NATURAL FINISH PRESSED FOUNDATION SPF 20 SUNSCREEN- titanium dioxide and zinc oxide powder

Natural Finish Pressed Foundation SPF 20 Sunscreen by

Drug Labeling and Warnings

Natural Finish Pressed Foundation SPF 20 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Colorescience. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Titanium Dioxide 21.2%	Sunscreen
Zinc Oxide 12.1%	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

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, Ethylhexyl Hydroxystearate Benzoate, Tocopheryl Acetate, Daucus Carota Sativa (Carrot) Seed Oil, Glycerin, Methicone, Dimethicone, Triethoxycaprylylsilane, Lycopodium Clavatum Extract, Imperata Cylindrica Root Extract, Lauroyl Lysine, Silica, Pelargonium Graveolens Flower Oil, Cananga Odorata Flower Oil, Fusanus Spicatus Wood Oil, Phenethyl Alcohol, Sodium Dehydroacetate, Caprylyl Glycol, Phenoxyethanol, Potassium Sorbate, Benzyl Benzoate, Farnesol, Linalool, 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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Distributed in USA by
Colorescience®
Carlsbad, CA 92011

PRINCIPAL DISPLAY PANEL - 12 g Container Carton

colorescience®

NATURAL FINISH
PRESSED FOUNDATION

Breathable formula, buildable coverage

Vitamin and antioxidant infused

Water resistant (80 minutes)

20
Broad Spectrum
SPF 20
Sunscreen

Net Wt. 12 g / 0.42 oz.

INGREDIENTS AND APPEARANCE

NATURAL FINISH PRESSED FOUNDATION SPF 20 SUNSCREEN 
titanium dioxide and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68078-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	212 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	120 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Mica (UNII: V8A1AW0880)
BENZYL BENZOATE (UNII: N863NB338G)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Carrot Seed Oil (UNII: 595AO13F11)
Glycerin (UNII: PDC6A3C0OX)
Methicone (20 Cst) (UNII: 6777U11MKT)
Dimethicone (UNII: 92RU3N3Y1O)
Triethoxycaprylylsilane (UNII: LDC331P08E)
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479)
Imperata Cylindrica Root (UNII: VYT2JA85NH)
Lauroyl Lysine (UNII: 113171Q70B)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Pelargonium Graveolens Flower Oil (UNII: 3K0J1S7QGC)
Cananga Oil (UNII: 8YOY78GNNX)
Santalum Spicatum Oil (UNII: H9LVS6REV4)
Phenylethyl Alcohol (UNII: ML9LGA7468)
Sodium Dehydroacetate (UNII: 8W46YN971G)
Caprylyl Glycol (UNII: 00YIU5438U)
Phenoxyethanol (UNII: HIE492ZZ3T)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Bismuth Oxychloride (UNII: 4ZR792I587)
Chromic Oxide (UNII: X5Z09SU859)
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: 68078-013-14	1 in 1 CARTON	09/01/2016
1		12 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	09/01/2016

Labeler - Colorescience (128731929)