STUDIO FINISH CONCEALER SPF 35- octinoxate, titanium dioxide paste 
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 5.00% [] TITANIUM DIOXIDE 2.00%

INACTIVE INGREDIENTS: OCTYLDODECANOL [] SYNTHETIC BEESWAX [] COPERNICIA CERIFERA (CARNAUBA) WAX [] SILICA [] HYDROGENATED POLYISOBUTENE [] SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL [] TOCOPHEROL [] ASCORBYL PALMITATE [] POLYBUTENE [] PVP/HEXADECENE COPOLYMER [] ALUMINA [] STEARIC ACID []  [+/-(MAY CONTAIN) TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] CHROMIUM OXIDE GREENS (CI 77288)]

WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS. KEEP OUT OF REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL


MAC

STUDIO FINISH CONCEALER

SPF 35



NET WT. 7 g/ 0.24 oz



MAKE UP ART COSMETICS

TORONTO, ONTARIO, CANADA,M5V 1R7

FOLDING CARTON


STUDIO FINISH CONCEALER  SPF 35
octinoxate, titanium dioxide paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40046-0048
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5.0 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.00 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
OCTYLDODECANOL (UNII: 461N1O614Y)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
JOJOBA OIL (UNII: 724GKU717M)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
CHROMIC OXIDE (UNII: X5Z09SU859)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:40046-0048-11 in 1 CARTON
1NDC:40046-0048-27 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/01/2003
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: 8/2011
Document Id: c0ed0ee1-0b8a-4e11-aec8-dfc9d6b56ab4
Set id: 951163a3-b22f-4027-97ed-946aceb43762
Version: 1
Effective Time: 20110826
 
MAKEUP ART COSMETICS