 (ZINC OXIDE) POWDER SWEAT MINERAL FOUNDATION SPF 30 SHADE 200 (ZINC OXIDE) POWDER SWEAT MINERAL FOUNDATION SPF 30 SHADE 300 (ZINC OXIDE) POWDER SWEAT MINERAL FOUNDATION SPF 30 SHADE 400 (ZINC OXIDE) POWDER [SWEAT COSMETICS, INC.]1Legacy NDC, 6 package rows20200916_05d4baa5-6ff0-46ee-a76a-8767904a19cb.zip
80449-400SWEAT MINERAL FOUNDATION SPF 30 SHADE 100 (ZINC OXIDE) POWDER SWEAT MINERAL FOUNDATION SPF 30 SHADE 200 (ZINC OXIDE) POWDER SWEAT MINERAL FOUNDATION SPF 30 SHADE 300 (ZINC OXIDE) POWDER SWEAT MINERAL FOUNDATION SPF 30 SHADE 400 (ZINC OXIDE) POWDER [SWEAT COSMETICS, INC.]1Legacy NDC, 6 package rows20200916_05d4baa5-6ff0-46ee-a76a-8767904a19cb.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80449-10080449-100-01, 80449-100-02, 80449-100-03
80449-20080449-200-01, 80449-200-02, 80449-200-03
80449-30080449-300-01, 80449-300-02, 80449-300-03
80449-40080449-400-01, 80449-400-02, 80449-400-03

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 72 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
MICAV8A1AW0880IACT
BORON NITRIDE2U4T60A6YDIACT
SQUALANEGW89575KF9IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
BISMUTH OXYCHLORIDE4ZR792I587IACT
CAPRYLYL GLYCOL00YIU5438UIACT
TOCOPHEROLR0ZB2556P8IACT
PHENOXYETHANOLHIE492ZZ3TIACT
ISOPENTYLDIOL19NOL5474QIACT
MILK THISTLEU946SH95EEIACT
SEDUM ROSEUM ROOT3S5ITS5ULNIACT
PROPANEDIOL5965N8W85TIACT
WATER059QF0KO0RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
Zinc OxideSOI2LOH54ZACTIB
MICAV8A1AW0880IACT
BORON NITRIDE2U4T60A6YDIACT
SQUALANEGW89575KF9IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
BISMUTH OXYCHLORIDE4ZR792I587IACT
CAPRYLYL GLYCOL00YIU5438UIACT
TOCOPHEROLR0ZB2556P8IACT
PHENOXYETHANOLHIE492ZZ3TIACT
ISOPENTYLDIOL19NOL5474QIACT
MILK THISTLEU946SH95EEIACT
SEDUM ROSEUM ROOT3S5ITS5ULNIACT
PROPANEDIOL5965N8W85TIACT
WATER059QF0KO0RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
Zinc OxideSOI2LOH54ZACTIB
MICAV8A1AW0880IACT
BORON NITRIDE2U4T60A6YDIACT
SQUALANEGW89575KF9IACT

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
f2f1f894-f184-450f-a779-3e0ecc6f3e5105d4baa5-6ff0-46ee-a76a-8767904a19cb2020-09-11WarningsExact identifier
spl id: f2f1f894-f184-450f-a779-3e0ecc6f3e51
spl set id: 05d4baa5-6ff0-46ee-a76a-8767904a19cb

Reported adverse events (FAERS/openFDA)#

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