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


inactive ingredients: water [] dimethicone [] petrolatum [] butylene glycol [] butyloctyl salicylate [] polyglyceryl-2 triisostearate [] caprylic/capric/myristic/stearic triglyceride [] polyester-8 [] glyceryl stearate [] peg-100 stearate [] coffea robusta seed extract [] echinacea pallida (coneflower) extract [] rosmarinus officinalis (rosemary) extract [] sea whip extract [] isopropyl ppg-2-isodeceth-7 carboxylate [] padina pavonica (thallus) extract [] micrococcus lysate [] disodium nadh [] trehalose [] creatine [] sodium rna [] caffeine [] nordihydroguaiaretic acid [] sodium dna [] astrocaryum murumuru seed butter [] phytosphingosine [] linoleic acid [] cholesterol [] ascorbyl tocopheryl maleate [] algae extract [] sodium hyaluronate [] aminopropyl ascorbyl phosphate [] tocopheryl acetate [] adenosine phosphate [] laurdimonium hydroxypropyl hydrolyzed soy protein [] chamomilla recutita (matricaria) [] decarboxy carnosine hcl [] ethylhexyl stearate [] caprylyl glycol [] isohexadecane [] polyethylene [] zeolite [] lecithin [] behenyl alcohol [] xanthan gum [] potassium sulfate [] polysorbate 80 [] steareth-21 [] acrylamide/sodium acryloyldimethyltaurate copolymer [] ammonium acryloyldimethyltaurate/vp copolymer [] sucrose [] tromethamine [] carbomer [] glycerin [] ethylhexyl palmitate [] arginine ferulate [] propylene glycol dicaprate [] hexylene glycol [] disodium edta [] phenoxyethanol

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

principal display panel:


CLINIQUE

SUPERDEFENSE

AGE DEFENSE MOISTURIZER

FOR VERY DRY TO DRY SKIN



1.7 OZ/ 50 ML


clinique laboratories distr

new york, ny 10022

FOLDING CARTON


SUPER DEFENSE  SUPERDEFENSE AGE DEFENSE MOISTURIZER SPF 25 VERY DRY SKIN
oxybenzone, octisalate, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-708
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49527-708-011 in 1 CARTON
1NDC:49527-708-0250 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: 169e5628-2a40-429c-9bf8-cf24ce3fb9eb
Set id: e5069e15-09c0-4eb1-8030-bbe65e5a4a76
Version: 1
Effective Time: 20110628
 
CLINIQUE LABORATORIES INC