EXTRA REPAIR MOISTURIZING BALM BROAD SPECTRUM SPF 25 (OCTINOXATE, HOMOSALATE, OXYBENZONE, AND AVOBENZONE) CREAM [BOBBI BROWN PROFESSIONAL COSMETICS INC.]

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  • EXTRA REPAIR MOISTURIZING BALM BROAD SPECTRUM SPF 25 (OCTINOXATE, HOMOSALATE, OXYBENZONE, AND AVOBENZONE) CREAM [BOBBI BROWN PROFESSIONAL COSMETICS INC.]

EXTRA REPAIR MOISTURIZING BALM BROAD SPECTRUM SPF 25 (OCTINOXATE, HOMOSALATE, OXYBENZONE, AND AVOBENZONE) CREAM [BOBBI BROWN PROFESSIONAL COSMETICS INC.]
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NDC 64141-026-01
Set ID 90317b6f-a389-4b97-bb90-c2ce67ca4417
Category HUMAN OTC DRUG LABEL
Packager Bobbi Brown Professional Cosmetics Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Avobenzone 2.00%
    Homosalate 5.00%
    Octinoxate 7.50%
    Oxybenzone 3.00%

  • 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 occurs

    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, 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
  • Inactive ingredients

    water\aqua\eau • 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 <iln38186>

  • Other information

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

  • PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

    BOBBI BROWN
    EXTRA

    Repair Moisturizing Balm
    Broad Spectrum SPF 25

    1.7 FL. OZ./50 ml e

    PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton
  • INGREDIENTS AND APPEARANCE
    EXTRA REPAIR MOISTURIZING BALM BROAD SPECTRUM SPF 25 
    octinoxate, homosalate, oxybenzone, and avobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64141-026
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3 g  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    C12-15 ALKYL ETHYLHEXANOATE (UNII: GQJ580CH83)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    SUCROSE (UNII: C151H8M554)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CLARY SAGE (UNII: U3HSK5JC0Q)  
    WHEAT BRAN (UNII: 6L966A1IMR)  
    PEA (UNII: W4X7H8GYFM)  
    ROSEMARY (UNII: IJ67X351P9)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
    CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)  
    BITTER ORANGE OIL (UNII: 9TLV70SV6I)  
    CHAMOMILE (UNII: FGL3685T2X)  
    WHEY (UNII: 8617Z5FMF6)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    CAFFEINE (UNII: 3G6A5W338E)  
    ACETYL HEXAPEPTIDE-8 (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)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    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)  
    GERANIOL (UNII: L837108USY)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CITRAL (UNII: T7EU0O9VPP)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64141-026-011 in 1 CARTON08/16/2011
    150 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35208/16/2011
    Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    Whitman Laboratories Ltd.216866277MANUFACTURE(64141-026) , REPACK(64141-026) , RELABEL(64141-026)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COMPANY, THE828534516REPACK(64141-026) , RELABEL(64141-026)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Ltd.202952982MANUFACTURE(64141-026) , REPACK(64141-026) , RELABEL(64141-026)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Ltd.204132062REPACK(64141-026) , RELABEL(64141-026)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder N.V.370151326MANUFACTURE(64141-026) , REPACK(64141-026) , RELABEL(64141-026)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC INC943871157REPACK(64141-026) , RELABEL(64141-026)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC PALC102631997REPACK(64141-026) , RELABEL(64141-026)
    Establishment
    NameAddressID/FEIBusiness Operations
    Len-Ron Manufacturing Division of Aramis Inc.809771152MANUFACTURE(64141-026) , REPACK(64141-026) , RELABEL(64141-026)
    Establishment
    NameAddressID/FEIBusiness Operations
    PADC 1949264774REPACK(64141-026) , RELABEL(64141-026)
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