REPAIRWEAR LIFT SPF 15 FIRMING DAY DRY COMBO SKIN- octinoxate, octisalate, titanium dioxide cream 
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: octinoxate 7.50% [] octisalate 3.50% [] titanium dioxide 1.00%

inactive ingredients: water [] neopentyl glycol diheptanoate [] cetyl alcohol [] glycerin [] polyethylene [] di-c12-15 alkyl fumarate [] petrolatum [] hydrogenated lecithin [] butylene glycol [] pentylene glycol [] isocetyl alcohol [] hydrogenated polyisobutene [] octyldodecyl myristate [] pentaerythrityl tetraethylhexanoate [] hexyldecyl stearate [] behenyl alcohol [] potato starch modified [] prunus amygdalus dulcis (sweet almond) seed extract [] olea europaea (olive) fruit extract [] coleus barbatus extract [] cucumis melo (melon) fruit extract [] saccharomyces lysate extract [] triticum vulgare (wheat bran) extract [] coffea robusta seed extract [] whey protein\lactis protein\protéine du petit-lait [] betula alba (birch) bark extract [] algae extract [] octyldodecyl neopentanoate [] persea gratissima (avocado) oil [] sigesbeckia orientalis (st. paul's wort) extract [] polygonum cuspidatum root extract [] thermus thermophillus ferment [] isomerized linoleic acid [] dimethicone [] c12-16 alcohols [] linoleic acid [] peg-100 stearate [] caprylyl glycol [] caffeine [] palmitic acid [] glycine soja (soybean) sterols [] aluminum stearate [] glyceryl stearate [] trehalose [] sodium rna [] creatine [] hexylene glycol [] sorbitol [] polysilicone-11 [] adenosine phosphate [] aminopropyl ascorbyl phosphate [] propylene glycol dicaprylate [] cholesterol/potassium sulfate [] ethylhexyl palmitate [] sodium hyaluronate [] decarboxy carnosine hcl [] cholesterol [] sodium dna [] astrocaryum murumuru seed butter [] ethylhexyl stearate [] phytosphingosine [] propylene glycol dicaprate [] acetyl hexapeptide-8 [] xanthan gum [] sodium stearate [] sodium carbomer [] sodium citrate [] disodium edta [] potassium sorbate [] phenoxyethanol

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

principal display panel:


CLINIQUE

REPAIRWEAR LIFT SPF 15

FIRMING DAY CREAM

DRY COMBINATION SKIN


1.7  OZ/ 50 ML


CLINIQUE LABORATORIES DISTR.

NEW YORK, NY 10022

FOLDING CARTON



REPAIRWEAR LIFT  SPF 15 FIRMING DAY DRY COMBO SKIN
octinoxate, octisalate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-719
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3.5 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.0 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
DI-C12-15 ALKYL FUMARATE (UNII: A1CB3Z898P)  
PETROLATUM (UNII: 4T6H12BN9U)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
ISOCETYL ALCOHOL (UNII: 1800H64066)  
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
OCTYLDODECYL MYRISTATE (UNII: S013N99GR8)  
DOCOSANOL (UNII: 9G1OE216XY)  
STARCH, POTATO (UNII: 8I089SAH3T)  
ALMOND (UNII: 3Z252A2K9G)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
PLECTRANTHUS BARBATUS ROOT (UNII: V5741391RG)  
CUCUMBER (UNII: YY7C30VXJT)  
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
WHEAT GERM (UNII: YR3G369F5A)  
ROBUSTA COFFEE BEAN (UNII: V5032728L7)  
WHEY (UNII: 8617Z5FMF6)  
BETULA PUBESCENS BARK (UNII: 3R504894L9)  
SEAWEED (UNII: 477TV3P5UX)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7)  
LINOLEIC ACID (UNII: 9KJL21T0QJ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
C12-16 ALCOHOLS (UNII: S4827SZE3L)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CAFFEINE (UNII: 3G6A5W338E)  
PALMITIC ACID (UNII: 2V16EO95H1)  
ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
TREHALOSE (UNII: B8WCK70T7I)  
CREATINE (UNII: MU72812GK0)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
SORBITOL (UNII: 506T60A25R)  
ADENOSINE PHOSPHATE (UNII: 415SHH325A)  
PROPYLENE GLYCOL DICAPRYLATE (UNII: 581437HWX2)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY)  
ACETYL HEXAPEPTIDE-3 (UNII: L4EL31FWIL)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM STEARATE (UNII: QU7E2XA9TG)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49527-719-011 in 1 CARTON
1NDC:49527-719-0250 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/01/2007
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: 7/2011
Document Id: f887bd06-097b-4391-b4e4-68c1ce76cdd6
Set id: 7e2068be-38f3-4bd9-ac08-3f572f6db2e8
Version: 1
Effective Time: 20110725
 
CLINIQUE LABORATORIES INC