Label: BOBBI BROWN EXTRA TINTED MOISTURIZING BALM SPF 25- octinoxate, homosalate, oxybenzone, avobenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 64141-814-01, 64141-814-02 - 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 June 7, 2012
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENTS:
- PURPOSE
- USE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- SPL UNCLASSIFIED SECTION
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DIRECTIONS
For sunscreen use:
* apply liberally 15 minutes before sun exposure
* reapply at least every two hours
* use a water resistant sunscreen if swimming or sweating
* Sun Protection Measures.
Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
o limit time in the sun, especially from 10 a.m.–2 p.m.
o wear long-sleeved shirts, pants, hats and sunglasses
* children under 6 months of age: ask a doctor -
INACTIVE INGREDIENTS
INGREDIENTS: WATER\AQUA\EAU [] GLYCERIN [] PEG-4 DIHEPTANOATE [] BIS-DIGLYCERYL POLYACYLADIPATE-2 [] BUTYROSPERMUM PARKII (SHEA BUTTER) [] CETEARYL ALCOHOL [] CETYL ALCOHOL [] GLYCERYL STEARATE [] HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER [] EPILOBIUM ANGUSTIFOLIUM EXTRACT [] SODIUM HYALURONATE [] TOCOPHERYL ACETATE [] SQUALANE [] ETHYLHEXYLGLYCERIN [] OENOTHERA BIENNIS (EVENING PRIMROSE) OIL [] ROSMARINUS OFFICINALIS (ROSEMARY) [] ANTHEMIS NOBILIS (CHAMOMILE) [] PELARGONIUM GRAVEOLENS (GERANIUM) FLOWER OIL [] ANGELICA ARCHANGELICA SEED OIL [] CITRUS AURANTIUM AMARA (BITTER ORANGE) OIL [] PHENYL TRIMETHICONE [] DIMETHICONE [] LECITHIN [] BUTYLENE GLYCOL [] PEG-12 DIMETHICONE [] DICETYL PHOSPHATE [] CETETH-10 PHOSPHATE [] ASTROCARYUM MURUMURU SEED BUTTER [] SORBITAN STEARATE [] POLYSORBATE 60 [] PEG-40 STEARATE [] CITRUS GRANDIS (GRAPEFRUIT) PEEL OIL [] ALUMINA [] PROPYLENE GLYCOL STEARATE [] POLYSORBATE 20 [] ACETYL HEXAPEPTIDE-8 [] SORBITAN LAURATE [] PROPYLENE GLYCOL LAURATE [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] XANTHAN GUM [] CITRIC ACID [] TETRASODIUM EDTA [] POTASSIUM SORBATE [] CHLORPHENESIN [] PHENOXYETHANOL [] LIMONENE [] CITRONELLOL [] GERANIOL [] LINALOOL [] CITRAL [] [+/- TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] MICA
- OTHER INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BOBBI BROWN EXTRA TINTED MOISTURIZING BALM SPF 25
octinoxate, homosalate, oxybenzone, avobenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64141-814 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 mL in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5 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) GLYCERIN (UNII: PDC6A3C0OX) PEG-4 DIHEPTANOATE (UNII: 2DQ7O61VHJ) SHEA BUTTER (UNII: K49155WL9Y) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D) HYALURONATE SODIUM (UNII: YSE9PPT4TH) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SQUALANE (UNII: GW89575KF9) EVENING PRIMROSE OIL (UNII: 3Q9L08K71N) ROSEMARY (UNII: IJ67X351P9) CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC) ANGELICA SEED OIL (UNII: 67IO7RRV7A) CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) DIMETHICONE (UNII: 92RU3N3Y1O) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N) CETETH-10 PHOSPHATE (UNII: 4E05O5N49G) ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) POLYSORBATE 60 (UNII: CAL22UVI4M) PEG-40 STEARATE (UNII: ECU18C66Q7) CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44) ALUMINUM OXIDE (UNII: LMI26O6933) PROPYLENE GLYCOL STEARATE (UNII: MZM1I680W0) POLYSORBATE 20 (UNII: 7T1F30V5YH) ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL) SORBITAN MONOLAURATE (UNII: 6W9PS8B71J) PROPYLENE GLYCOL MONOLAURATE (UNII: 668Z5835Z3) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) XANTHAN GUM (UNII: TTV12P4NEE) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE SODIUM (UNII: MP1J8420LU) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CHLORPHENESIN (UNII: I670DAL4SZ) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64141-814-01 1 in 1 CARTON 1 NDC:64141-814-02 30 mL in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2004 Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279) Establishment Name Address ID/FEI Business Operations Len-Ron Manufacturing Division of Aramis Inc. 809771152 manufacture Establishment Name Address ID/FEI Business Operations Estee Lauder Inc 042918826 manufacture Establishment Name Address ID/FEI Business Operations Northtec Keystone 949264774 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Northtec Bristol 959338336 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Northtec Keystone 943871157 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. 205952385 manufacture Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics, Ltd. 244669714 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 Centre 208579636 repack, relabel Establishment Name Address ID/FEI Business Operations ELGC K.K. 712808195 relabel, repack Establishment Name Address ID/FEI Business Operations Estee Lauder N.V. 370151326 manufacture Establishment Name Address ID/FEI Business Operations Whitman Laboratories Ltd. 216866277 manufacture Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 manufacture Establishment Name Address ID/FEI Business Operations Pennsylvania Logistics Center (PALC) 078364654 repack, relabel