MAC SELECT TINT SPF 15

Dosage form: liquid
Ingredients: OCTINOXATE 7.5mL in 100mL
Labeler: MAKEUP ART COSMETICS
NDC Code: 40046-0055

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
SELECT TINT SPF 15

ACTIVE INGREDIENT

OCTINOXATE 7.50%

INGREDIENTS

WATER\AQUA\EAU, DIMETHICONE, SILICA, CETYL DIMETHICONE, PHENYL TRIMETHICONE, BUTYLENE GLYCOL, POLYDECENE, GLYCERYL DILAURATE, ISOSTEARIC ACID, TROMETHAMINE, TOCOPHERYL ACETATE, SODIUM HYALURONATE, SUCROSE, HYDROGENATED LECITHIN, CAFFEINE, LINOLEIC ACID, XANTHAN GUM, CELLULOSE GUM, CHOLESTEROL, POLYETHYLENE, MAGNESIUM ALUMINUM SILICATE, PEG-9 DIMETHICONE, ETHYLHEXYLGLYCERIN, CAPRYLYL GLYCOL, HEXYLENE GLYCOL, TETRADIBUTYL PENTAERITHRITYL HYDROXYHYDROCINNAMATE, STEARETH-21, STEARETH-2, STEARIC ACID, POLYPERFLUOROMETHYLISOPROPYL ETHER, TETRASODIUM EDTA, BENZOIC ACID, DEHYDROACETIC ACID, PHENOXYETHANOL [+/- MICA, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499), CHROMIUM OXIDE GREENS (CI 77288)] <ILN32363>

WARNING

KEEP OUT OF EYES.

STOP USE IF IRRITATION OCCURS.

KEEP OUT OF REACH OF CHILDREN.

DIST. BY/PAR: MAKE-UP ART COSMETICS
TORONTO, ONTARIO, CANADA M5V 1R7,
LONDON W1K 3BQ. / M3H2

PRINCIPAL DISPLAY PANEL - 50 ML Bottle Carton

M•A•C

SELECT TINT SPF 15

50 ML/1.7 US FL OZ e

MAC  SELECT TINT SPF 15
octinoxate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40046-0055
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
DIMETHICONE 
SILICON DIOXIDE 
PHENYL TRIMETHICONE 
BUTYLENE GLYCOL 
GLYCERYL DILAURATE 
ISOSTEARIC ACID 
TROMETHAMINE 
.ALPHA.-TOCOPHEROL ACETATE 
HYALURONATE SODIUM 
SUCROSE 
CAFFEINE 
LINOLEIC ACID 
XANTHAN GUM 
CARBOXYMETHYLCELLULOSE SODIUM 
CHOLESTEROL 
HIGH DENSITY POLYETHYLENE 
MAGNESIUM ALUMINUM SILICATE 
ETHYLHEXYLGLYCERIN 
CAPRYLYL GLYCOL 
HEXYLENE GLYCOL 
STEARETH-21 
STEARETH-2 
STEARIC ACID 
EDETATE SODIUM 
BENZOIC ACID 
DEHYDROACETIC ACID 
PHENOXYETHANOL 
MICA 
TITANIUM DIOXIDE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
CHROMIC OXIDE 
Packaging
#Item CodePackage Description
1NDC:40046-0055-11 BOTTLE (BOTTLE) in 1 CARTON
150 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35208/01/2002
Labeler - MAKEUP ART COSMETICS (010597206)
Establishment
NameAddressID/FEIOperations
ELGC K.K.712808195RELABEL(40046-0055), REPACK(40046-0055)
Establishment
NameAddressID/FEIOperations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(40046-0055), RELABEL(40046-0055), REPACK(40046-0055)
Establishment
NameAddressID/FEIOperations
Estee Lauder Inc.042918826MANUFACTURE(40046-0055)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636RELABEL(40046-0055), REPACK(40046-0055)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE(40046-0055)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(40046-0055)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(40046-0055)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER N.V.370151326MANUFACTURE(40046-0055)
Establishment
NameAddressID/FEIOperations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(40046-0055)
Establishment
NameAddressID/FEIOperations
NORTEC KEYSTONE943871157MANUFACTURE(40046-0055), RELABEL(40046-0055), REPACK(40046-0055)
Establishment
NameAddressID/FEIOperations
NORTHTEC BRISTOL959338336MANUFACTURE(40046-0055), RELABEL(40046-0055), REPACK(40046-0055)
Establishment
NameAddressID/FEIOperations
NORTHTEC KEYSTONE949264774MANUFACTURE(40046-0055), RELABEL(40046-0055), REPACK(40046-0055)
Establishment
NameAddressID/FEIOperations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(40046-0055)
Establishment
NameAddressID/FEIOperations
Aveda Corporation071352058MANUFACTURE(40046-0055)
Establishment
NameAddressID/FEIOperations
Pennsylvania Logistics Center078364654REPACK(40046-0055), RELABEL(40046-0055)

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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