DERMA WHITE CITY BLOCK ANTI-POLLUTION SPF40

Dosage form: cream
Ingredients: OCTINOXATE 7.5mL in 100mL, TITANIUM DIOXIDE 5.2mL in 100mL, OCTISALATE 2.0mL in 100mL
Labeler: CLINIQUE LABS INC
NDC Code: 49527-008

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.

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


 

 
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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 mL  in 100 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE5.2 mL  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE2.0 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
BUTYLENE GLYCOL 
CETYL ALCOHOL 
CHAMAEMELUM NOBILE 
HIGH DENSITY POLYETHYLENE 
LECITHIN, SOYBEAN 
SQUALANE 
.ALPHA.-TOCOPHEROL ACETATE, DL-  
POLYSORBATE 20 
Packaging
#Item CodePackage Description
1NDC:49527-008-011 TUBE (TUBE) 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/FEIOperations
ESTEE LAUDER COSMETICS, LTD205952385manufacture
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER N.V.370151326manufacture
Establishment
NameAddressID/FEIOperations
Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
Establishment
NameAddressID/FEIOperations
Aramis Inc.042918826manufacture
Establishment
NameAddressID/FEIOperations
Northtec Bristol949264774manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Northtec Keystone618107429manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics, Ltd.255175580manufacture
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics, Ltd253616536manufacture
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics Distribution Center208579636repack, relabel
Establishment
NameAddressID/FEIOperations
Estee Lauder Kabushiki Kaisha712808195relabel, repack
Establishment
NameAddressID/FEIOperations
Whitman Laboratories Ltd.216866277manufacture
Establishment
NameAddressID/FEIOperations
Aveda Corporation071352058manufacture

Revised: 02/2011
 
CLINIQUE LABS INC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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