SUPERDEFENSE AGE DEFENSE MOISTURIZER BROAD SPECTRUM SPF 25 VERY DRY TO DRY- octisalate, oxybenzone, and 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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SUPERDEFENSE AGE DEFENSE MOISTURIZER BROAD SPECTRUM SPF 25 VERY DRY TO DRY

Drug Facts

Active ingredients

Avobenzone 3.0%
Octisalate 5.0%
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\aqua\eau • 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 [iln36954]

Other information

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

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

C

CLINIQUE

superdefense

age defense moisturizer
broad spectrum SPF 25

VERY DRY TO DRY

POIDS NET WT. 1.7 OZ./50 ml e

Principal Display Panel - 50 ml Jar Carton
SUPERDEFENSE AGE DEFENSE MOISTURIZER BROAD SPECTRUM SPF 25 VERY DRY TO DRY 
octisalate, oxybenzone, and avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-034
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.0508 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0508 g  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.0305 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
dimethicone (UNII: 92RU3N3Y1O)  
petrolatum (UNII: 4T6H12BN9U)  
butylene glycol (UNII: 3XUS85K0RA)  
butyloctyl salicylate (UNII: 2EH13UN8D3)  
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)  
padina pavonica (UNII: 177U06NHZI)  
trehalose (UNII: B8WCK70T7I)  
creatine (UNII: MU72812GK0)  
caffeine (UNII: 3G6A5W338E)  
masoprocol (UNII: 7BO8G1BYQU)  
astrocaryum murumuru seed butter (UNII: 12V64UPU6R)  
phytosphingosine (UNII: GIN46U9Q2Q)  
linoleic acid (UNII: 9KJL21T0QJ)  
cholesterol (UNII: 97C5T2UQ7J)  
ascorbyl tocopheryl maleate (UNII: D2G6259XR5)  
hyaluronate sodium (UNII: YSE9PPT4TH)  
aminopropyl ascorbyl phosphate (UNII: 290O2PQ83R)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
adenosine phosphate (UNII: 415SHH325A)  
decarboxy carnosine Hydrochloride (UNII: 6X7K9I5QR7)  
ethylhexyl stearate (UNII: EG3PA2K3K5)  
caprylyl glycol (UNII: 00YIU5438U)  
isohexadecane (UNII: 918X1OUF1E)  
high density polyethylene (UNII: UG00KM4WR7)  
docosanol (UNII: 9G1OE216XY)  
xanthan gum (UNII: TTV12P4NEE)  
potassium sulfate (UNII: 1K573LC5TV)  
polysorbate 80 (UNII: 6OZP39ZG8H)  
steareth-21 (UNII: 53J3F32P58)  
sucrose (UNII: C151H8M554)  
ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG)  
tromethamine (UNII: 023C2WHX2V)  
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:49527-034-011 in 1 CARTON
150 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35206/01/2010
Labeler - CLINIQUE LABORATORIES INC. (173047747)
Establishment
NameAddressID/FEIBusiness Operations
ELGC K.K.712808195RELABEL(49527-034) , REPACK(49527-034)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(49527-034) , RELABEL(49527-034) , REPACK(49527-034)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK(49527-034) , RELABEL(49527-034)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(49527-034)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(49527-034)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326MANUFACTURE(49527-034)
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(49527-034)
Establishment
NameAddressID/FEIBusiness Operations
NORTEC KEYSTONE943871157MANUFACTURE(49527-034) , RELABEL(49527-034) , REPACK(49527-034)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC BRISTOL959338336MANUFACTURE(49527-034) , RELABEL(49527-034) , REPACK(49527-034)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC KEYSTONE949264774MANUFACTURE(49527-034) , RELABEL(49527-034) , REPACK(49527-034)
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(49527-034)
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058MANUFACTURE(49527-034)
Establishment
NameAddressID/FEIBusiness Operations
Pennsylvania Logistics Center078364654REPACK(49527-034) , RELABEL(49527-034)

Revised: 4/2013
Document Id: 0eaa9753-0cc1-4a16-9c93-4242086acbfe
Set id: 9f68c46b-accd-47bd-bc79-84b37f5e097d
Version: 1
Effective Time: 20130418
 
CLINIQUE LABORATORIES INC.