SPF 50  WITH SOLAR SMART- oxybenzone, octisalate, homosalate, 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
50
face cream

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

OXYBENZONE 5.0%, OCTISALATE 5.0%, HOMOSALATE 5.0%, AVOBENZONE 3.0%, OCTOCRYLENE 2.7%.

INGREDIENTS

WATER • METHYL TRIMETHICONE • BUTYLENE GLYCOL • BUTYLOCTYL SALICYLATE • NEOPENTYL GLYCOL DIHEPTANOATE • BUTYROSPERMUM PARKII (SHEA BUTTER) • PEG-100 STEARATE • SILICA • DI-PENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE • LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE • DIMETHICONE • GLYCERYL STEARATE • LAURDIMONIUM HYDROXYPROPYL HYDROLYZED SOY PROTEIN • ROSMARINUS OFFICINALIS (ROSEMARY) EXTRACT • PERILLA OCYMOIDES LEAF EXTRACT • PLANKTON EXTRACT • CAFFEINE • POTASSIUM CETYL PHOSPHATE • SUCROSE • STYRENE/ACRYLATES COPOLYMER • C30-38 OLEFIN/ISOPROPYL MALEATE/MA COPOLYMER • CETYL ALCOHOL • VP/EICOSENE COPOLYMER • ETHYLHEXYLGLYCERIN • AMMONIUM ACRYLOYLDIMETHYL TAURATE/VP COPOLYMER • PEG-8 LAURATE • SODIUM RNA • LECITHIN • PROPYL GALLATE • ARGININE FERULATE • TOCOPHERYL ACETATE • CAPRYLYL GLYCOL • ASCORBYL TOCOPHERYL MALEATE • STEARIC ACID • XANTHAN GUM • HEXYLENE GLYCOL • NORDIHYDROGUAIARETIC ACID • DISODIUM EDTA • PHENOXYETHANOL • MICA • SODIUM DEHYDROACETATE [ILN37123]

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

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton

CLINIQUE
SPF
50
with
SolarSmart

UVA UVB
advanced
protection

face cream

1.7 FL.OZ.
50 ml e

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton
SPF 50   WITH SOLAR SMART
oxybenzone, octisalate, homosalate, avobenzone, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-717
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
oxybenzone (UNII: 95OOS7VE0Y) (oxybenzone - UNII:95OOS7VE0Y) oxybenzone5 mL  in 100 mL
octisalate (UNII: 4X49Y0596W) (octisalate - UNII:4X49Y0596W) octisalate5 mL  in 100 mL
homosalate (UNII: V06SV4M95S) (homosalate - UNII:V06SV4M95S) homosalate5 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)  
methyl trimethicone (UNII: S73ZQI0GXM)  
butylene glycol (UNII: 3XUS85K0RA)  
butyloctyl salicylate (UNII: 2EH13UN8D3)  
neopentyl glycol diheptanoate (UNII: 5LKW3C543X)  
shea butter (UNII: K49155WL9Y)  
peg-100 stearate (UNII: YD01N1999R)  
silicon dioxide (UNII: ETJ7Z6XBU4)  
dimethicone (UNII: 92RU3N3Y1O)  
glyceryl monostearate (UNII: 230OU9XXE4)  
rosemary (UNII: IJ67X351P9)  
perilla frutescens leaf (UNII: T4L5881Y68)  
caffeine (UNII: 3G6A5W338E)  
potassium cetyl phosphate (UNII: 03KCY6P7UT)  
sucrose (UNII: C151H8M554)  
cetyl alcohol (UNII: 936JST6JCN)  
ethylhexylglycerin (UNII: 147D247K3P)  
peg-8 laurate (UNII: 762O8IWA10)  
propyl gallate (UNII: 8D4SNN7V92)  
alpha-tocopherol acetate (UNII: 9E8X80D2L0)  
caprylyl glycol (UNII: 00YIU5438U)  
stearic acid (UNII: 4ELV7Z65AP)  
xanthan gum (UNII: TTV12P4NEE)  
hexylene glycol (UNII: KEH0A3F75J)  
masoprocol (UNII: 7BO8G1BYQU)  
edetate disodium (UNII: 7FLD91C86K)  
phenoxyethanol (UNII: HIE492ZZ3T)  
mica (UNII: V8A1AW0880)  
sodium dehydroacetate (UNII: 8W46YN971G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49527-717-011 in 1 CARTON
150 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/01/2009
Labeler - CLINIQUE LABORATORIES INC. (173047747)
Establishment
NameAddressID/FEIBusiness Operations
ELGC Kabushiki Kaisha712808195RELABEL, REPACK
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE, RELABEL, REPACK
Establishment
NameAddressID/FEIBusiness Operations
ARAMIS, INC042918826MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK, RELABEL
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD255175580MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
NORTEC KEYSTONE787336577MANUFACTURE, RELABEL, REPACK
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC BRISTOL949264774MANUFACTURE, RELABEL, REPACK
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC KEYSTONE618107429MANUFACTURE, RELABEL, REPACK
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058MANUFACTURE

Revised: 10/2011
Document Id: ed67f891-45eb-4ce2-a39e-91d71ec741a8
Set id: e0f986c0-2be3-47ae-aef8-a8a3f14e9cee
Version: 1
Effective Time: 20111012
 
CLINIQUE LABORATORIES INC.