RICH LIP COLOR SPF 12

Dosage form: lipstick
Ingredients: OCTINOXATE 5.0g in 100g, OCTISALATE 2.5g in 100g
Labeler: Bobbi Brown Professional Cosmetics Inc.
NDC Code: 64141-009

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 5.00% [] OCTISALATE 2.50%

INACTIVE INGREDIENTS: OCTYLDODECANOL [] TRIISOSTEARIN [] DIISOSTEARYL MALATE [] DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE [] MICROCRYSTALLINE WAX [] POLYETHYLENE [] POLYBUTENE [] PARAFFIN [] VP/HEXADECENE COPOLYMER [] CAPRYLIC/CAPRIC TRIGLYCERIDE [] HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER [] OZOKERITE [] DICALCIUM PHOSPHATE [] IRVINGIA GABONENSIS KERNEL BUTTER [] OCTYLDODECYL PCA [] HYDROGENATED COCO-GLYCERIDES [] DIPALMITOYL HYDROXYPROLINE [] STEARALKONIUM BENTONITE [] ETHYL VANILLIN [] PROPYLENE CARBONATE [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] TOCOPHEROL [] SILICA []  [+/- MICA [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] RED 7 LAKE (CI 15850) [] BLUE 1 LAKE (CI 42090) [] YELLOW 5 LAKE (CI 19140) [] YELLOW 10 (CI 47005) [] RED 22 LAKE (CI 45380) [] RED 30 LAKE (CI 73360) [] CARMINE (CI 75470) [] TITANIUM DIOXIDE (CI 77891) [] RED 30 (CI 73360) [] RED 6 (CI 15850) [] YELLOW 6 LAKE (CI 15985) [] RED 33 LAKE (CI 17200) [] RED 21 (CI 45380) [] ORANGE 5 (CI 45370) [] RED 28 LAKE (CI 45410) [] YELLOW 5 (CI 19140) [] YELLOW 10 LAKE (CI 47005) [] BRONZE POWDER (CI 77400) [] RED 22 (CI 45380)

WARNING: STOP USE IF IRRITATION OCCURS.

BOBBI BROWN

RICH LIP COLOR SPF 12


NET WT. 0.13 oz/ 3.8 g



Distr. Bobbi Brown Professional Cosmetics

New York, NY 10022

RICH LIP COLOR  SPF 12
octinoxate, octisalate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64141-009
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE5.0 g  in 100 g
OCTISALATE (OCTISALATE) OCTISALATE2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
OCTYLDODECANOL 
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE  
MICROCRYSTALLINE WAX 
HIGH DENSITY POLYETHYLENE 
POLYBUTENE (1400 MW) 
PARAFFIN 
MEDIUM-CHAIN TRIGLYCERIDES 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
IRVINGIA GABONENSIS SEED 
HYDROGENATED COCONUT OIL 
DIPALMITOYL HYDROXYPROLINE 
VANILLIN 
PROPYLENE CARBONATE 
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) 
TOCOPHEROL 
SILICON DIOXIDE 
MICA 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
D&C RED NO. 7 
COCHINEAL 
Packaging
#Item CodePackage Description
1NDC:64141-009-011 CARTRIDGE (CARTRIDGE) in 1 CARTON
1NDC:64141-009-023.8 g in 1 CARTRIDGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2010
Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)
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
Establishment
NameAddressID/FEIOperations
Intercos 338578473manufacture

Revised: 06/2011
 
Bobbi Brown Professional Cosmetics 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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