EXTRA REPAIR MOISTURING BALM SPF 25- octinoxate, homosalate, oxybenzone and avobenzone cream 
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 7.50% [] HOMOSALATE 5.00% [] OXYBENZONE 3.00% [] AVOBENZONE 2.00%

INACTIVE INGREDIENTS: WATER [] C12-15 ALKYL ETHYLHEXANOATE [] BUTYLOCTYL SALICYLATE [] BUTYROSPERMUM PARKII (SHEA BUTTER) [] PROPANEDIOL [] CETYL ALCOHOL [] CETEARYL ALCOHOL [] GLYCERYL STEARATE [] BIS-DIGLYCERYL POLYACYLADIPATE-2 [] POLYACRYLAMIDE [] TOCOPHERYL ACETATE [] NEOPENTYL GLYCOL DIHEPTANOATE [] SUCROSE [] POLYETHYLENE [] OLEA EUROPAEA (OLIVE) FRUIT EXTRACT [] SALVIA SCLAREA (CLARY) EXTRACT [] EPILOBIUM ANGUSTIFOLIUM EXTRACT [] TRITICUM VULGARE (WHEAT BRAN) EXTRACT [] PISUM SATIVUM (PEA) EXTRACT [] BAMBUSA VULGARIS (BAMBOO) EXTRACT [] ROSMARINUS OFFICINALIS (ROSEMARY) [] OENOTHERA BIENNIS (EVENING PRIMROSE) OIL [] PELARGONIUM GRAVEOLENS (GERANIUM) FLOWER OIL [] CITRUS GRANDIS (GRAPEFRUIT) PEEL OIL [] CITRUS AURANTIUM AMARA (BITTER ORANGE) OIL [] ANTHEMIS NOBILIS (CHAMOMILE) [] WHEY PROTEIN\LACTIS PROTEIN\PROTEINE DU PETIT-LAIT [] CHOLESTEROL [] LINOLEIC ACID [] CAFFEINE [] ACETYL HEXAPEPTIDE-8 [] SORBITAN STEARATE [] PEG-40 STEARATE [] C13-14 ISOPARAFFIN [] CAPRYLYL GLYCOL [] DICETYL PHOSPHATE [] CETETH-10 PHOSPHATE [] LAURETH-7 [] GLUCOSAMINE HCL [] TETRAHEXYLDECYL ASCORBATE [] SODIUM HYALURONATE [] SODIUM HYDROXIDE [] HEXYLENE GLYCOL [] XANTHAN GUM [] CITRIC ACID [] TETRASODIUM EDTA [] GERANIOL [] LINALOOL [] LIMONENE [] CITRAL [] CITRONELLOL [] PHENOXYETHANOL

WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS. KEEP OUT OF REACH OF CHILDREN.


BOBBI BROWN


EXTRA

REPAIR MOISTURIZING

BALM SPF 25



1.7 OZ./50 ML



DISTR. BOBBI BROWN PROFESSIONAL COSMETICS

NEW YORK, NY 10022

FOLDING CARTON

EXTRA  REPAIR MOISTURING BALM SPF 25
octinoxate, homosalate, oxybenzone, avobenzone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:64141-112
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mL  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 5.0 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 3.0 mL  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.0 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
SHEA BUTTER (UNII: K49155WL9Y)  
PROPANEDIOL (UNII: 5965N8W85T)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
SUCROSE (UNII: C151H8M554)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
BLACK OLIVE (UNII: 2M6QWV94OC)  
CLARY SAGE (UNII: U3HSK5JC0Q)  
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)  
WHEAT BRAN (UNII: 6L966A1IMR)  
PEA (UNII: W4X7H8GYFM)  
BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)  
ROSEMARY (UNII: IJ67X351P9)  
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
PELARGONIUM GRAVEOLENS FLOWERING TOP (UNII: 1P36QZP48P)  
CITRUS MAXIMA FRUIT RIND (UNII: 5NX3G75CA6)  
CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH)  
CHAMAEMELUM NOBILE (UNII: 7NF3GE7IWR)  
WHEY (UNII: 8617Z5FMF6)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
LINOLEIC ACID (UNII: 9KJL21T0QJ)  
CAFFEINE (UNII: 3G6A5W338E)  
ACETYL HEXAPEPTIDE-3 (UNII: L4EL31FWIL)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
LAURETH-7 (UNII: Z95S6G8201)  
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE SODIUM (UNII: MP1J8420LU)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:64141-112-01 1 in 1 CARTON
1 NDC:64141-112-02 50 mL in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 08/16/2011
Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)
Establishment
Name Address ID/FEI Business Operations
ESTEE LAUDER COSMETICS, LTD 205952385 manufacture
Establishment
Name Address ID/FEI Business Operations
ESTEE LAUDER N.V. 370151326 manufacture
Establishment
Name Address ID/FEI Business Operations
Len-Ron Manufacturing Division of Aramis Inc. 809771152 manufacture
Establishment
Name Address ID/FEI Business Operations
Aramis Inc. 042918826 manufacture
Establishment
Name Address ID/FEI Business Operations
Northtec Bristol 949264774 manufacture, relabel, repack
Establishment
Name Address ID/FEI Business Operations
Northtec Keystone 618107429 manufacture, relabel, repack
Establishment
Name Address ID/FEI Business Operations
Estee Lauder Pennsylvania Distribution Center 2 828534516 manufacture, relabel, repack
Establishment
Name Address ID/FEI Business Operations
Estee Lauder Cosmetics, Ltd. 255175580 manufacture
Establishment
Name Address ID/FEI Business Operations
Estee Lauder Cosmetics, Ltd 253616536 manufacture
Establishment
Name Address ID/FEI Business Operations
Estee Lauder Cosmetics Distribution Center 208579636 repack, relabel
Establishment
Name Address ID/FEI Business Operations
Estee Lauder Kabushiki Kaisha 712808195 relabel, repack
Establishment
Name Address ID/FEI Business Operations
Whitman Laboratories Ltd. 216866277 manufacture
Establishment
Name Address ID/FEI Business Operations
Aveda Corporation 071352058 manufacture

Revised: 9/2011
Document Id: 9a0492aa-8a22-4f7c-a501-d08440de8185
Set id: 1e73c840-d69c-4e34-a6c0-00203ab3c24b
Version: 1
Effective Time: 20110919
 
Bobbi Brown Professional Cosmetics Inc.