SUPER DEFENSE SUPERDEFENSE AGE DEFENSE MOISTURIZER SPF 25 DRY COMBINATION

Dosage form: cream
Ingredients: OXYBENZONE 5.0mL in 100mL, OCTISALATE 5.0mL in 100mL, AVOBENZONE 3.0mL in 100mL
Labeler: CLINIQUE LABORATORIES INC
NDC Code: 49527-707

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.

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



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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBENZONE (OXYBENZONE) OXYBENZONE5.0 mL  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE5.0 mL  in 100 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE3.0 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
DIMETHICONE 
PETROLATUM 
BUTYLENE GLYCOL 
BUTYLOCTYL SALICYLATE 
POLYGLYCERYL-4 ISOSTEARATE 
MEDIUM-CHAIN TRIGLYCERIDES 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
ROBUSTA COFFEE BEAN 
ECHINACEA PALLIDA 
ROSEMARY 
PSEUDOPTEROGORGIA ELISABETHAE 
SACCHAROMYCES LYSATE 
TREHALOSE 
CREATINE 
CAFFEINE 
MASOPROCOL 
ASTROCARYUM MURUMURU SEED BUTTER 
LINOLEIC ACID 
CHOLESTEROL 
LAMINARIA DIGITATA 
HYALURONATE SODIUM 
ALPHA-TOCOPHEROL ACETATE 
ADENOSINE PHOSPHATE DISODIUM 
MATRICARIA RECUTITA 
ETHYLHEXYL STEARATE 
CAPRYLYL GLYCOL 
ISOHEXADECANE 
LECITHIN, SOYBEAN 
DOCOSANOL 
XANTHAN GUM 
POTASSIUM SULFATE 
POLYSORBATE 80 
STEARETH-21 
SUCROSE 
TROMETHAMINE 
CARBOMER HOMOPOLYMER TYPE C 
GLYCERIN 
ETHYLHEXYL PALMITATE 
PROPYLENE GLYCOL DICAPRATE 
HEXYLENE GLYCOL 
EDETATE DISODIUM 
PHENOXYETHANOL 
CETEARYL GLUCOSIDE 
LAUROYL LYSINE 
HYDROGENATED SOYBEAN LECITHIN 
Packaging
#Item CodePackage Description
1NDC:49527-707-011 JAR (JAR) 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/FEIOperations
ESTEE LAUDER COSMETICS, LTD205952385manufacture
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER N.V.370151326manufacture
Establishment
NameAddressID/FEIOperations
Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
Establishment
NameAddressID/FEIOperations
Aramis Inc.042918826manufacture
Establishment
NameAddressID/FEIOperations
Northtec Bristol949264774manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Northtec Keystone618107429manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics, Ltd.255175580manufacture
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics, Ltd253616536manufacture
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics Distribution Center208579636repack, relabel
Establishment
NameAddressID/FEIOperations
Estee Lauder Kabushiki Kaisha712808195relabel, repack
Establishment
NameAddressID/FEIOperations
Whitman Laboratories Ltd.216866277manufacture
Establishment
NameAddressID/FEIOperations
Aveda Corporation071352058manufacture

Revised: 06/2011
 
CLINIQUE LABORATORIES INC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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