CLINIQUE CX PROTECTIVE BASE SPF 40- octinoxate, octisalate, zinc oxide,titanium dioxide 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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active ingredients: octinoxate 7.50% [] octisalate 5.00% [] zinc oxide 4.60% [] titanium dioxide 1.70%

inactive ingredients: water (aqua purificata) purified [] butylene glycol [] c12-15 alkyl benzoate [] dimethicone [] jojoba esters [] caprylic/capric triglyceride [] cetearyl alcohol [] silica [] micrococcus lysate [] gentiana lutea (gentian) root extract [] coffea robusta seed extract [] helianthus annuus (sunflower) seedcake [] cucumis sativus (cucumber) fruit extract [] sea whip extract [] cholesterol [] astrocaryum murumuru butter [] hordeum vulgare (barley) extract [] linoleic acid [] butyrospermum parkii (shea butter) [] caffeine [] salvia sclarea (clary) extract [] sodium rna [] sodium hyaluronate [] phytosphingosine [] tocopheryl acetate [] sodium dna [] cetearyl glucoside [] zeolite [] stearic acid [] chamomilla recutita (matricaria) [] sucrose [] peg-100 stearate [] lecithin [] trehalose [] hydrogenated lecithin [] hexylene glycol [] propylene glycol dicaprate [] tricaprylin [] polyhydroxystearic acid [] polyethylene [] methyl gluceth-20 [] ethylhexyl stearate [] carbomer [] behenyl alcohol [] alumina [] ethylhexyl palmitate [] caprylyl glycol [] cetyl alcohol [] triethoxycaprylylsilane [] xanthan gum [] aluminum stearate [] disodium edta [] bht [] phenoxyethanol [] mica [] titanium dioxide (ci 77891) [] iron oxides (ci 77491, ci 77492, ci 77499)

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

keep out of reach of chidren

principal display panel:


CLINIQUE CX

PROTECTIVE BASE

SPF 40

CLINIQUE LABORATORIES

1.7 fl oz/50 ml


clinique laboratories, distr.
new york, ny
10022

clinique.com
folding carton



CLINIQUE CX  PROTECTIVE BASE SPF 40
octinoxate, octisalate, zinc oxide,titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-953
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.0 mL  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.6 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.7 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49527-953-011 in 1 CARTON
1NDC:49527-953-0250 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/01/2005
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: 11/2010
Document Id: 3db07dee-3ef4-417d-a4ac-1a18421ddcb4
Set id: 75201871-e084-48e0-9e18-a0b2bf280626
Version: 1
Effective Time: 20101103
 
CLINIQUE LABORATORIES INC