SWEAT GLOW HARD BRONZER SPF 25- zinc oxide powder

Sweat Glow Hard Bronzer SPF 25 by

Drug Labeling and Warnings

Sweat Glow Hard Bronzer SPF 25 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 12%

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 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

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 - 2.7 g Container Box

sweat™

FOR ACTIVE BEAUTY

GLOW HARD

MINERAL BRONZER SPF 25
WATER RESISTANT - 40 MIN
+
1 TWIST-BRUSH

NET WT 0.09 OZ e 2.7 g

INGREDIENTS AND APPEARANCE

SWEAT GLOW HARD BRONZER SPF 25 
zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80449-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	12 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: 80449-003-01	1 in 1 BOX	07/27/2016
1		2.7 g in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC: 80449-003-02	1 in 1 BOX	07/27/2016
2		2.7 g in 1 CONTAINER; 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	07/27/2016

Labeler - Sweat Cosmetics, Inc. (088620654)

Establishment
Name	Address	ID/FEI	Business Operations
Color Design Laboratory		837941108	MANUFACTURE(80449-003)