DailyMed - 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

Contains inactivated NDC Code(s)
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.

Download DRUG LABEL INFO: PDF XML
Official Label (Printer Friendly)

View All Sections

SPL UNCLASSIFIED SECTION
Drug Facts

Drug Facts
Close
Active Ingredients
Zinc Oxide 16%

Zinc Oxide 16%
Close
Purpose
Sunscreen

Sunscreen
Close
Use
Helps prevent sunburn

Helps prevent sunburn
Close
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 ...
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.
Close
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 ...

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

Protect the product in this container from excessive heat or direct sun.
Close
Inactive Ingredients
Mica, Boron Nitride, Squalane, Silica, Bismuth Oxychloride, Caprylyl Glycol, Tocopherol, Phenoxyethanol, Lecithin, Isopentyldiol, Silybum Marianum Seed Extract, Rhodiola Rosea Root Extract ...
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)
Close
Questions or Comments?
Call (844) 867-9328 or email info@sweatcosmetics.com

Call (844) 867-9328 or email info@sweatcosmetics.com
Close
SPL UNCLASSIFIED SECTION
Dist. by Sweat Cosmetics, Inc. | Denver, CO 80210

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

sweat™

FOR ACTIVE BEAUTY

100

MINERAL FOUNDATION SPF 30
WATER RESISTANT - 80 MIN

NET WT 0.4 OZ ? 12 g

Close
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

sweat™

FOR ACTIVE BEAUTY

200

MINERAL FOUNDATION SPF 30
WATER RESISTANT - 80 MIN

NET WT 0.4 OZ ? 12 g

Close
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

sweat™

FOR ACTIVE BEAUTY

300

MINERAL FOUNDATION SPF 30
WATER RESISTANT - 80 MIN

NET WT 0.4 OZ ? 12 g

Close
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

sweat™

FOR ACTIVE BEAUTY

400

MINERAL FOUNDATION SPF 30
WATER RESISTANT - 80 MIN

NET WT 0.4 OZ ? 12 g

Close

INGREDIENTS AND APPEARANCE

Product Information

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	16 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	16 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	16 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	16 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	06/08/2015

Labeler - Sweat Cosmetics, Inc. (088620654)

Name	Address	ID/FEI	Business Operations
Establishment
Color Design Laboratory		837941108	MANUFACTURE(80449-100, 80449-200, 80449-300, 80449-400)

View All Sections

	NDC
1	80449-100-01 (inactivated)
2	80449-100-02 (inactivated)
3	80449-100-03 (inactivated)
4	80449-200-01 (inactivated)
5	80449-200-02 (inactivated)
6	80449-200-03 (inactivated)
7	80449-300-01 (inactivated)
8	80449-300-02 (inactivated)
9	80449-300-03 (inactivated)
10	80449-400-01 (inactivated)
11	80449-400-02 (inactivated)
12	80449-400-03 (inactivated)

View Package Photos

VIEW MORE

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Find additional resources

Safety

Related Resources

More Info on this Drug

View Package Photos

VIEW MORE

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Find additional resources

Safety

Related Resources

More Info on this Drug

Number of versions: 1

To receive this label RSS feed

To receive all DailyMed Updates for the last seven days

What will I get with the DailyMed RSS feed?

How to discontinue the RSS feed

Why is DailyMed no longer displaying pill images on the Search Results and Drug Info pages?

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.