MAC  HYPER REAL SPF 15 FOUNDATION- octinoxate liquid 
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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M•A•C
HYPER REAL SPF 15 FOUNDATION

WARNING

KEEP OUT OF EYES.

STOP USE IF IRRITATION OCCURS.

KEEP OUT OF REACH OF CHILDREN.

ACTIVE INGREDIENT

OCTINOXATE 7.00%

INGREDIENTS

WATER (AQUA PURIFICATA) PURIFIED, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, SILICA, DIMETHICONE, PHENYL TRIMETHICONE, BIS-PEG/PPG-14/14 DIMETHICONE, MAGNESIUM SULFATE, TRIMETHYLSILOXYSILICATE, TITANIUM DIOXIDE, TOCOPHERYL ACETATE, RETINYL PALMITATE, ASCORBYL PALMITATE, DISTEARDIMONIUM HECTORITE, TRIETHOXYCAPRYLYLSILANE, POLYGLYCERYL-4 ISOSTEARATE, HEXYL LAURATE, CETYL PEG/PPG-10/1 DIMETHICONE, LAURETH-7, TRIETHYL CITRATE, PHENOXYETHANOL, METHYLPARABEN [+/-(MAY CONTAIN): MICA, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499), BISMUTH OXYCHLORIDE (CI 77163), CHROMIUM OXIDE GREENS (CI 77288)] <ILN28730>

DIST. BY/PAR: MAKE-UP ART COSMETICS
TORONTO, ONTARIO, CANADA M5V 1R7,
LONDON W1K 3BQ. / M49W

PRINCIPAL DISPLAY PANEL - 30 ML Bottle Carton

M•A•C

HYPER REAL SPF 15
FOUNDATION

30 ML/1.0 US FL OZ e

PRINCIPAL DISPLAY PANEL - 30 ML Bottle Carton
MAC   HYPER REAL SPF 15 FOUNDATION
octinoxate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40046-0056
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
MAGNESIUM SULFATE (UNII: DE08037SAB)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
LAURETH-7 (UNII: Z95S6G8201)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
CHROMIC OXIDE (UNII: X5Z09SU859)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:40046-0056-11 in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35206/01/2003
Labeler - MAKEUP ART COSMETICS (010597206)
Establishment
NameAddressID/FEIBusiness Operations
ELGC K.K.712808195RELABEL(40046-0056) , REPACK(40046-0056)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(40046-0056) , RELABEL(40046-0056) , REPACK(40046-0056)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Inc.042918826MANUFACTURE(40046-0056)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK(40046-0056) , RELABEL(40046-0056)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE(40046-0056)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(40046-0056)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(40046-0056)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326MANUFACTURE(40046-0056)
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(40046-0056)
Establishment
NameAddressID/FEIBusiness Operations
NORTEC KEYSTONE943871157MANUFACTURE(40046-0056) , RELABEL(40046-0056) , REPACK(40046-0056)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC BRISTOL959338336MANUFACTURE(40046-0056) , RELABEL(40046-0056) , REPACK(40046-0056)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC KEYSTONE949264774MANUFACTURE(40046-0056) , RELABEL(40046-0056) , REPACK(40046-0056)
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(40046-0056)
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058MANUFACTURE(40046-0056)
Establishment
NameAddressID/FEIBusiness Operations
Pennsylvania Logistics Center078364654REPACK(40046-0056) , RELABEL(40046-0056)

Revised: 5/2012
Document Id: c536f599-2180-45b3-a767-bf3923768d77
Set id: 36e3b619-a9a3-4baf-8b01-248b357ed3eb
Version: 1
Effective Time: 20120502
 
MAKEUP ART COSMETICS