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


DRUG FACTS

AQUALUMIERE SPF 15 - avobenzone and octinoxate lipstick 
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  1%

OCTINOXATE  7.5%


WARNINGS

FOR EXTERNAL USE ONLY.  NOT TO BE SWALLOWED.  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 EVENLY TO LIPS.

INACTIVE INGREDIENTS

OCTYLDODECANOL, HYDROGENATED POLYDECENE, DIISOSTEARYL MALATE, SYNTHETIC WAX, TRIDECYL TRIMELLITATE, DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE/HEXASTEARATE/HEXAROSINATE, SUCROSE TETRASTEARATE TRIACETATE, POLYBUTENE, CALCIUM ALUMINUM BOROSILICATE, POLYETHYLENE, VP/HEXADECEN COPOLYMER, HYDROGENATED PALM KERNEL GLYCERIDES, CERA ALBA (BEESWAX), BUTYROSPERMUM PARKII (SHEA BUTTER), DISTEARDIMONIUM HECTORITE, SILICA, ETHYLHEXYL PALMITATE, TOCOPHERYL ACETATE, HYDROGENATED PALM GLYCERIDES, PROPYLENE CARBONATE, PHYTANTRIOL, TRIBEHENIN, PEG-8, PROPYLPARABEN, SORBITAN ISOSTEARATE, TIN OXIDE, ALUMINA, TOCOPHEROL, BHT, ASCORBYL PALMITATE, ASCORBIC ACID, CITRIC ACID, PALMITOYL OLIGOPEPTIDE [+/- (MAY CONTAIN) CI 12085 (RED 36), CI 15850 (RED 6), CI 15850 (RED 7 LAKE), CI 15985 (YELLOW 6 LAKE), CI 17200 (RED 33 LAKE), CI 19140 (YELLOW 5 LAKE), CI 42090 (BLUE 1 LAKE), CI 45380 (RED 22 LAKE), CI 45410 (RED 28 LAKE) CI 14005 (YELLOW 10 LAKE), CI 73360 (RED 30 LAKE), CI 75470 (CARMINE), CI 77163 (BISMUTH OXYCHLORIDE), CI 77400 (COPPER POWDER), CI 77491, CI 77492, CI 77499 (IRON OXIDES), CI 77742 (MANGANESE VIOLET), CI 77891 (TITANIUM DIOXIDE), MICA]

PRINCIPAL DISPLAY PANEL

AQUALUMIERE

SHEER COLOUR

LIPSHINE

SPF 15

(SHADE)

CHANEL

POIDS NET 3,5g  NET WT. 0.12 OZ.

IMAGE OF CARTON


AQUALUMIERE  SPF 15
sheer colour lipshine lipstick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68745-1101
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE .035 g  in 3.5 g
OCTINOXATE (OCTINOXATE) OCTINOXATE .2625 g  in 3.5 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68745-1101-2 1 TUBE ( TUBE) in 1 CARTON contains a TUBE (68745-1101-1)
1 NDC:68745-1101-1 3.5 g in 1 TUBE This package is contained within the CARTON (68745-1101-2)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 04/01/2004

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