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 more80449-200-02, 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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Use
- Warnings
- Directions
- Other Information
- Inactive Ingredients
- Questions or Comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 12 g Jar Box - 100
- PRINCIPAL DISPLAY PANEL - 12 g Jar Box - 200
- PRINCIPAL DISPLAY PANEL - 12 g Jar Box - 300
- PRINCIPAL DISPLAY PANEL - 12 g Jar Box - 400
-
INGREDIENTS AND APPEARANCE
SWEAT MINERAL FOUNDATION SPF 30 SHADE 100
zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80449-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 16 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:80449-100-01 1 in 1 BOX 06/08/2015 1 2.7 g in 1 CONTAINER; Type 0: Not a Combination Product 2 NDC:80449-100-02 1 in 1 BOX 06/08/2015 2 2.7 g in 1 CONTAINER; Type 0: Not a Combination Product 3 NDC:80449-100-03 1 in 1 BOX 06/08/2015 3 12 g in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 06/08/2015 SWEAT MINERAL FOUNDATION SPF 30 SHADE 200
zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80449-200 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 16 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:80449-200-01 1 in 1 BOX 06/08/2015 1 2.7 g in 1 CONTAINER; Type 0: Not a Combination Product 2 NDC:80449-200-02 1 in 1 BOX 06/08/2015 2 2.7 g in 1 CONTAINER; Type 0: Not a Combination Product 3 NDC:80449-200-03 1 in 1 BOX 06/08/2015 3 12 g in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 06/08/2015 SWEAT MINERAL FOUNDATION SPF 30 SHADE 300
zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80449-300 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 16 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:80449-300-01 1 in 1 BOX 06/08/2015 1 2.7 g in 1 CONTAINER; Type 0: Not a Combination Product 2 NDC:80449-300-02 1 in 1 BOX 06/08/2015 2 2.7 g in 1 CONTAINER; Type 0: Not a Combination Product 3 NDC:80449-300-03 1 in 1 BOX 06/08/2015 3 12 g in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 06/08/2015 SWEAT MINERAL FOUNDATION SPF 30 SHADE 400
zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80449-400 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 16 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:80449-400-01 1 in 1 BOX 06/08/2015 1 2.7 g in 1 CONTAINER; Type 0: Not a Combination Product 2 NDC:80449-400-02 1 in 1 BOX 06/08/2015 2 2.7 g in 1 CONTAINER; Type 0: Not a Combination Product 3 NDC:80449-400-03 1 in 1 BOX 06/08/2015 3 12 g in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 06/08/2015 Labeler - Sweat Cosmetics, Inc. (088620654) Establishment Name Address ID/FEI Business Operations Color Design Laboratory 837941108 MANUFACTURE(80449-100, 80449-200, 80449-300, 80449-400)