CLINIQUE  SPF 15 WITH SOLAR SMART ADVANCED PROTECTION- homosalate, octisalate, avobenzone, and octocrylene 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
SPF
15
with
SolarSmart

TO USE

Apply liberally before sun exposure and as needed. Children under 6 months of age: ask a doctor. Reapply frequently, and after towel drying, swimming or perspiring.

WARNING

For external use only. Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash or irritation develops and lasts.

Keep out of reach of children. If swallowed, get medical help right away.

ACTIVE INGREDIENTS

HOMOSALATE 10.0% • OCTISALATE 5.0% • AVOBENZONE 3.0% • OCTOCRYLENE 2.7%

INGREDIENTS

WATER • BUTYLENE GLYCOL • ISONONYL ISONONANDATE • BUTYLOCTYL SALICYLATE • TRIACONTANYL PVP • POLYESTER-8 • SILICA • ROSMARINUS OFFICINALIS (ROSEMARY) EXTRACT • PERILLA OCYMOIDES LEAF EXTRACT • STEARYL DIMETHICONE • CAFFEINE • PLANKTON EXTRACT • SUCROSE • HYDROGENATED LECITHIN • POTASSIUM CETYL PHOSPHATE • LAURDIMONIUM HYDROXYPROPYL HYDROLYZED SOY PROTEIN • PEG-100 STEARATE • CETYL ALCOHOL • POLYETHYLENE • ACRYLIC ACID/VP CROSSPOLYMER • VP/EICOSENE COPOLYMER • TOCOPHERYL ACETATE • TROMETHAMINE • SODIUM RNA • ALOE BARBADENSIS POWDER • PHOSPHOLIPIDS • LECITHIN • MAGNESIUM ASCORBYL PHOSPHATE • SODIUM HYALURONATE • HYDROXYPROPYL METHYLCELLULOSE • C1-8 ALKYL TETRAHYDROXYCYCLOHEXANOATE • HYDROXYETHYLCELLULOSE • ASCORBYL TOCOPHERYL MALEATE • MALTODEXTRIN • CAPRYLYL GLYCOL • HEXYLENE GLYCOL • NORDIHYDROGUAIARETIC ACID • FERULIC ACID • DISODIUM EDTA • PHENOXYETHANOL • CHLORPHENESIN • MICA [ILN34995]

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

PRINCIPAL DISPLAY PANEL - 150 ml Carton

CLINIQUE

SPF
15
with SolarSmart

UVA UVB
advanced
protection

face/body
cream

5 FL. OZ.
150 ml e

Principal Display Panel - 150 ml Carton
CLINIQUE   SPF 15 WITH SOLAR SMART ADVANCED PROTECTION
homosalate, octisalate, avobenzone, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-735
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
homosalate (UNII: V06SV4M95S) (homosalate - UNII:V06SV4M95S) homosalate10 mL  in 100 mL
octisalate (UNII: 4X49Y0596W) (octisalate - UNII:4X49Y0596W) octisalate5 mL  in 100 mL
avobenzone (UNII: G63QQF2NOX) (avobenzone - UNII:G63QQF2NOX) avobenzone3 mL  in 100 mL
octocrylene (UNII: 5A68WGF6WM) (octocrylene - UNII:5A68WGF6WM) octocrylene2.7 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
butylene glycol (UNII: 3XUS85K0RA)  
isononyl isononanoate (UNII: S4V5BS6GCX)  
butyloctyl salicylate (UNII: 2EH13UN8D3)  
triacontanyl pvp (wp-660) (UNII: N0SS3Q238D)  
silicon dioxide (UNII: ETJ7Z6XBU4)  
rosemary (UNII: IJ67X351P9)  
perilla frutescens leaf (UNII: T4L5881Y68)  
caffeine (UNII: 3G6A5W338E)  
sucrose (UNII: C151H8M554)  
potassium cetyl phosphate (UNII: 03KCY6P7UT)  
peg-100 stearate (UNII: YD01N1999R)  
cetyl alcohol (UNII: 936JST6JCN)  
high density polyethylene (UNII: UG00KM4WR7)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
tromethamine (UNII: 023C2WHX2V)  
magnesium ascorbyl phosphate (UNII: 0R822556M5)  
hyaluronate sodium (UNII: YSE9PPT4TH)  
maltodextrin (UNII: 7CVR7L4A2D)  
caprylyl glycol (UNII: 00YIU5438U)  
hexylene glycol (UNII: KEH0A3F75J)  
masoprocol (UNII: 7BO8G1BYQU)  
ferulic acid (UNII: AVM951ZWST)  
edetate disodium (UNII: 7FLD91C86K)  
phenoxyethanol (UNII: HIE492ZZ3T)  
chlorphenesin (UNII: I670DAL4SZ)  
mica (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49527-735-011 in 1 CARTON
1150 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35203/01/2009
Labeler - CLINIQUE LABORATORIES INC. (173047747)
Establishment
NameAddressID/FEIBusiness Operations
ELGC K.K.712808195RELABEL(49527-735) , REPACK(49527-735)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(49527-735) , RELABEL(49527-735) , REPACK(49527-735)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Inc.042918826MANUFACTURE(49527-735)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK(49527-735) , RELABEL(49527-735)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE(49527-735)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(49527-735)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(49527-735)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326MANUFACTURE(49527-735)
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(49527-735)
Establishment
NameAddressID/FEIBusiness Operations
NORTEC KEYSTONE943871157MANUFACTURE(49527-735) , RELABEL(49527-735) , REPACK(49527-735)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC BRISTOL959338336MANUFACTURE(49527-735) , RELABEL(49527-735) , REPACK(49527-735)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC KEYSTONE949264774MANUFACTURE(49527-735) , RELABEL(49527-735) , REPACK(49527-735)
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(49527-735)
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058MANUFACTURE(49527-735)
Establishment
NameAddressID/FEIBusiness Operations
Pennsylvania Logistics Center078364654REPACK(49527-735) , RELABEL(49527-735)

Revised: 8/2012
Document Id: ccaf35c2-e800-4f09-9881-55decb422123
Set id: 340c82a5-bbf5-4528-bb25-51aa267f3b8a
Version: 1
Effective Time: 20120806
 
CLINIQUE LABORATORIES INC.