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


DRUG FACTS

BEAUTE INITIALE SPF 15 - avobenzone and 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)

AVOBENZONE 2%

OCTINOXATE 7.5%


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 TO THOROUGHLY CLEANSED SKIN, SMOOTHING OVER FACE AND NECK.

INACTIVE INGREDIENTS

AQUA (WATER), CYCLOHEXASILOXANE, ALCOHOL, GLYCERIN, SILICA, PEG-5 RAPESEED STEROL, ETHYLHEXYL PALMITATE, LAURETH-23, PPG-12/SMDI COPOLYMER, JOJOBA ESTERS, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, CYCLOPENTASILOXANE, PROPYLENE GLYCOL, METHYLPARABEN, PARFUM (FRAGRANCE), POLYMETHYL METHACRYLATE, BUTYLENE GLYCOL, CAPRYLYL GLYCOL, XANTHAN GUM, AMMONIUM GLYCYRRHIZATE, DIMETHICONE, DISODIUM EDTA, LAUROYL LYSINE, MANGANESE GLUCONATE, PEG-12, MAGNESIUM ASPARTATE, ZINC GLUCONATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, PENTAERYTHYRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, TOCOPHEROL, SODIUM CARBOMER, ASCORBYL TETRAISOPALMITATE, PHENOXYETHANOL, BHT, COPPER GLUCONATE, ETHYLPARABEN, PROPYLPARABEN, SODIUM DNA, CI 17200 (RED 33), CI 77891 (TITANIUM DIOXIDE), MICA

PRINCIPAL DISPLAY PANEL

BEAUTE INITIALE

ENERGIZING MULTI-PROTECTION FLUID

SPF 15

PRECISION

CHANEL

50 ML  1.7 FL.OZ.

Image of Carton


BEAUTE INITIALE  SPF 15
energizing multi-protection fluid emulsion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68745-1126
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 1 mL  in 50 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE 3.75 mL  in 7.5 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68745-1126-2 1 BOTTLE, PUMP ( BOTTLE) in 1 CARTON contains a BOTTLE, PUMP (68745-1126-1)
1 NDC:68745-1126-1 50 mL in 1 BOTTLE, PUMP This package is contained within the CARTON (68745-1126-2)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 07/01/2008

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

Revised: 03/2010 CHANEL PARFUMS BEAUTE



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


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