CX DAILY EYE PROTECTOR SPF 15- titanium dioxide gel 
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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active ingredient: titanium dioxide 7.80%

inactive ingredients: cyclopentasiloxane [] dimethicone [] trioctyldodecyl citrate [] silica [] isododecane [] vinyl dimethicone/methicone silsesquioxane crosspolymer [] dimethicone/vinyl dimethicone crosspolymer [] trimethylsiloxysilicate [] polysilicone-11 [] aluminum stearate [] mimosa tenuiflora bark extract [] tocopheryl acetate [] vitis vinifera (grape) seed oil [] 7-dehydrocholesterol [] tricaprylin [] tetrahexyldecyl ascorbate [] butylene glycol [] water\aqua\eau [] tocotrienols [] aminopropyl ascorbyl phosphate [] stearic acid [] methicone [] phenoxyethanol [] mica [] iron oxides (ci 77491, ci 77492, ci 77499) [] titanium dioxide (ci 77891)

warning: keep out of eyes. stop use if irritation occurs. keep out of reach of children

PRINCIPAL DISPLAY PANEL FOR OTC SUNSCREEN PRODUCT INCLUDED IN SET. SET ALSO CONTAINS A COSMETIC PRODUCT:


CLINIQUE


CX

24 HOUR EYE DE-AGING SYSTEM

DAILY EYE PROTECTOR

SPF 15



CLINIQUE LABORATORIES, INC

NEW YORK, NY 10022

FOLDING CARTON

CX DAILY EYE PROTECTOR  SPF 15
titanium dioxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-750
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7.8 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TRICAPRYLYL CITRATE (UNII: BXW1GAI4TA)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ISODODECANE (UNII: A8289P68Y2)  
ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
MIMOSA TENUIFLORA BARK (UNII: 515MQE449I)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)  
TRICAPRYLIN (UNII: 6P92858988)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49527-750-011 in 1 CARTON
1NDC:49527-750-027 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/2002
Labeler - CLINIQUE LABORATORIES INC (173047747)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD205952385manufacture
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326manufacture
Establishment
NameAddressID/FEIBusiness Operations
Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aramis Inc.042918826manufacture
Establishment
NameAddressID/FEIBusiness Operations
Northtec Bristol949264774manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Northtec Keystone618107429manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics, Ltd.255175580manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics, Ltd253616536manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Distribution Center208579636repack, relabel
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Kabushiki Kaisha712808195relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Whitman Laboratories Ltd.216866277manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058manufacture

Revised: 9/2011
Document Id: 99eda414-2647-4c41-8deb-7bf2b99141be
Set id: e6f428cc-3d6f-43a4-a893-0453ec1f4c59
Version: 2
Effective Time: 20110913
 
CLINIQUE LABORATORIES INC