Label: EXTRA REPAIR MOISTURING BALM SPF 25- octinoxate, homosalate, oxybenzone, avobenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 64141-112-01, 64141-112-02 - Packager: Bobbi Brown Professional Cosmetics Inc.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated September 19, 2011
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- ACTIVE INGREDIENT
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EXTRA REPAIR MOISTURING BALM SPF 25
octinoxate, homosalate, oxybenzone, avobenzone creamProduct 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
