SUPER DEFENSE SUPERDEFENSE AGE DEFENSE MOISTURIZER SPF 25 DRY COMBINATION- oxybenzone, octisalate, avobenzone 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: octisalate 5.00% [] oxybenzone 5.00% [] avobenzone 3.00%

inactive ingredients: water\aqua\eau [] dimethicone [] butyloctyl salicylate [] polyester-8 [] butylene glycol [] cetearyl alcohol [] silica [] glyceryl stearate [] peg-100 stearate [] glycerin [] hydrogenated lecithin [] coffea robusta seed extract [] echinacea pallida (coneflower) extract [] rosmarinus officinalis (rosemary) extract [] padina pavonica (thallus) extract [] petrolatum [] isopropyl ppg-2-isodeceth-7 carboxylate [] sea whip extract [] jojoba esters [] adenosine phosphate [] disodium nadh [] trehalose [] creatine [] sodium rna [] caffeine [] nordihydroguaiaretic acid [] sodium dna [] phytosphingosine [] linoleic acid [] cholesterol [] ascorbyl tocopheryl maleate [] lauroyl lysine [] sodium hyaluronate [] aminopropyl ascorbyl phosphate [] tocopheryl acetate [] sucrose [] micrococcus lysate [] astrocaryum murumuru seed butter [] cetearyl glucoside [] laurdimonium hydroxypropyl hydrolyzed soy protein [] dimethiconol [] lecithin [] algae extract [] hexylene glycol [] ethylhexyl stearate [] ethylhexyl palmitate [] propylene glycol dicaprate [] chamomilla recutita (matricaria) [] caprylyl glycol [] isohexadecane [] polyethylene [] ethylhexylglycerin [] zeolite [] behenyl alcohol [] polysorbate 80 [] acrylamide/sodium acryloyldimethyltaurate copolymer [] acrylates/c10-30 alkyl acrylate crosspolymer [] tromethamine [] arginine ferulate [] decarboxy carnosine hcl [] xanthan gum [] sodium chloride [] potassium sulfate [] disodium edta [] phenoxyethanol

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

PRINCIPAL DISPLAY PANEL:



CLINIQUE

SUPERDEFENSE SPF

AGE DEFENSE MOISTURIZER

SPF 25

DRY COMBINATION SKIN



NT WT. 1.7 OZ./50 ML



CLINIQUE LABORATORIES INC, DISTR

NEW YORK, NY 10022

FOLDING CARTON



SUPER DEFENSE  SUPERDEFENSE AGE DEFENSE MOISTURIZER SPF 25 DRY COMBINATION
oxybenzone, octisalate, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-707
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5.0 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.0 mL  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3.0 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PETROLATUM (UNII: 4T6H12BN9U)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
ROBUSTA COFFEE BEAN (UNII: V5032728L7)  
ECHINACEA PALLIDA (UNII: 904CK3270L)  
ROSEMARY (UNII: IJ67X351P9)  
PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)  
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
TREHALOSE (UNII: B8WCK70T7I)  
CREATINE (UNII: MU72812GK0)  
CAFFEINE (UNII: 3G6A5W338E)  
MASOPROCOL (UNII: 7BO8G1BYQU)  
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
LINOLEIC ACID (UNII: 9KJL21T0QJ)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ADENOSINE PHOSPHATE DISODIUM (UNII: T1WZ11DSRN)  
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
DOCOSANOL (UNII: 9G1OE216XY)  
XANTHAN GUM (UNII: TTV12P4NEE)  
POTASSIUM SULFATE (UNII: 1K573LC5TV)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
STEARETH-21 (UNII: 53J3F32P58)  
SUCROSE (UNII: C151H8M554)  
TROMETHAMINE (UNII: 023C2WHX2V)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
GLYCERIN (UNII: PDC6A3C0OX)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
LAUROYL LYSINE (UNII: 113171Q70B)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49527-707-011 in 1 CARTON
1NDC:49527-707-0250 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/01/2008
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: df1d5fe1-1708-49e2-a9cd-5a473c822202
Set id: 02e18eef-3ef1-4f02-a031-c127d0836f31
Version: 1
Effective Time: 20110628
 
CLINIQUE LABORATORIES INC