REDNESS SOLUTIONS MAKEUP SPF 15 WITH PROBIOTIC TECHNOLOGY

Dosage form: lotion
Ingredients: OCTINOXATE 5.9mL in 100mL, ZINC OXIDE 3.7mL in 100mL, TITANIUM DIOXIDE 2.9mL in 100mL
Labeler: CLINIQUE LABORATORIES INC
NDC Code: 49527-005

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 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


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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE5.9 mL  in 100 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE3.7 mL  in 100 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE2.9 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
METHYL TRIMETHICONE 
PHENYL TRIMETHICONE 
DIMETHICONE 
TRIETHYLHEXANOIN 
BUTYLENE GLYCOL 
TRIMETHOXYCAPRYLYLSILANE 
ALUMINUM HYDROXIDE 
ALKYL (C12-15) BENZOATE 
LACTOBACILLUS HELVETICUS 
CITRUS MAXIMA FRUIT RIND 
MAGNOLIA GRANDIFLORA BARK 
FU LING 
ASTROCARYUM MURUMURU SEED BUTTER 
GLYCERIN 
CAFFEINE 
SODIUM MYRISTOYL ISETHIONATE 
LECITHIN, SOYBEAN 
ALPHA-TOCOPHEROL ACETATE 
LAURETH-7 
SODIUM CHLORIDE 
DIPROPYLENE GLYCOL 
EDETATE DISODIUM 
POLYAMINOPROPYL BIGUANIDE 
PHENOXYETHANOL 
MICA 
FERRIC OXIDE RED 
Packaging
#Item CodePackage Description
1NDC:49527-005-011 BOTTLE (BOTTLE) 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/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: 07/2011
 
CLINIQUE LABORATORIES 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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