FDA.reportPublic FDA data

Sweat Translucent Mineral BS SPF 30

Manufacturer
Sweat Cosmetics, Inc. | Color Design Laboratory
Effective date
2020-09-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:29:22

Label at a glance#

ProductSweat Translucent Mineral BS SPF 30
Active ingredientZinc Oxide
Label structure11 sections

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 20%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

Helps prevent sunburn

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED 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 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.

Direction

DOSAGE & ADMINISTRATION SECTION

Apply generously and uniformly 15 minutes before sun exposure. Reapply after 40 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.

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 value 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.
  • reapply at least every 2 hours.

Other Information

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Mica, Silica, Squalane, Boron Nitride, 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 - 2.7 g Container Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sweat™

FOR ACTIVE BEAUTY

BROAD SPECTRUM SPF 30
TRANSLUCENT MINERAL POWDER
WATER RESISTANT - 40 MIN
+
1 TWIST-BRUSH

NET WT 0.09 OZ e 2.7 g

Principal Display Panel - 2.7 g Container Box
Principal Display Panel - 2.7 g Container Box

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80449-001-012022-01-28C16284748780-1d6a99b39-60bb-a426-e053-dadaa90af4c2Sweat™ Translucent Mineral BS SPF 30
80449-001-022022-01-28C16284748780-1d6a99b39-60bb-a426-e053-dadaa90af4c2Sweat™ Translucent Mineral BS SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80449-001-01Sweat Translucent Mineral BS SPF 301 in 1 BOXPOWDER11
80449-001-01Sweat Translucent Mineral BS SPF 302.7 g in 1 CONTAINERPOWDER2.71
80449-001-02Sweat Translucent Mineral BS SPF 302.7 g in 1 CONTAINERPOWDER2.71
80449-001-02Sweat Translucent Mineral BS SPF 301 in 1 BOXPOWDER11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80449-001SWEAT TRANSLUCENT MINERAL BS SPF 30 (ZINC OXIDE) POWDER [SWEAT COSMETICS, INC.]1Legacy NDC, 4 package rows20200916_37eba4ea-96d1-4b4d-80b6-eb6a1562d7ae.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80449-00180449-001-01, 80449-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
MicaV8A1AW0880IACT
Silicon DioxideETJ7Z6XBU4IACT
Boron Nitride2U4T60A6YDIACT
Bismuth Oxychloride4ZR792I587IACT
Caprylyl Glycol00YIU5438UIACT
TocopherolR0ZB2556P8IACT
PhenoxyethanolHIE492ZZ3TIACT
Isopentyldiol19NOL5474QIACT
Milk ThistleU946SH95EEIACT
Sedum Roseum Root3S5ITS5ULNIACT
Propanediol5965N8W85TIACT
Water059QF0KO0RIACT
Titanium Dioxide15FIX9V2JPIACT
Ferric Oxide Red1K09F3G675IACT
Ferric Oxide YellowEX438O2MRTIACT
Ferrosoferric OxideXM0M87F357IACT

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
671158d2-d2b1-4370-8789-efbee38a560137eba4ea-96d1-4b4d-80b6-eb6a1562d7ae2020-09-14WarningsExact identifier
spl id: 671158d2-d2b1-4370-8789-efbee38a5601
spl set id: 37eba4ea-96d1-4b4d-80b6-eb6a1562d7ae

Reported adverse events (FAERS/openFDA)#

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