Label: EXTRA REPAIR FOUNDATION BROAD SPECTRUM SPF 25- octinoxate, homosalate, oxybenzone, avobenzone cream

  • 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 April 6, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Avobenzone 2.00%
    Homosalate 5.00%
    Octinoxate 7.50%
    Oxybenzone 5.00%

  • Purpose

    Sunscreen

  • Use

    helps prevent sunburn

  • Warnings

    For external use only

    Do not use on damaged or broken skin

    When using this product keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if rash oocurs

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • 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, regulary 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-sleezed shirts, pants, hats and sunglasses
    • children under 6 months of age: ask a doctor
  • 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 • dicetylphosphate • 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

    protect the product in this container from excessive heat and direct sun.

  • SPL UNCLASSIFIED SECTION

    Dist. Bobbi Brown Professional Cosmetics,
    New York

  • PRINCIPAL DISPLAY PANEL - 30 ml Jar Carton

    BOBBI BROWN
    EXTRA

    Repair Foundation
    Broad Spectrum SPF 25

    1 FL. OZ./30 ml e

    Principal Display Panel - 30 ml Jar Carton
  • INGREDIENTS AND APPEARANCE
    EXTRA REPAIR FOUNDATION  BROAD SPECTRUM SPF 25
    octinoxate, homosalate, oxybenzone, avobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64141-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5.0 mL  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5.0 mL  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.0 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
    CARROT (UNII: L56Z1JK48B)  
    CHAMAEMELUM NOBILE (UNII: 7NF3GE7IWR)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    SQUALANE (UNII: GW89575KF9)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE GLYCOL MONOPALMITOSTEARATE (UNII: F76354LMGR)  
    SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64141-008-011 in 1 CARTON
    1NDC:64141-008-0230 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2010
    Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)
    Establishment
    NameAddressID/FEIBusiness Operations
    ELGC K.K.712808195RELABEL(64141-008) , REPACK(64141-008)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(64141-008) , RELABEL(64141-008) , REPACK(64141-008)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Inc.042918826MANUFACTURE(64141-008)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK(64141-008) , RELABEL(64141-008)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE(64141-008)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(64141-008)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(64141-008)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER N.V.370151326MANUFACTURE(64141-008)
    Establishment
    NameAddressID/FEIBusiness Operations
    LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(64141-008)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTEC KEYSTONE943871157MANUFACTURE(64141-008) , RELABEL(64141-008) , REPACK(64141-008)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC BRISTOL959338336MANUFACTURE(64141-008) , RELABEL(64141-008) , REPACK(64141-008)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC KEYSTONE949264774MANUFACTURE(64141-008) , RELABEL(64141-008) , REPACK(64141-008)
    Establishment
    NameAddressID/FEIBusiness Operations
    WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(64141-008)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aveda Corporation071352058MANUFACTURE(64141-008)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pennsylvania Logistics Center078364654REPACK(64141-008) , RELABEL(64141-008)
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