SMASH BOX STUDIO SKIN 15 HOUR WEAR HYDRATING FOUNDATION SPF10- titanium dioxide 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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ACTIVE INGREDIENT: TITANIUM DIOXIDE, 4.7%

INACTIVE INGREDIENTS: WATER [] CYCLOPENTASILOXANE [] TRIMETHYLSILOXYSILICATE [] BUTYLENE GLYCOL [] TRIMETHYL PENTAPHENYL TRISILOXANE [] SILICA [] PHENYL TRIMETHICONE [] MAGNESIUM SULFATE [] POLYGLYCERYL-3 DIISOSTEARATE [] TRIBEHENIN [] PEG-10 DIMETHICONE [] BIS-PEG/PPG-14/14 DIMETHICONE [] TOCOPHERYL ACETATE [] SODIUM HYALURONATE [] GLYCERIN [] ETHYLHEXYLGLYCERIN [] POLYGLYCERYL-4 ISOSTEARATE [] CETYL PEG/PPG-10/1 DIMETHICONE [] METHICONE [] TETRAMETHYL HEXAPHENYL TETRASILOXANE [] PHENYL METHICONE [] DIMETHICONE [] LAURETH-7 [] POLYMETHYLSILSESQUIOXANE [] HEXYL LAURATE [] DISTEARDIMONIUM HECTORITE [] CELLULOSE GUM [] PROPYLENE CARBONATE [] ALUMINA [] XANTHAN GUM [] DIMETHICONE SILYLATE [] SORBIC ACID [] PHENOXYETHANOL [] CHLORPHENESIN []  [+/- IRON OXIDES (CI 77491, CI 77492, CI 77499) [] TITANIUM DIOXIDE (CI 77891)]

DIRECTIONS: APPLY BEFORE SUN EXPOSURE.

WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS. IF IRRITATION PERSISTS, CONSULT A HEALTH PRACTITIONER. KEEP OUT OF REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL


SMASHBOX

STUDIO SKIN

15 HOUR WEAR FOUNDATION

SPF 10



NET WT. 1 FL OZ/30 ML


MAKEUP ART COSMETICS Dist.

Smashbox Beauty Cosmetics Inc,

Culver City, CA 90232

 FOLDING CARTON




SMASH BOX STUDIO SKIN  15 HOUR WEAR HYDRATING FOUNDATION SPF10
titanium dioxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40046-0044
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.7 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
GLYCERIN (UNII: PDC6A3C0OX)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
LAURETH-7 (UNII: Z95S6G8201)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SORBIC ACID (UNII: X045WJ989B)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:40046-0044-11 in 1 CARTON
1NDC:40046-0044-230 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2009
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

Revised: 6/2011
Document Id: a033dc14-b42a-4f9f-b9f9-e00c1d8cb49d
Set id: 407d3216-9e7f-455c-9742-6035f0543fd0
Version: 1
Effective Time: 20110624
 
MAKEUP ART COSMETICS