RICH LIP COLOR SPF 12- octinoxate, octisalate lipstick 
Bobbi Brown Professional Cosmetics 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 5.00% [] 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

folding carton

RICH LIP COLOR  SPF 12
octinoxate, octisalate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64141-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5.0 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
OCTYLDODECANOL (UNII: 461N1O614Y)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
PARAFFIN (UNII: I9O0E3H2ZE)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
IRVINGIA GABONENSIS SEED (UNII: 0J4W1PR213)  
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
VANILLIN (UNII: CHI530446X)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICA (UNII: V8A1AW0880)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
COCHINEAL (UNII: TZ8Z31B35M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64141-009-011 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/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
Intercos 338578473manufacture

Revised: 6/2011
Document Id: dcdbafc6-92ef-4ca4-b0a3-3c5a1ae49080
Set id: 65800a35-be93-4680-9044-f3cf71ffcd9c
Version: 1
Effective Time: 20110606
 
Bobbi Brown Professional Cosmetics Inc.