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 ingredients Purpose
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 Type HUMAN OTC DRUG Item Code (Source) NDC:68078-000
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 186 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 59 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:68078-000-01 1 in 1 CARTON 10/01/2015
1 6 g in 1 TUBE, WITH APPLICATOR; 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 10/01/2015
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