EXTRA REPAIR MOISTURING BALM SPF 25- octinoxate, homosalate, oxybenzone, avobenzone cream

EXTRA by

Drug Labeling and Warnings

EXTRA by is a Otc medication manufactured, distributed, or labeled by Bobbi Brown Professional Cosmetics Inc., ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER N.V., Len-Ron Manufacturing Division of Aramis Inc., Aramis Inc., Northtec Bristol, Northtec Keystone, Estee Lauder Pennsylvania Distribution Center 2, Estee Lauder Cosmetics, Ltd., Estee Lauder Cosmetics, Ltd, Estee Lauder Cosmetics Distribution Center, Estee Lauder Kabushiki Kaisha, Whitman Laboratories Ltd., Aveda Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS: OCTINOXATE 7.50% [] HOMOSALATE 5.00% [] OXYBENZONE 3.00% [] AVOBENZONE 2.00%

INACTIVE INGREDIENT

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

WARNINGS

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

PRINCIPAL DISPLAY PANEL

BOBBI BROWN

EXTRA

REPAIR MOISTURIZING

BALM SPF 25

1.7 OZ./50 ML

DISTR. BOBBI BROWN PROFESSIONAL COSMETICS

NEW YORK, NY 10022

INGREDIENTS AND APPEARANCE

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

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