REDNESS SOLUTIONS MAKEUP SPF 15 WITH PROBIOTIC TECHNOLOGY- octinoxate, titanium dioxide, zinc oxide lotion 
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 5.90% [] titanium dioxide 3.70% [] zinc oxide 2.90%


inactive ingredients: water [] methyl trimethicone [] phenyl trimethicone [] dimethicone [] triethylhexanoin [] butylene glycol [] trimethylsiloxysilicate [] peg-10 dimethicone [] lauryl peg-9 polydimethylsiloxyethyl dimethicone [] aluminum hydroxide [] c12-15 alkyl benzoate [] lactobacillus ferment [] citrus grandis (grapefruit) peel extract [] magnolia grandiflora bark extract [] poria cocos sclerotium extract [] astrocaryum murumuru seed butter [] glycerin [] caffeine [] sodium myristoyl sarcosinate [] caprylyl methicone [] methicone [] polyglyceryl-6 polyricinoleate [] disteardimonium hectorite [] acetyl glucosamine [] isopropyl titanium triisostearate [] dimethicone crosspolymer-3 [] lecithin [] tocopheryl acetate [] laureth-7 [] dimethicone/peg-10/15 crosspolymer [] sodium chloride [] dipropylene glycol [] disodium edta [] polyaminopropyl biguanide [] phenoxyethanol []  [+/- mica [] titanium dioxide (ci 77891) [] iron oxides (ci 77491, ci 77492, ci 77499)]

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

principal display panel:

CLINIQUE

REDNESS

SOLUTIONS

MAKE UP SPF 15

with probiotic technology

1 fl oz liq/ 30 ml


clinique laboratories, dist

new york, ny 10022

folding carton


REDNESS SOLUTIONS MAKEUP  SPF 15 WITH PROBIOTIC TECHNOLOGY
octinoxate, titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5.9 mL  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.7 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.9 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
LACTOBACILLUS HELVETICUS (UNII: Q08Z44662J)  
CITRUS MAXIMA FRUIT RIND (UNII: 5NX3G75CA6)  
MAGNOLIA GRANDIFLORA BARK (UNII: J4XF5T6418)  
FU LING (UNII: XH37TWY5O4)  
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CAFFEINE (UNII: 3G6A5W338E)  
SODIUM MYRISTOYL ISETHIONATE (UNII: 8D42TA2T6V)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
LAURETH-7 (UNII: Z95S6G8201)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49527-005-011 in 1 CARTON
1NDC:49527-005-0230 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/01/2010
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: 7/2011
Document Id: 651ed07d-d801-458b-bb84-3ca903a55303
Set id: 361d7f45-22f4-440f-b9e6-312618e48298
Version: 1
Effective Time: 20110707
 
CLINIQUE LABORATORIES INC