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

SPF 20 Loose Mineral Foundation by

Drug Labeling and Warnings

SPF 20 Loose Mineral Foundation by is a Otc medication manufactured, distributed, or labeled by Colorescience. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Titanium Dioxide 18.6%	Sunscreen
Zinc Oxide 5.9%	Sunscreen

Uses

• Helps prevent sunburn.
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

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

• Apply liberally 15 minutes before sun exposure. Works best on moisturized skin.
• Reapply:
  • After 80 minutes of swimming or sweating.
  • Immediately after towel drying.
  • At least every 2 hours.
• Children under 6 months: ask a doctor.
• 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.

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

• Protect this product from excessive heat and direct sun.

Questions or comments?

Call toll free 866.426.5673

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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.

INGREDIENTS AND APPEARANCE

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)