MINERALIZE SPF 15 FOUNDATION LOOSE- titanium dioxide powder 
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 INGREDIENT: TITANIUM DIOXIDE 7.0%

INACTIVE INGREDIENTS: MICA [] HORDEUM DISTICHON (BARLEY) EXTRACT\EXTRAIT D'ORGE A DEUX RANGS [] TRITICUM VULGARE (WHEAT) GERM OIL [] ASCORBYL PALMITATE [] TOCOPHERYL ACETATE [] SQUALANE [] METHICONE [] POTASSIUM SORBATE [] CHLORPHENESIN []  [+/- TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] BISMUTH OXYCHLORIDE (CI 77163) [] BLUE 1 (CI 42090) [] CARMINE (CI 75470) [] CHROMIUM HYDROXIDE GREEN (CI 77289) [] CHROMIUM OXIDE GREENS (CI 77288) [] FERRIC FERROCYANIDE (CI 77510) [] YELLOW 5 LAKE (CI 19140) [] ZINC OXIDE (CI 77947)

WARNING: KEEP OUT OF EYES. DISCONTINUE USE IF IRRITATION DEVELOPS. KEEP OUT OF REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL:


MAC

MINERALIZE

SPF 15 FOUNDATION

LOOSE



8.5  g/ 0.30 US oz



makeup art cosmetics distr.
toronto, CANADA M3J 2W3
FOLDING CARTON




MINERALIZE  SPF 15 FOUNDATION LOOSE
titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40046-0031
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
BARLEY BRAN (UNII: 2TXV6Z67KP)  
WHEAT GERM OIL (UNII: 14C97E680P)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SQUALANE (UNII: GW89575KF9)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
COCHINEAL (UNII: TZ8Z31B35M)  
CHROMIC OXIDE (UNII: X5Z09SU859)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:40046-0031-11 in 1 CARTON
1NDC:40046-0031-28.5 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/01/2007
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
Establishment
NameAddressID/FEIBusiness Operations
CRYSTAL CLAIRE COSMETICS205493484manufacture

Revised: 9/2011
Document Id: dd5fb00e-588e-4ebc-be2e-9a2444101961
Set id: 11e0c85e-a1ba-42c1-a615-95057311b104
Version: 1
Effective Time: 20110912
 
MAKEUP ART COSMETICS