SWEAT GLEAM ON MINERAL ILLUMINATOR SPF 25- zinc oxide powder 
Sweat Cosmetics, Inc.

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.

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Sweat™ Gleam On Mineral Illuminator SPF 25

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.

Direction

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

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

PRINCIPAL DISPLAY PANEL - 2.7 g Container Box

sweat™

FOR ACTIVE BEAUTY

GLEAM ON

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

NET WT 0.09 OZ ? 2.7 g

PRINCIPAL DISPLAY PANEL - 2.7 g Container Box
SWEAT GLEAM ON MINERAL ILLUMINATOR SPF 25 
zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80449-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12 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:80449-004-011 in 1 BOX07/27/2016
12.7 g in 1 CONTAINER; Type 0: Not a Combination Product
2NDC:80449-004-021 in 1 BOX07/27/2016
22.7 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35207/27/2016
Labeler - Sweat Cosmetics, Inc. (088620654)
Establishment
NameAddressID/FEIBusiness Operations
Color Design Laboratory837941108MANUFACTURE(80449-004)

Revised: 9/2020
Document Id: 62cd2dcc-850c-42b5-84b3-316906f23185
Set id: dfe96f0a-92e3-47a3-82d4-d9e2b52b108d
Version: 1
Effective Time: 20200911
 
Sweat Cosmetics, Inc.