Label: BOBBI BROWN EXTRA REPAIR FOUNDATION BROAD SPECTRUM SPF 25- octinoxate, homosalate, oxybenzone, and avobenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 64141-015-01 - Packager: Bobbi Brown Professional Cosmetics Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 August 12, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Use
- Warnings
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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
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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:
- limit time in the sun, especially from 10 a.m.–2 p.m.
- wear long-sleeved shirts, pants, hats and sunglasses
- children under 6 months of age: ask a doctor
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Inactive ingredients
water\aqua\eau ▪ glycerin ▪ bis-diglyceryl polyacyladipate-2 ▪ butyrospermum parkii (shea butter) ▪ peg-4 diheptanoate ▪ cetearyl alcohol ▪ cetyl alcohol ▪ glyceryl stearate ▪ hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer ▪ epilobium angustifolium extract ▪ rosmarinus officinalis (rosemary) ▪ oenothera biennis (evening primrose) oil ▪ pelargonium graveolens (geranium) flower oil ▪ angelica archangelica seed oil ▪ citrus aurantium amara (bitter orange) oil ▪ astrocaryum murumuru seed butter ▪ anthemis nobilis (chamomile) ▪ acetyl hexapeptide-8 ▪ lecithin ▪ dimethicone ▪ phenyl trimethicone ▪ propylene glycol laurate ▪ sorbitan stearate ▪ peg-40 stearate ▪ squalane ▪ ethylhexylglycerin ▪ butylene glycol ▪ dicetyl phosphate ▪ ceteth-10 phosphate ▪ polysorbate 60 ▪ peg-12 dimethicone ▪ citrus grandis (grapefruit) peel oil ▪ propylene glycol stearate ▪ sodium hyaluronate ▪ sorbitan laurate ▪ polysorbate 20 ▪ citric acid ▪ tocopheryl acetate ▪ xanthan gum ▪ alumina ▪ pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate ▪ tetrasodium edta ▪ limonene ▪ linalool ▪ citral ▪ geraniol ▪ citronellol ▪ potassium sorbate ▪ phenoxyethanol ▪ chlorphenesin ▪ [+/- titanium dioxide (ci 77891) ▪ iron oxides (ci 77491, ci 77492, ci 77499) ▪ mica] <iln38338>
- Other information
- PRINCIPAL DISPLAY PANEL - 30 ml Jar Carton
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INGREDIENTS AND APPEARANCE
BOBBI BROWN EXTRA REPAIR FOUNDATION BROAD SPECTRUM SPF 25
octinoxate, homosalate, oxybenzone, and avobenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64141-015 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0821 g in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 0.0548 g in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0548 g in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.0219 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) SHEA BUTTER (UNII: K49155WL9Y) PEG-4 DIHEPTANOATE (UNII: 2DQ7O61VHJ) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ROSEMARY (UNII: IJ67X351P9) EVENING PRIMROSE OIL (UNII: 3Q9L08K71N) PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC) ANGELICA SEED OIL (UNII: 67IO7RRV7A) CITRUS AURANTIUM FRUIT (UNII: DQD16J2B5O) ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R) CHAMOMILE (UNII: FGL3685T2X) ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL) DIMETHICONE (UNII: 92RU3N3Y1O) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PROPYLENE GLYCOL MONOLAURATE (UNII: 668Z5835Z3) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) PEG-40 STEARATE (UNII: ECU18C66Q7) SQUALANE (UNII: GW89575KF9) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N) CETETH-10 PHOSPHATE (UNII: 4E05O5N49G) POLYSORBATE 60 (UNII: CAL22UVI4M) CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44) PROPYLENE GLYCOL MONOSTEARATE (UNII: MZM1I680W0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SORBITAN MONOLAURATE (UNII: 6W9PS8B71J) POLYSORBATE 20 (UNII: 7T1F30V5YH) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) XANTHAN GUM (UNII: TTV12P4NEE) ALUMINUM OXIDE (UNII: LMI26O6933) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) EDETATE SODIUM (UNII: MP1J8420LU) LINALOOL, (+/-)- (UNII: D81QY6I88E) CITRAL (UNII: T7EU0O9VPP) GERANIOL (UNII: L837108USY) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PHENOXYETHANOL (UNII: HIE492ZZ3T) CHLORPHENESIN (UNII: I670DAL4SZ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64141-015-01 1 in 1 CARTON 11/01/2010 1 30 mL in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 11/01/2010 Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations Whitman Laboratories Ltd. 216866277 MANUFACTURE(64141-015) , REPACK(64141-015) , RELABEL(64141-015) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COMPANY, THE 828534516 REPACK(64141-015) , RELABEL(64141-015) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 202952982 MANUFACTURE(64141-015) , REPACK(64141-015) , RELABEL(64141-015) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 204132062 REPACK(64141-015) , RELABEL(64141-015) Establishment Name Address ID/FEI Business Operations NORTHTEC INC 943871157 REPACK(64141-015) , RELABEL(64141-015) Establishment Name Address ID/FEI Business Operations NORTHTEC PALC 102631997 REPACK(64141-015) , RELABEL(64141-015) Establishment Name Address ID/FEI Business Operations Len-Ron Manufacturing Division of Aramis Inc. 809771152 MANUFACTURE(64141-015) , REPACK(64141-015) , RELABEL(64141-015) Establishment Name Address ID/FEI Business Operations PADC 1 949264774 REPACK(64141-015) , RELABEL(64141-015) Establishment Name Address ID/FEI Business Operations Estee Lauder N.V. 370151326 MANUFACTURE(64141-015) , REPACK(64141-015) , RELABEL(64141-015)
