AQUALUMIERE SPF 15

Dosage form: lipstick
Ingredients: AVOBENZONE .035g in 3.5g, OCTINOXATE .2625g in 3.5g
Labeler: CHANEL PARFUMS BEAUTE
NDC Code: 68745-1101

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.

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.

AQUALUMIERE  SPF 15
sheer colour lipshine lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68745-1101
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE.035 g  in 3.5 g
OCTINOXATE (OCTINOXATE) OCTINOXATE.2625 g  in 3.5 g
Packaging
#Item CodePackage Description
1NDC:68745-1101-21 TUBE (TUBE) in 1 CARTON
1NDC:68745-1101-13.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/01/2004
Labeler - CHANEL PARFUMS BEAUTE (275137669)
Establishment
NameAddressID/FEIOperations
CHANEL PARFUMS BEAUTE277032509manufacture

Revised: 03/2010
 
CHANEL PARFUMS BEAUTE

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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