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


DRUG FACTS

VITALUMIERE SPF 15 - octinoxate emulsion 
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 5%

WARNINGS

WARNING:  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 OCCUR.

DIRECTIONS FOR USE

APPLY WITH FINGERTIPS OR FOUNDATION BRUSH AND BLEND GENTLY.

INACTIVE INGREDIENTS

AQUA (WATER), ETHYLHEXYL PALMITATE, NEOPENTYL GLYCOL DIETHYLHEXANOATE, CYCLOPENTASILOXANE, TALC, CAPRYLIC/CAPRIC TRIGLYCERIDE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, PROPYLENE GLYCOL, GLYCERIN, PEG-30 DIPOLYHYDROXYSTEARATE, BUTYLENE GLYCOL, PHENOXYETHANOL, PARFUM (FRAGRANCE), METHYLPARABEN, DISTEARDIMONIUM HECTORITE, POLYGLYCERYL-3 BEESWAX, DISODIUM STEAROYL GLUTAMATE, PROPYLPARABEN, LECITHIN, TOCOPHEROL, ASCORBYL PALMITATE, GLYCERYL STEARATE, ALCOHOL, JUGLANS REGIA (WALNUT) SEED EXTRACT, SILICA, LAMINARIA DIGITATA EXTRACT, GLYCERYL OLEATE, SODIUM HYALURONATE, ALUMINUM HYDROXIDE, CITRIC ACID, SODIUM METABISULFITE, BHT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, ETHYLPARABEN, DENATONIUM BENZOATE [+/-(MAY CONTAIN) CI 77007 (ULTRAMARINES), CI 77491, CI 77492, CI 77499 (IRON OXIDES), CI 77891 (TITANIUM DIOXIDE), MICA]

PRINCIPAL DISPLAY PANEL

VITALUMIERE

MOISTURE-RICH

RADIANCE

FLUID MAKEUP

SPF 15

(SHADE)

CHANEL

30 ML   1 FL.OZ.

Image of Carton


VITALUMIERE  SPF 15
moisture-rich fluid makeup emulsion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68745-1145
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate (Octinoxate) Octinoxate 1.5 mL  in 30 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68745-1145-2 1 BOTTLE, PUMP ( BOTTLE) in 1 CARTON contains a BOTTLE, PUMP (68745-1145-1)
1 NDC:68745-1145-1 30 mL in 1 BOTTLE, PUMP This package is contained within the CARTON (68745-1145-2)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 03/01/2010

Labeler - CHANEL PARFUMS BEAUTE (275137669)
Establishment
Name Address ID/FEI Operations
CHANEL PARFUMS BEAUTE 277032517 manufacture

Revised: 01/2010 CHANEL PARFUMS BEAUTE



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


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