MAC HYPER REAL SPF 15 FOUNDATION

Dosage form: liquid
Ingredients: OCTINOXATE 7mL in 100mL
Labeler: MAKEUP ART COSMETICS
NDC Code: 40046-0056

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.

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

MAC   HYPER REAL SPF 15 FOUNDATION
octinoxate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40046-0056
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 5 
BUTYLENE GLYCOL 
SILICON DIOXIDE 
DIMETHICONE 
PHENYL TRIMETHICONE 
MAGNESIUM SULFATE 
TITANIUM DIOXIDE 
.ALPHA.-TOCOPHEROL ACETATE 
VITAMIN A PALMITATE 
ASCORBYL PALMITATE 
TRIETHOXYCAPRYLYLSILANE 
POLYGLYCERYL-4 ISOSTEARATE 
HEXYL LAURATE 
LAURETH-7 
TRIETHYL CITRATE 
PHENOXYETHANOL 
METHYLPARABEN 
MICA 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
BISMUTH OXYCHLORIDE 
CHROMIC OXIDE 
Packaging
#Item CodePackage Description
1NDC:40046-0056-11 BOTTLE (BOTTLE) 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/FEIOperations
ELGC K.K.712808195RELABEL(40046-0056), REPACK(40046-0056)
Establishment
NameAddressID/FEIOperations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(40046-0056), RELABEL(40046-0056), REPACK(40046-0056)
Establishment
NameAddressID/FEIOperations
Estee Lauder Inc.042918826MANUFACTURE(40046-0056)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK(40046-0056), RELABEL(40046-0056)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE(40046-0056)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(40046-0056)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(40046-0056)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER N.V.370151326MANUFACTURE(40046-0056)
Establishment
NameAddressID/FEIOperations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(40046-0056)
Establishment
NameAddressID/FEIOperations
NORTEC KEYSTONE943871157MANUFACTURE(40046-0056), RELABEL(40046-0056), REPACK(40046-0056)
Establishment
NameAddressID/FEIOperations
NORTHTEC BRISTOL959338336MANUFACTURE(40046-0056), RELABEL(40046-0056), REPACK(40046-0056)
Establishment
NameAddressID/FEIOperations
NORTHTEC KEYSTONE949264774MANUFACTURE(40046-0056), RELABEL(40046-0056), REPACK(40046-0056)
Establishment
NameAddressID/FEIOperations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(40046-0056)
Establishment
NameAddressID/FEIOperations
Aveda Corporation071352058MANUFACTURE(40046-0056)
Establishment
NameAddressID/FEIOperations
Pennsylvania Logistics Center078364654REPACK(40046-0056), RELABEL(40046-0056)

Revised: 05/2012
 
MAKEUP ART COSMETICS

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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