EQUALIZER  SMART MAKEUP SPF 10- titanium dioxide lotion 
Estee Lauder Inc.

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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Equalizer
Smart Makeup

ACTIVE INGREDIENT

TITANIUM DIOXIDE 2.00%

INGREDIENTS

CYCLOPENTASILOXANE • WATER • BUTYLENE GLYCOL • POLYMETHYL METHACRYLATE • DIMETHICONE • ISOTETRACOSANE • HEXYLENE GLYCOL • PEG/PPG-18/18 DIMETHICONE • OCTYLDODECYL STEAROYL STEARATE • HYDROLYZED SOY PROTEIN • ISOSTEARYL NEOPENTANOATE • CHAMOMILLA RECUTITA (MATRICARIA) EXTRACT • LECITHIN • COCONUT ACID • DISTEARDIMONIUM HECTORITE • C9-15 FLUOROALCOHOL PHOSPHATE • POLYETHYLENE • LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER • POLYGLYCERYL-4 ISOSTEARATE • HEXYL LAURATE • CETYL PEG/PPG-10/1 DIMETHICONE • TOCOPHERYL LINOLEATE/OLEATE • SILICA • SODIUM CHLORIDE • LAURETH-7 • PROPYLENE CARBONATE • ALUMINA • DISODIUM EDTA • PHENOXYETHANOL • [+/- MICA • IRON OXIDES (CI 77491, CI 77492, CI 77499) • TITANIUM DIOXIDE (CI 77891) • CHROMIUM HYDROXIDE GREEN (CI 77289) • CHROMIUM OXIDE GREENS (CI 77288)]

WARNING

Keep out of eyes.

Stop use if irritation occurs.

Keep out of reach of children.

PRINCIPAL DISPLAY PANEL - 30 ml Carton

ESTĒE LAUDER

Equalizer
Smart Makeup

SPF 10

1 FL. OZ. LIQ./30ml e

Principal Display Panel - 30 ml Carton
EQUALIZER   SMART MAKEUP SPF 10
titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11559-736
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)  
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)  
COCONUT ACID (UNII: 40U37V505D)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
LAURETH-7 (UNII: Z95S6G8201)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11559-736-011 in 1 CARTON
130 mL in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35212/26/2008
Labeler - Estee Lauder Inc. (005914387)
Establishment
NameAddressID/FEIBusiness Operations
ELGC Kabushiki Kaisha712808195RELABEL, REPACK
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE, RELABEL, REPACK
Establishment
NameAddressID/FEIBusiness Operations
ARAMIS, INC042918826MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK, RELABEL
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD255175580MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
NORTEC KEYSTONE787336577MANUFACTURE, RELABEL, REPACK
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC BRISTOL949264774MANUFACTURE, RELABEL, REPACK
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC KEYSTONE618107429MANUFACTURE, RELABEL, REPACK
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058MANUFACTURE

Revised: 10/2011
Document Id: 57bb13de-f970-4ea2-aa61-d31b15527599
Set id: cc9ce7a1-86f9-47d5-98b1-34395285fc9a
Version: 1
Effective Time: 20111028
 
Estee Lauder Inc.