REPAIRWEAR LASERFOCUS ALL SMOOTH MAKEUP SPF 15- titanium dioxide, octocrylene lotion 
CLINIQUE LABORATORIES 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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active ingredients: titanium dioxide 2.90% [] octocrylene 2.00%

inactive ingredients: water [] methyl trimethicone [] phenyl trimethicone [] dimethicone [] triethylhexanoin [] butylene glycol [] trimethylsiloxysilicate [] peg-10 dimethicone [] lauryl peg-9 polydimethylsiloxyethyl dimethicone [] glycerin [] alumina [] astrocaryum murumuru seed butter [] whey protein\lactis protein\protéine du petit-lait [] sigesbeckia orientalis (st. paul's wort) extract [] micrococcus lysate [] acetyl hexapeptide-8 [] sodium hyaluronate [] palmitoyl oligopeptide [] sodium myristoyl sarcosinate [] dimethicone/peg-10/15 crosspolymer [] sodium chloride [] tocopheryl acetate [] acetyl glucosamine [] glyceryl polymethacrylate [] methicone [] disteardimonium hectorite [] lecithin [] dimethicone crosspolymer-3 [] peg-8 [] laureth-7 [] dipropylene glycol [] disodium edta [] polyaminopropyl biguanide [] phenoxyethanol []  [+/- mica [] titanium dioxide (ci 77891) [] iron oxides (ci 77491, ci 77492, ci 77499) [] bismuth oxychloride (ci 77163)]

warning: keep out of eyes. stop use if irritation occurs. keep out of reach of children

principal display panel:


CLINIQUE

REPAIRWEAR

LASERFOCUS

ALL SMOOTH MAKEUP

SPF 15


1 FL OZ LIQ/30 ML



CLINIQUE LABORATORIES INC DIST
NEW YORK, NY 10022
FOLDING CARTON






REPAIRWEAR  LASERFOCUS ALL SMOOTH MAKEUP SPF 15
titanium dioxide, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.9 mL  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.0 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
WHEY (UNII: 8617Z5FMF6)  
ACETYL HEXAPEPTIDE-3 (UNII: L4EL31FWIL)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y)  
LAURETH-7 (UNII: Z95S6G8201)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49527-011-011 in 1 CARTON
1NDC:49527-011-0230 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/2011
Labeler - CLINIQUE LABORATORIES INC (173047747)
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: 5a4c19e1-4570-4b11-abad-36b19cd16c35
Set id: 20f0fe50-5492-4b1f-8f0e-cb3844f789d5
Version: 1
Effective Time: 20110623
 
CLINIQUE LABORATORIES INC