![EXTRA REPAIR MOISTURING BALM SPF 25 (OCTINOXATE, HOMOSALATE, OXYBENZONE, AVOBENZONE) CREAM [BOBBI BROWN PROFESSIONAL COSMETICS INC.]](https://medic.hrt.org//dailymed/images/1e73c840-d69c-4e34-a6c0-00203ab3c24b/E7JG.jpg)
| NDC | 64141-112-01, 64141-112-02 |
| Set ID | 1e73c840-d69c-4e34-a6c0-00203ab3c24b |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Bobbi Brown Professional Cosmetics Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- 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
