CLINIQUE  SKIN SUPPLIES FOR MEN AGE DEFENSE HYDRATOR BROAD SPECTRUM SPF 15- avobenzone, octinoxate, and octisalate liquid 
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
SKIN SUPPLIES FOR MEN AGE DEFENSE HYDRATOR BROAD SPECTRUM SPF 15

Drug Facts

Active ingredients

Avobenzone 2.0%
Octinoxate 7.5%
Octisalate 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 • octyldodecyl neopentanoate • hdi/trimethylol hexyllactone crosspolymer • neopentyl glycol diheptanoate • dimethicone • silica • steareth-21 • butylene glycol • pentylene glycol • sigesbeckia orientalis (st. paul's wort) extract • rosmarinus officinalis (rosemary) extract • polyethylene • coffea robusta seed extract • polygonum cuspidatum root extract • laurdimonium hydroxypropyl hydrolyzed soy protein • saccharomyces lysate extract • steareth-2 • astrocaryum murumuru seed butter • glycerin • hydrogenated lecithin • ethylhexyl stearate • polysilicone-11 • sucrose • pvp/hexadecene copolymer • acetyl glucosamine • isohexadecane • ethylhexylglycerin • caffeine • trimethylsiloxysilicate • glyceryl polymethacrylate • acrylates/c10-30 alkyl acrylate crosspolymer • linoleic acid • cholesterol • polysorbate 80 • palmitoyl oligopeptide • ethylhexyl palmitate • tromethamine • tetrahexyldecyl ascorbate • adenosine phosphate • peg-8 • lecithin • sodium dna • arginine ferulate • acetyl hexapeptide-8 • sodium hyaluronate • phytantriol • caprylyl glycol • xanthan gum • ascorbyl tocopheryl maleate • phytosphingosine • propylene glycol dicaprate • acrylamide/sodium acryloyldimethyltaurate copolymer • hexylene glycol • nordihydroguaiaretic acid • potassium sulfate • sodium carbomer • disodium edta • sorbic acid • chlorphenesin • potassium sorbate • phenoxyethanol [iln34202]

Other information

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

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton

CLINIQUE
skin supplies
for men

age defense hydrator
broad spectrum
SPF 15

hydrates, repairs, protects

ALL SKIN TYPES

1.7 FL.OZ.LIQ./50 ml e

Principal Display Panel - 50 ml Bottle Carton
CLINIQUE   SKIN SUPPLIES FOR MEN AGE DEFENSE HYDRATOR BROAD SPECTRUM SPF 15
avobenzone, octinoxate, and octisalate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-035
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.0203 g  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.076 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.0507 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
octyldodecyl neopentanoate (UNII: X8725R883T)  
neopentyl glycol diheptanoate (UNII: 5LKW3C543X)  
dimethicone (UNII: 92RU3N3Y1O)  
silicon dioxide (UNII: ETJ7Z6XBU4)  
steareth-21 (UNII: 53J3F32P58)  
butylene glycol (UNII: 3XUS85K0RA)  
pentylene glycol (UNII: 50C1307PZG)  
rosemary (UNII: IJ67X351P9)  
high density polyethylene (UNII: UG00KM4WR7)  
robusta coffee bean (UNII: V5032728L7)  
polygonum cuspidatum root (UNII: 7TRV45YZF7)  
saccharomyces lysate (UNII: R85W246Z1C)  
steareth-2 (UNII: V56DFE46J5)  
astrocaryum murumuru seed butter (UNII: 12V64UPU6R)  
glycerin (UNII: PDC6A3C0OX)  
ethylhexyl stearate (UNII: EG3PA2K3K5)  
sucrose (UNII: C151H8M554)  
n-acetylglucosamine (UNII: V956696549)  
isohexadecane (UNII: 918X1OUF1E)  
ethylhexylglycerin (UNII: 147D247K3P)  
caffeine (UNII: 3G6A5W338E)  
linoleic acid (UNII: 9KJL21T0QJ)  
cholesterol (UNII: 97C5T2UQ7J)  
polysorbate 80 (UNII: 6OZP39ZG8H)  
palmitoyl oligopeptide (UNII: HO4ZT5S86C)  
ethylhexyl palmitate (UNII: 2865993309)  
tromethamine (UNII: 023C2WHX2V)  
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)  
adenosine phosphate (UNII: 415SHH325A)  
polyethylene glycol 400 (UNII: B697894SGQ)  
acetyl hexapeptide-8 (UNII: L4EL31FWIL)  
hyaluronate sodium (UNII: YSE9PPT4TH)  
phytantriol (UNII: 8LVI07A72W)  
caprylyl glycol (UNII: 00YIU5438U)  
xanthan gum (UNII: TTV12P4NEE)  
ascorbyl tocopheryl maleate (UNII: D2G6259XR5)  
phytosphingosine (UNII: GIN46U9Q2Q)  
propylene glycol dicaprate (UNII: U783H9JHWY)  
hexylene glycol (UNII: KEH0A3F75J)  
masoprocol (UNII: 7BO8G1BYQU)  
potassium sulfate (UNII: 1K573LC5TV)  
edetate disodium (UNII: 7FLD91C86K)  
sorbic acid (UNII: X045WJ989B)  
chlorphenesin (UNII: I670DAL4SZ)  
potassium sorbate (UNII: 1VPU26JZZ4)  
phenoxyethanol (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49527-035-011 in 1 CARTON
150 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35207/14/2010
Labeler - CLINIQUE LABORATORIES INC. (173047747)
Establishment
NameAddressID/FEIBusiness Operations
ELGC K.K.712808195RELABEL(49527-035) , REPACK(49527-035)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(49527-035) , RELABEL(49527-035) , REPACK(49527-035)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK(49527-035) , RELABEL(49527-035)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(49527-035)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(49527-035)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326MANUFACTURE(49527-035)
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(49527-035)
Establishment
NameAddressID/FEIBusiness Operations
NORTEC KEYSTONE943871157MANUFACTURE(49527-035) , RELABEL(49527-035) , REPACK(49527-035)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC BRISTOL959338336MANUFACTURE(49527-035) , RELABEL(49527-035) , REPACK(49527-035)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC KEYSTONE949264774MANUFACTURE(49527-035) , RELABEL(49527-035) , REPACK(49527-035)
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(49527-035)
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058MANUFACTURE(49527-035)
Establishment
NameAddressID/FEIBusiness Operations
Pennsylvania Logistics Center078364654REPACK(49527-035) , RELABEL(49527-035)

Revised: 6/2013
Document Id: f28af51c-2628-45c9-b1c4-68341157bd53
Set id: ff348f48-352b-4f4c-8260-f412ef884213
Version: 1
Effective Time: 20130605
 
CLINIQUE LABORATORIES INC.