REPAIRWEAR LIFT SPF 15 FIRMING DAY COMBO TO OILY SKIN- octinoxate, 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% [] titanium dioxide 1.40%

ingredients: water [] cetyl ethylhexanoate [] butylene glycol [] glyceryl stearate [] peg-100 stearate [] octyldodecyl neopentanoate [] hydrogenated lecithin [] pentylene glycol [] coleus barbatus extract [] prunus amygdalus dulcis (sweet almond) seed extract [] olea europaea (olive) fruit extract [] triticum vulgare (wheat bran) extract [] sigesbeckia orientalis extract [] cholesterol/potassium sulfate [] persea gratissima (avocado) oil [] cucumis melo (melon) fruit extract [] betula alba (birch) bark extract [] decarboxy carnosine hcl [] polygonum cuspidatum root extract [] coffea robusta seed extract [] saccharomyces lysate extract [] isomerized linoleic acid [] whey protein [] glycerin [] creatine [] algae extract [] thermus thermophillus ferment [] linoleic acid [] cholesterol [] adenosine phosphate [] sodium dna [] polyethylene [] caffeine [] glycine soja (soybean) sterols [] lecithin [] astrocaryum murumuru seed butter [] trehalose [] acetyl hexapeptide-8 [] sodium rna [] sorbitol [] aminopropyl ascorbyl phosphate [] propylene glycol dicaprylate [] ethylhexyl palmitate [] sodium hyaluronate [] silica [] ethylhexyl stearate [] behenyl alcohol [] caprylyl glycol [] phytosphingosine [] hexylene glycol [] propylene glycol dicaprate [] ethylhexylglycerin [] xanthan gum [] carbomer [] potassium carbomer [] aluminum stearate [] potassium stearate [] disodium edta [] sodium dehydroacetate [] 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 CREAM


OILY/COMB SKIN

NT WT 1.7 OZ./50 ML


clinique laboratories distr.

new york, ny 10022


folding carton

REPAIRWEAR  LIFT SPF 15 FIRMING DAY COMBO TO OILY SKIN
octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.4 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PROPYLENE GLYCOL MONOSTEARATE (UNII: F76354LMGR)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
POTASSIUM SULFATE (UNII: 1K573LC5TV)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
CUCUMBER JUICE (UNII: 61845009SP)  
POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7)  
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
CREATINE (UNII: MU72812GK0)  
ADENOSINE PHOSPHATE (UNII: 415SHH325A)  
CAFFEINE (UNII: 3G6A5W338E)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
TREHALOSE (UNII: B8WCK70T7I)  
SORBITOL (UNII: 506T60A25R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49527-009-011 in 1 CARTON
1NDC:49527-009-0250 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/01/2010
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: 3/2011
Document Id: c6e53627-bd4a-4f91-8fdc-594b686f07c8
Set id: f17adf17-1113-4bf1-a3e8-3513a4a3b792
Version: 2
Effective Time: 20110317
 
CLINIQUE LABORATORIES INC