SPF 20 LOOSE MINERAL FOUNDATION- titanium dioxide and zinc oxide powder 
Colorescience

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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SPF 20 Loose Mineral Foundation

Drug Facts

Active ingredientsPurpose
Titanium Dioxide 18.6%Sunscreen
Zinc Oxide 5.9%Sunscreen

Uses

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 a doctor if rash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

Mica, Methicone, Calcium Silicate, Dimethicone, Triethoxycaprylylsilane, Sodium Sulfate, Bismuth Oxychloride (CI 77163), Chromium Oxide Greens (CI 77288), Iron Oxides (CI 77491, CI 77492, CI 77499)

Other information

Questions or comments?

Call toll free 866.426.5673

Manufactured by
Colorescience®
Carlsbad, CA 92011

PRINCIPAL DISPLAY PANEL - 6 g Tube Carton

colorescience®

LOOSE
MINERAL
FOUNDATION

Breathable formula
Self-dispensing brush
Water resistant
(80 minutes)

20
Broad Spectrum
SPF 20
Sunscreen

Net Wt. 6 g / 0.21 oz.

PRINCIPAL DISPLAY PANEL - 6 g Tube Carton
SPF 20 LOOSE MINERAL FOUNDATION 
titanium dioxide and zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68078-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide186 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide59 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Mica (UNII: V8A1AW0880)  
Bismuth Oxychloride (UNII: 4ZR792I587)  
Dimethicone (UNII: 92RU3N3Y1O)  
Methicone (20 CST) (UNII: 6777U11MKT)  
Triethoxycaprylylsilane (UNII: LDC331P08E)  
Calcium Silicate (UNII: S4255P4G5M)  
Chromic Oxide (UNII: X5Z09SU859)  
Sodium Sulfate (UNII: 0YPR65R21J)  
Ferric Oxide Red (UNII: 1K09F3G675)  
Ferrosoferric Oxide (UNII: XM0M87F357)  
Ferric Oxide Yellow (UNII: EX438O2MRT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68078-000-011 in 1 CARTON10/01/2015
16 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35210/01/2015
Labeler - Colorescience (128731929)

Revised: 11/2018
Document Id: e1ba7868-3116-4d14-8a1e-2d66066db705
Set id: 50ea65bc-80e7-4644-8cf3-d166cd2dfc04
Version: 2
Effective Time: 20181105
 
Colorescience