CLARINS BROAD SPECTRUM SPF 15 EVERLASTING FOUNDATION TINT 109- titanium dioxide liquid

CLARINS Broad Spectrum SPF 15 Everlasting Foundation Tint 109 by

Drug Labeling and Warnings

CLARINS Broad Spectrum SPF 15 Everlasting Foundation Tint 109 by is a Otc medication manufactured, distributed, or labeled by Laboratoires Clarins S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

TITANIUM DIOXIDE 2%

Purpose

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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions:

apply liberally 15 minutes before sun exposure
apply to all skin exposed to the sun
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 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
use a water resistant sunscreen if swimming or sweating.

Inactive ingredients

AQUA/WATER/EAU - CYCLOMETHICONE - CYCLOPENTASILOXANE - HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER -  SODODECANE - BUTYLENE GLYCOL - ALCOHOL - NYLON-12 - PEG/PPG-20/15 DIMETHICONE - MAGNESIUM SULFATE - PEG-10 DIMETHICONE - POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE - METHYL TRIMETHICONE - PARFUM/FRAGRANCE - POLYGLYCERYL- 3 DIISOSTEARATE - DISODIUM STEAROYL GLUTAMATE - ALUMINUM HYDROXIDE - ACRYLATES/DIMETHICONE COPOLYMER - STEARIC ACID - DIDISTEARDIMONIUM HECTORITE - ETHYLHEXYLGLYCERIN - SILICA - DISODIUM EDTA - HYDROXYETHYL UREA - SORBIC ACID - CAMELLIA SINENSIS LEAF EXTRACT - PHENOXYETHANOL - ALGIN - ACACIA SENEGAL GUM.

± / MAY CONTAIN/PEUT CONTENIR: [CI 77891/TITANIUM DIOXIDE . CI 77491/CI 77492/CI 77499/IRON OXIDES]. [M1922A]

Other information:

protect this product from excessive heat and direct sun.

Questions or comments?

Call 1-866-252-7467 Monday-Friday, 8 a.m. to 5 p.m.

CLARINS

Simply everlasting: 15 hours of impeccable coverage and total comfort thanks to a non-oily, melting, smoothing texture which evens tone and enhances the complexion. For a flawless complexion under any circumstances. Matte finish. Full coverage. All skin types. Oil-free. Non-comedogenic. Dermatologist tested.  www.clarins.com  CLARINS PARIS 92200 Neuilly 95300 Pontoise - France Made in France

PRINCIPAL DISPLAY PANEL

CLARINS PARIS  109 Teint Haute Tenue Broad Spectrum SPF 15 Titanium Dioxide - Sunscreen Everlasting Foundation e 30 mL 1.2 Oz. Net Wt.

Product Labels

INGREDIENTS AND APPEARANCE

CLARINS BROAD SPECTRUM SPF 15 EVERLASTING FOUNDATION TINT 109 
titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58668-2191
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISODODECANE (UNII: A8289P68Y2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALCOHOL (UNII: 3K9958V90M)
NYLON-12 (UNII: 446U8J075B)
PEG/PPG-20/15 DIMETHICONE (UNII: 06R6X77P9C)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
SORBIC ACID (UNII: X045WJ989B)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ACACIA (UNII: 5C5403N26O)
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: 58668-2191-1	1 in 1 PACKAGE	02/08/2013
1		30 mL in 1 BOTTLE, PUMP; 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	02/08/2013

Labeler - Laboratoires Clarins S.A. (266317555)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoires Clarins S.A.		266317555	manufacture(58668-2191)