Label: SWEAT 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

  • NDC Code(s): 80449-100-01, 80449-100-02, 80449-100-03, 80449-200-01, view more
    80449-200-02, 80449-200-03, 80449-300-01, 80449-300-02, 80449-300-03, 80449-400-01, 80449-400-02, 80449-400-03
  • Packager: Sweat Cosmetics, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 11, 2020

If you are a consumer or patient please visit this version.

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Zinc Oxide 16%

  • Purpose

    Sunscreen

  • Use

    Helps prevent sunburn

  • Warnings

    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.

    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    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

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

  • Inactive Ingredients

    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?

    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

    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 - 200

    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 - 300

    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 - 400

    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
  • INGREDIENTS AND APPEARANCE
    SWEAT MINERAL FOUNDATION SPF 30   SHADE 100
    zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80449-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide16 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    SQUALANE (UNII: GW89575KF9)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ISOPENTYLDIOL (UNII: 19NOL5474Q)  
    MILK THISTLE (UNII: U946SH95EE)  
    SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80449-100-011 in 1 BOX06/08/2015
    12.7 g in 1 CONTAINER; Type 0: Not a Combination Product
    2NDC:80449-100-021 in 1 BOX06/08/2015
    22.7 g in 1 CONTAINER; Type 0: Not a Combination Product
    3NDC:80449-100-031 in 1 BOX06/08/2015
    312 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35206/08/2015
    SWEAT MINERAL FOUNDATION SPF 30   SHADE 200
    zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80449-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide16 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    SQUALANE (UNII: GW89575KF9)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ISOPENTYLDIOL (UNII: 19NOL5474Q)  
    MILK THISTLE (UNII: U946SH95EE)  
    SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80449-200-011 in 1 BOX06/08/2015
    12.7 g in 1 CONTAINER; Type 0: Not a Combination Product
    2NDC:80449-200-021 in 1 BOX06/08/2015
    22.7 g in 1 CONTAINER; Type 0: Not a Combination Product
    3NDC:80449-200-031 in 1 BOX06/08/2015
    312 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35206/08/2015
    SWEAT MINERAL FOUNDATION SPF 30   SHADE 300
    zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80449-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide16 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    SQUALANE (UNII: GW89575KF9)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ISOPENTYLDIOL (UNII: 19NOL5474Q)  
    MILK THISTLE (UNII: U946SH95EE)  
    SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80449-300-011 in 1 BOX06/08/2015
    12.7 g in 1 CONTAINER; Type 0: Not a Combination Product
    2NDC:80449-300-021 in 1 BOX06/08/2015
    22.7 g in 1 CONTAINER; Type 0: Not a Combination Product
    3NDC:80449-300-031 in 1 BOX06/08/2015
    312 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35206/08/2015
    SWEAT MINERAL FOUNDATION SPF 30   SHADE 400
    zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80449-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide16 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    SQUALANE (UNII: GW89575KF9)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ISOPENTYLDIOL (UNII: 19NOL5474Q)  
    MILK THISTLE (UNII: U946SH95EE)  
    SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80449-400-011 in 1 BOX06/08/2015
    12.7 g in 1 CONTAINER; Type 0: Not a Combination Product
    2NDC:80449-400-021 in 1 BOX06/08/2015
    22.7 g in 1 CONTAINER; Type 0: Not a Combination Product
    3NDC:80449-400-031 in 1 BOX06/08/2015
    312 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35206/08/2015
    Labeler - Sweat Cosmetics, Inc. (088620654)
    Establishment
    NameAddressID/FEIBusiness Operations
    Color Design Laboratory837941108MANUFACTURE(80449-100, 80449-200, 80449-300, 80449-400)
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