TINTED LIP CONDITIONER SPF 15- octinoxate, octisalate gel 
MAKEUP ART COSMETICS

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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ACTIVE INGREDIENTS: OCTINOXATE 7.50% [] OCTISALATE 5.00%


INACTIVE INGREDIENTS: PETROLATUM [] RICINUS COMMUNIS (CASTOR) SEED OIL [] POLYBUTENE [] MICROCRYSTALLINE WAX \CERA MICROCRISTALLINA\CIRE MICROCRISTALLINE [] ETHYLENE/PROPYLENE/STYRENE COPOLYMER [] HYDROGENATED POLYISOBUTENE [] FRAGRANCE (PARFUM) [] SILICA [] BUTYROSPERMUM PARKII (SHEA BUTTER) [] PERSEA GRATISSIMA (AVOCADO) OIL UNSAPONIFIABLES [] TRITICUM VULGARE (WHEAT) GERM OIL [] CHAMOMILLA RECUTITA (MATRICARIA) FLOWER OIL [] ASTROCARYUM MURUMURU BUTTER [] PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL [] TOCOPHERYL ACETATE [] RETINYL PALMITATE [] CHOLESTEROL [] LECITHIN [] SQUALANE [] POLYETHYLENE [] POLYDECENE [] BUTYLENE/ETHYLENE/STYRENE COPOLYMER [] TRIETHOXYCAPRYLYLSILANE [] TETRAHEXYLDECYL ASCORBATE [] SACCHARIN [] VANILLIN [] BHT

WARNING: STOP USE IF IRRITATION OCCURS.

PRINCIPAL DISPLAY PANEL:


MAC

LIP CONDITIONER SPF 15


15 ML/0.5 US FL OZ.



DISTR. BY MAKEUP ART COSMETICS
TORONTO, ONTARIO, CANADA, M5V 1R7


folding carton


TINTED LIP CONDITIONER  SPF 15
octinoxate, octisalate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40046-0049
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.0 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
CASTOR OIL (UNII: D5340Y2I9G)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POLYISOBUTYLENE (35000 MW) (UNII: 98553S1MHQ)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
ALMOND OIL (UNII: 66YXD4DKO9)  
SHEA BUTTER (UNII: K49155WL9Y)  
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
WHEAT GERM OIL (UNII: 14C97E680P)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
SACCHARIN (UNII: FST467XS7D)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:40046-0049-11 in 1 CARTON
1NDC:40046-0049-215 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/01/2010
Labeler - MAKEUP ART COSMETICS (010597206)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD205952385manufacture
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326manufacture
Establishment
NameAddressID/FEIBusiness Operations
Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aramis Inc.042918826manufacture
Establishment
NameAddressID/FEIBusiness Operations
Northtec Bristol949264774manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Northtec Keystone618107429manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics, Ltd.255175580manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics, Ltd253616536manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Distribution Center208579636repack, relabel
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Kabushiki Kaisha712808195relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Whitman Laboratories Ltd.216866277manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058manufacture

Revised: 9/2011
Document Id: f0d2beaa-423a-4249-9e76-fc10fb872ccb
Set id: 5006df08-636d-4633-991b-e2178369edaf
Version: 1
Effective Time: 20110912
 
MAKEUP ART COSMETICS