CONTINUOUS COVERAGE MAKEUP SPF 15- 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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DRUG FACTS

ACTIVE INGREDIENT: 2% TITANIUM DIOXIDE

PURPOSE: SUNSCREEN

USE: HELPS PREVENT SUNBURN

WARNINGS:

FOR EXTERNAL USE ONLY


DO NOT USE ON DAMAGED OR BROKEN SKIN

WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

STOP USE AND ASK A DOCTOR IF RASH OCCURS

KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

INACTIVE INGREDIENTS: water\aqua\eau [] polydecene [] talc [] butylene glycol [] isostearic acid [] glyceryl stearate [] peg-100 stearate [] phenyl trimethicone [] magnesium aluminum silicate [] tromethamine [] cholesterol [] algin [] microcrystalline cellulose [] cellulose gum [] disteardimonium hectorite [] sodium hyaluronate [] triethyl citrate [] lecithin [] stearic acid [] aluminum hydroxide [] polyaminopropyl biguanide [] phenoxyethanol []  [+/- mica [] titanium dioxide (ci 77891) [] iron oxides (ci 77491, ci 77492, ci 77499) [] bismuth oxychloride (ci 77163)

PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN

PRINCIPAL DISPLAY PANEL



CLINIQUE

CONTINUOUS

COVERAGE

MAKEUP

BROAD SPECTRUM

SPF 15

NET WT. 1 OZ/ 30 ML


CLINIQUE LABORATORIES DIST
NY NY 10022
FOLDING CARTON

CONTINUOUS COVERAGE MAKEUP  SPF 15
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.0 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
TALC (UNII: 7SEV7J4R1U)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
TROMETHAMINE (UNII: 023C2WHX2V)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
SODIUM ALGINATE (UNII: C269C4G2ZQ)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MICA (UNII: V8A1AW0880)  
IRON (UNII: E1UOL152H7)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49527-010-011 in 1 CARTON
1NDC:49527-010-0230 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/1992
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: 12/2011
Document Id: 57a20355-aa90-462f-b51e-68616a1a555d
Set id: 4ba50cf4-b3d3-4b87-80da-483a006f694e
Version: 2
Effective Time: 20111219
 
CLINIQUE LABORATORIES INC