STUDIO FOUNDATION SPF 15- octinoxate and titanium dioxide stick 
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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STUDIO STICK FOUNDATION SPF 15

WARNING

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

ACTIVE INGREDIENTS

OCTINOXATE 5.00%, TITANIUM DIOXIDE 2.90%

INGREDIENTS

DI-PPG-3-MYRISTYL ETHER ADIPATE, PHENYL TRIMETHICONE, SILICA, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, DIMETHICONE, TRIBEHENIN, C20-40 ALCOHOLS, ISONONYL ISONONANOATE, OZOKERITE, ALOE BARBADENSIS LEAF EXTRACT, TOCOPHERYL ACETATE, ASCORBYL PALMITATE, RETINYL PALMITATE, LECITHIN, ALUMINUM STEARATE, TRIMETHYLSILOXYSILICATE, SORBITAN LAURATE, PROPYLENE GLYCOL LAURATE, PROPYLENE GLYCOL STEARATE, POLYSORBATE 20, STEARIC ACID [+/- TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499)] <ILN29118>

DIST. BY/PAR: MAKE-UP ART COSMETICS
TORONTO, ONTARIO, CANADA M5V 1R7, LONDON W1K 3BQ.

PRINCIPAL DISPLAY PANEL - 9 g Tube Carton

M•A•C

STUDIO STICK FOUNDATION SPF 15

NET WT./POIDS NET 9 g/.31 US OZ e

PRINCIPAL DISPLAY PANEL - 9 g Tube Carton
STUDIO FOUNDATION SPF 15 
octinoxate and titanium dioxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40046-0057
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.9 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
PROPYLENE GLYCOL MONOLAURATE (UNII: 668Z5835Z3)  
PROPYLENE GLYCOL STEARATE (UNII: MZM1I680W0)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:40046-0057-11 in 1 CARTON
19 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35208/06/2003
Labeler - MAKEUP ART COSMETICS (010597206)
Establishment
NameAddressID/FEIBusiness Operations
ELGC K.K.712808195RELABEL(40046-0057) , REPACK(40046-0057)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(40046-0057) , RELABEL(40046-0057) , REPACK(40046-0057)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Inc.042918826MANUFACTURE(40046-0057)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK(40046-0057) , RELABEL(40046-0057)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE(40046-0057)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(40046-0057)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(40046-0057)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326MANUFACTURE(40046-0057)
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(40046-0057)
Establishment
NameAddressID/FEIBusiness Operations
NORTEC KEYSTONE943871157MANUFACTURE(40046-0057) , RELABEL(40046-0057) , REPACK(40046-0057)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC BRISTOL959338336MANUFACTURE(40046-0057) , RELABEL(40046-0057) , REPACK(40046-0057)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC KEYSTONE949264774MANUFACTURE(40046-0057) , RELABEL(40046-0057) , REPACK(40046-0057)
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(40046-0057)
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058MANUFACTURE(40046-0057)
Establishment
NameAddressID/FEIBusiness Operations
Pennsylvania Logistics Center078364654REPACK(40046-0057) , RELABEL(40046-0057)
Establishment
NameAddressID/FEIBusiness Operations
PRIVATE LABEL SELECT LTD005415463MANUFACTURE(40046-0057)

Revised: 8/2012
Document Id: 6ac61092-2d20-45fd-a03b-e3be163388b1
Set id: ce99fd56-33cc-4ef7-bfe5-8a057d884229
Version: 1
Effective Time: 20120816
 
MAKEUP ART COSMETICS