ALMOST POWDER MAKEUP SPF 15- titanium dioxide, octinoxate powder 
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: titanium dioxide 13.00% [] octinoxate 2.00%

inactive ingredients: talc [] dimethicone [] nylon-12 [] silica [] squalane [] boron nitride [] vinyl dimethicone/methicone silsesquioxane crosspolymer [] cetyl caprylate [] diisostearyl malate [] phytosteryl/isostearyl/cetyl/stearyl/behenyl  dimer dilinoleate [] methicone [] aluminum hydroxide [] glycerin [] sodium hyaluronate [] magnesium palmitoyl glutamate [] sodium palmitoyl sarcosinate [] palmitoyl proline [] alumina [] tocopherol [] palmitic acid [] 1,2-hexanediol [] ascorbyl tetraisopalmitate [] tin oxide [] sodium dehydroacetate []  [+/- iron oxides (ci 77499, ci 77492, ci 77491) [] mica [] titanium dioxide (ci 77891)]

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

principal display panel:



CLINIQUE

ALMOST POWDER MAKEUP

SPF 15



NT WT. 0.35 OZ/ 10 g


clinique laboratories dist.
new york, ny 10022
folding carton



ALMOST POWDER MAKEUP  SPF 15
titanium dioxide, octinoxate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-800
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE13.0 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TALC (UNII: 7SEV7J4R1U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SQUALANE (UNII: GW89575KF9)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
CETYL OCTANOATE (UNII: 418Q5V6PLJ)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SODIUM PALMITOYL GLUTAMATE (UNII: KVF4175O54)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
TOCOPHEROL (UNII: R0ZB2556P8)  
PALMITIC ACID (UNII: 2V16EO95H1)  
HEXANEDIOL (UNII: ZIA319275I)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
TIN (UNII: 387GMG9FH5)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MICA (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49527-800-011 in 1 CELLO PACK
1NDC:49527-800-0210 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/2007
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
Establishment
NameAddressID/FEIBusiness Operations
ASANUMA CORP LTD700717762manufacture

Revised: 6/2011
Document Id: 9d821a45-3ceb-4b8c-a58c-08dc973fb934
Set id: 790d046c-2b73-4f98-b984-591d962dcc12
Version: 1
Effective Time: 20110621
 
CLINIQUE LABORATORIES INC