DERMA WHITE CITY BLOCK ANTI-POLLUTION SPF40- octinoxate, titanium dioxide, octisalate cream 
CLINIQUE LABS 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 ingredients: octinoxate 7.50% [] titanium dioxide 5.20% [] octisalate 2.00%

inactive ingredients: water [] butylene glycol [] c12-15 alkyl benzoate [] cetyl alcohol [] laureth-4 [] chamomilla recutita (matricaria) extract [] saccharomyces cerevisiae extract [] rosmarinus officinalis (rosemary) leaf extract [] chamomilla recutita (matricaria) flower extract [] gentiana lutea (gentian) root extract [] yeast extract\faex\extrait de levure [] oryza sativa (rice) bran extract [] polyethylene [] hordeum vulgare (barley) extract\extrait d'orge [] salicornia herbacea extract [] rosa roxburghii fruit extract [] peg-100 stearate [] citrus unshiu peel extract [] cucumis sativus (cucumber) fruit extract [] plankton extract [] pantethine [] porphyra yezoensis (algae) extract [] helianthus annuus (sunflower) seedcake [] hydrogenated lecithin [] caffeine [] polyglyceryl-3 beeswax [] acetyl glucosamine [] pvp/hexadecene copolymer [] squalane [] polyhydroxystearic acid [] tocopheryl acetate [] isohexadecane [] methicone [] propylene glycol dicaprate [] dipotassium glycyrrhizate [] zeolite [] nylon-12 [] magnesium ascorbyl phosphate [] polysorbate 80 [] hexylene glycol [] caprylyl glycol [] acrylamide/sodium acryloyldimethyltaurate copolymer [] isostearic acid [] calcium chloride [] xanthan gum [] alumina [] disodium edta [] bht [] phenoxyethanol [] zinc oxide (ci 77947) [] iron oxides (ci 77491, ci 77492, ci 77499)

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


keep out of reach of children.

PRINCIPAL DISPLAY PANEL:


CLINIQUE

DERMA WHITE

CITY BLOCK

ANTI-POLLUTION SPF 40


ALL SKIN TYPES


1 FL OZ LIQ / 30 ML


CLINIQUE LABS DISTR.
NEW YORK, NY 10022


 
FOLDING CARTON

 
DERMA WHITE  CITY BLOCK ANTI-POLLUTION SPF40
octinoxate, titanium dioxide, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.2 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.0 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CHAMAEMELUM NOBILE (UNII: 7NF3GE7IWR)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SQUALANE (UNII: GW89575KF9)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49527-008-011 in 1 CARTON
1NDC:49527-008-0230 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/01/2010
Labeler - CLINIQUE LABS 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: 2/2011
Document Id: ff0d1114-24c2-4367-a60d-b1e144649925
Set id: 97ceb066-d93a-4be7-90ec-6f82965501b3
Version: 1
Effective Time: 20110211
 
CLINIQUE LABS INC