CLINIQUE  SUPERDEFENSE AGE DEFENSE MOISTURIZER BROAD SPECTRUM SPF 25- avobenzone, octisalate, octocrylene, and oxybenzone 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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CLINIQUE SUPERDEFENSE AGE DEFENSE MOISTURIZER BROAD SPECTRUM SPF 25 COMBINATION OILY TO OILY

Drug Facts

Active ingredients

Avobenzone 3.0%
Octisalate 5.0%
Octocrylene 1.3%
Oxybenzone 5.0%

Purpose

Sunscreen

Use

helps prevent sunburn

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

Inactive ingredients

water • dimethicone • butylene glycol • butyloctyl salicylate • isononyl isononanoate • polyester-8 • silica • glycerin • polysilicone-11 • triticum vulgare (wheat bran) extract • algae extract • laminaria saccharina extract • olea europaea (olive) fruit extract • coffea robusta seed extract • echinacea pallida (coneflower) extract • rosmarinus officinalis (rosemary) extract • sea whip extract • astrocaryum murumuru seed butter • adenosine phosphate • trehalose • disodium nadh • padina pavonica (thallus) extract • creatine • sodium rna • caffeine • micrococcus lysate • nordihydroguaiaretic acid • sodium dna • phytosphingosine • linoleic acid • cholesterol • ascorbyl tocopheryl maleate • sodium hyaluronate • aminopropyl ascorbyl phosphate • tocopheryl acetate • trisiloxane • sucrose • laurdimonium hydroxypropyl hydrolyzed soy protein • lecithin • hexylene glycol • ethylhexyl stearate • ethylhexyl palmitate • decarboxy carnosine hcl • propylene glycol dicaprate • chamomilla recutita (matricaria) • zeolite • caprylyl glycol • polyethylene • xanthan gum • laureth-4 • laureth-23 • polysorbate 20 • ammonium acryloyldimethyltaurate/vp copolymer • acrylic acid/vp crosspolymer • arginine ferulate • tromethamine • disodium edta • phenoxyethanol [iln37043]

Other information

protect the product in this container from excessive heat and direct sun

© CLINIQUE LABORATORIES, DIST. NEW YORK, N.Y. 10022

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

CLINIQUE

superdefense

age defense moisturizer
broad spectrum SPF 25

COMBINATION OILY TO OILY

POIDS NET WT. 1.7 OZ./50 ml e

Principal Display Panel - 50 ml Jar Carton
CLINIQUE   SUPERDEFENSE AGE DEFENSE MOISTURIZER BROAD SPECTRUM SPF 25
avobenzone, octisalate, octocrylene, and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-709
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mL  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.3 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GLYCERIN (UNII: PDC6A3C0OX)  
WHEAT BRAN (UNII: 6L966A1IMR)  
saccharina latissima thallus (UNII: 68CMP2MB55)  
BLACK OLIVE (UNII: 2M6QWV94OC)  
ROBUSTA COFFEE BEAN (UNII: V5032728L7)  
ECHINACEA PALLIDA (UNII: 904CK3270L)  
ROSEMARY (UNII: IJ67X351P9)  
PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)  
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
ADENOSINE PHOSPHATE (UNII: 415SHH325A)  
TREHALOSE (UNII: B8WCK70T7I)  
PADINA PAVONICA (UNII: 177U06NHZI)  
CREATINE (UNII: MU72812GK0)  
CAFFEINE (UNII: 3G6A5W338E)  
MASOPROCOL (UNII: 7BO8G1BYQU)  
LINOLEIC ACID (UNII: 9KJL21T0QJ)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
AMINOPROPYL ASCORBYL PHOSPHATE (UNII: 290O2PQ83R)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TRISILOXANE (UNII: 9G1ZW13R0G)  
SUCROSE (UNII: C151H8M554)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY)  
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
XANTHAN GUM (UNII: TTV12P4NEE)  
LAURETH-4 (UNII: 6HQ855798J)  
LAURETH-23 (UNII: N72LMW566G)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
TROMETHAMINE (UNII: 023C2WHX2V)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49527-709-011 in 1 CARTON
150 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35204/01/2004
Labeler - CLINIQUE LABORATORIES INC (173047747)
Establishment
NameAddressID/FEIBusiness Operations
ELGC Kabushiki Kaisha712808195RELABEL(49527-709) , REPACK(49527-709)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(49527-709) , RELABEL(49527-709) , REPACK(49527-709)
Establishment
NameAddressID/FEIBusiness Operations
ARAMIS, INC042918826MANUFACTURE(49527-709)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK(49527-709) , RELABEL(49527-709)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE(49527-709)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD255175580MANUFACTURE(49527-709)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(49527-709)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326MANUFACTURE(49527-709)
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(49527-709)
Establishment
NameAddressID/FEIBusiness Operations
NORTEC KEYSTONE787336577MANUFACTURE(49527-709) , RELABEL(49527-709) , REPACK(49527-709)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC BRISTOL949264774MANUFACTURE(49527-709) , RELABEL(49527-709) , REPACK(49527-709)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC KEYSTONE618107429MANUFACTURE(49527-709) , RELABEL(49527-709) , REPACK(49527-709)
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(49527-709)
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058MANUFACTURE(49527-709)

Revised: 3/2012
Document Id: 1699bc81-2bf7-4cdb-a19e-708dfa2f32d3
Set id: 2b67a454-26ba-4049-854c-9335668236cd
Version: 1
Effective Time: 20120305
 
CLINIQUE LABORATORIES INC