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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:64141-112-01	1 in 1 CARTON
1	NDC:64141-112-02	50 mL in 1 JAR

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	08/16/2011

Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER COSMETICS, LTD		205952385	manufacture

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER N.V.		370151326	manufacture

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Len-Ron Manufacturing Division of Aramis Inc.		809771152	manufacture

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Northtec Keystone		618107429	manufacture, relabel, repack

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Estee Lauder Pennsylvania Distribution Center 2		828534516	manufacture, relabel, repack

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Establishment
Estee Lauder Cosmetics, Ltd.		255175580	manufacture

Name	Address	ID/FEI	Business Operations
Establishment
Estee Lauder Cosmetics, Ltd		253616536	manufacture

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Establishment
Estee Lauder Cosmetics Distribution Center		208579636	repack, relabel

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Establishment
Estee Lauder Kabushiki Kaisha		712808195	relabel, repack

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Establishment
Whitman Laboratories Ltd.		216866277	manufacture

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Establishment
Aveda Corporation		071352058	manufacture