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Name:Vitalumiere Aquaspf 15
Manufacturer:Chanel Parfums Beaute
Category:Over-the-counter (OTC) Marketed Drugs


DRUG FACTS

VITALUMIERE AQUA SPF 15 - octinoxate and titanium dioxide liquid 
CHANEL PARFUMS BEAUTE

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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DRUG FACTS

ACTIVE INGREDIENT(S)

OCTINOXATE 6%

TITANIUM DIOXIDE 5.6%


WARNINGS

FOR EXTERNAL USE ONLY.  NOT TO BE SWALLOWED.  AVOID CONTACT WITH EYES.  IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER.  DISCONTINUE USE IF SIGNS OF IRRITATION APPEAR.  IF IRRITATION PERSISTS, CONSULT A DOCTOR.  KEEP OUT OF REACH OF CHILDREN.  DO NOT USE ON INFANTS UNDER THE AGE OF SIX MONTHS. 

DIRECTIONS FOR USE

APPLY WITH FINGERTIPS OR FOUNDATION BRUSH AND BLEND GENTLY. 

INACTIVE INGREDIENTS

AQUA (WATER), METHYL TRIMETHICONE, ALCOHOL, DIMETHICONE, PHENYL TRIMETHICONE, TALC, BUTYLENE GLYCOL, ISODODECANE, POLYMETHYLSILSESQUIOXANE, ACRYLATES/POLYTRIMETHYLSILOXYMETHACRYLATE COPOLYMER, POLYMETHYL METHACRYLATE, PEG-10 DIMETHICONE, STEARIC ACID, DIMETHICONE/PEG-10/15 CROSSPOLYMER, ALUMINA, ALUMINUM HYDROXIDE, PHENOXYETHANOL, C9-15 FLUOROALCOHOL PHOSPHATE, MAGNESIUM SULFATE, PARFUM (FRAGRANCE), NELUMBO NUCIFERA FLOWER WATER, METHYLPARABEN, TRIETHOXYCAPRYLYLSILANE, SODIUM HYALURONATE, SILICA, TOCOPHERYL ACETATE, DIPROPYLENE GLYCOL, POLYURETHANE-15, BHT, LAMINARIA DIGITATA EXTRACT, TOCOPHEROL, PROPYLPARABEN, ETHYLPARABEN [+/-(MAY CONTAIN) CI 77007 (ULTRAMARINES), CI 77491, CI77492, CI 77499 (IRON OXIDES), CI 77891 (TITANIUM DIOXIDE), MICA]

PRINCIPAL DISPLAY PANEL

VITALUMIERE AQUA

ULTRA-LIGHT

SKIN PERFECTING MAKEUP

INSTANT NATURAL RADIANCE

SPF 15

(SHADE)

CHANEL

30 ML  1 FL.OZ.

IMAGE OF CARTON



VITALUMIERE AQUA  SPF 15
ultra-light skin perfecting makeup liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68745-1152
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 1.8 mL  in 30 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 1.68 mL  in 30 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68745-1152-2 1 BOTTLE, GLASS ( BOTTLE) in 1 CARTON contains a BOTTLE, GLASS (68745-1152-1)
1 NDC:68745-1152-1 30 mL in 1 BOTTLE, GLASS This package is contained within the CARTON (68745-1152-2)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 02/01/2011

Labeler - CHANEL PARFUMS BEAUTE (275137669)
Establishment
Name Address ID/FEI Operations
CHANEL PARFUMS BEAUTE 277032509 manufacture

Revised: 08/2010 CHANEL PARFUMS BEAUTE



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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