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

Sweat Mineral Foundation SPF 30 by

Drug Labeling and Warnings

Sweat Mineral Foundation SPF 30 by is a Otc medication manufactured, distributed, or labeled by Sweat Cosmetics, Inc., Color Design Laboratory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 - 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 - 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 - 400

sweat™

FOR ACTIVE BEAUTY

400

MINERAL FOUNDATION SPF 30
WATER RESISTANT - 80 MIN

NET WT 0.4 OZ ? 12 g

INGREDIENTS AND APPEARANCE

SWEAT MINERAL FOUNDATION SPF 30   SHADE 100
zinc oxide powder

Product 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 powder

Product 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 powder

Product 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 powder

Product 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)