Label: LA MER THE REPARATIVE FACE SUN BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

  • NDC Code(s): 65966-011-01
  • Packager: MAX HUBER RESEARCH LAB 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 December 4, 2012

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredients

    Avobenzone 3.00%
    Homosalate 5.00%
    Octisalate 5.00%
    Octocrylene 2.70%
    Oxybenzone 2.50%

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  • Purpose

    Sunscreen

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  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun
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  • 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.

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  • Directions

    For sunscreen use:

    • apply liberally 15 minutes before sun exposure
    • reapply 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
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  • Inactive ingredients

    water\aqua\eau • dimethicone • butyloctyl salicylate • neopentyl glycol diheptanoate • butylene glycol • peg-100 stearate • dipentaerythrityl tri-polyhydroxystearate • silica • lauryl peg-9 polydimethylsiloxyethyl dimethicone • butyrospermum parkii (shea butter) • methyl trimethicone • phenyl trimethicone • trisiloxane • glyceryl stearate • potassium cetyl phosphate • algae (seaweed) extract • sesamum indicum (sesame) seed oil • medicago sativa (alfalfa) seed powder • helianthus annuus (sunflower) seedcake • prunus amygdalus dulcis (sweet almond) seed meal • eucalyptus globulus (eucalyptus) leaf oil • sodium gluconate • copper gluconate • calcium gluconate • magnesium gluconate • zinc gluconate • tocopheryl succinate • niacin • sesamum indicum (sesame) seed powder • laminaria ochroleuca extract • rosmarinus officinalis (rosemary) extract • citrus aurantifolia (lime) peel extract • cucumis sativus (cucumber) fruit extract • pyrus malus (apple) fruit extract • scutellaria baicalensis root extract • plankton extract • laurdimonium hydroxypropyl hydrolyzed soy protein • malachite • acetyl hexapeptide-8 • caffeine • arginine ferulate • lecithin • cholesterol • yeast extract\faex\extrait de levure • sorbitol • glycerin • trehalose • phytosphingosine • polyquaternium-51 • styrene/acrylates copolymer • cetyl alcohol • vp/eicosene copolymer • polysilicone-11 • sucrose • urea • caprylyl glycol • ethylhexylglycerin • saccharide isomerate • caprylic/capric triglyceride • ammonium acryloyldimethyltaurate/vp copolymer • sodium pca • sodium hyaluronate • dehydroxanthan gum • peg-8 laurate • tocopheryl acetate • citric acid • tourmaline • propyl gallate • xanthan gum • ascorbyl tocopheryl maleate • stearic acid • nordihydroguaiaretic acid • alcohol denat. • fragrance (parfum) • hexylene glycol • disodium edta • sodium dehydroacetate • phenoxyethanol • hydroxycitronellal • linalool • hexyl cinnamal • amyl cinnamal • benzyl benzoate • coumarin • limonene • citronellol • geraniol • citral • mica <iln39596>

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  • Other information

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

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  • SPL UNCLASSIFIED SECTION

    MAX HUBER RESEARCH LABS INC., DIST.
    NEW YORK, N.Y. 10022

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  • PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

    SOLEIL DE LA MER™

    LA MER

    the reparative face sun lotion
    broad spectrum spf 30

    1.7 fl. oz./oz. liq./50 ml e

    Principal Display Panel - 50 mL Carton
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  • INGREDIENTS AND APPEARANCE
    LA MER THE REPARATIVE FACE SUN BROAD SPECTRUM SPF 30 
    avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:65966-011
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.0312 g  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 0.052 g  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.052 g  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 0.02808 g  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0312 g  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    water (UNII: 059QF0KO0R)  
    dimethicone (UNII: 92RU3N3Y1O)  
    butyloctyl salicylate (UNII: 2EH13UN8D3)  
    neopentyl glycol diheptanoate (UNII: 5LKW3C543X)  
    butylene glycol (UNII: 3XUS85K0RA)  
    peg-100 stearate (UNII: YD01N1999R)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    shea butter (UNII: K49155WL9Y)  
    methyl trimethicone (UNII: S73ZQI0GXM)  
    phenyl trimethicone (UNII: DR0K5NOJ4R)  
    trisiloxane (UNII: 9G1ZW13R0G)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    potassium cetyl phosphate (UNII: 03KCY6P7UT)  
    sesame oil (UNII: QX10HYY4QV)  
    alfalfa seed (UNII: 67PHZ58858)  
    helianthus annuus seedcake (UNII: 482WYF7XLC)  
    eucalyptus oil (UNII: 2R04ONI662)  
    sodium gluconate (UNII: R6Q3791S76)  
    copper gluconate (UNII: RV823G6G67)  
    calcium gluconate (UNII: SQE6VB453K)  
    magnesium gluconate (UNII: T42NAD2KHC)  
    zinc gluconate (UNII: U6WSN5SQ1Z)  
    .alpha.-tocopherol succinate, d- (UNII: LU4B53JYVE)  
    niacin (UNII: 2679MF687A)  
    sesame seed (UNII: 7Y1255HVXR)  
    laminaria ochroleuca (UNII: 4R2124HE76)  
    rosemary (UNII: IJ67X351P9)  
    lime peel (UNII: 544EQK5Q0W)  
    cucumber (UNII: YY7C30VXJT)  
    apple (UNII: B423VGH5S9)  
    scutellaria baicalensis root (UNII: 7J95K7ID2S)  
    acetyl hexapeptide-8 (UNII: L4EL31FWIL)  
    caffeine (UNII: 3G6A5W338E)  
    cholesterol (UNII: 97C5T2UQ7J)  
    yeast (UNII: 3NY3SM6B8U)  
    sorbitol (UNII: 506T60A25R)  
    glycerin (UNII: PDC6A3C0OX)  
    trehalose (UNII: B8WCK70T7I)  
    phytosphingosine (UNII: GIN46U9Q2Q)  
    cetyl alcohol (UNII: 936JST6JCN)  
    sucrose (UNII: C151H8M554)  
    urea (UNII: 8W8T17847W)  
    caprylyl glycol (UNII: 00YIU5438U)  
    ethylhexylglycerin (UNII: 147D247K3P)  
    saccharide isomerate (UNII: W8K377W98I)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG)  
    sodium pyrrolidone carboxylate (UNII: 469OTG57A2)  
    hyaluronate sodium (UNII: YSE9PPT4TH)  
    peg-8 laurate (UNII: 762O8IWA10)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    citric acid monohydrate (UNII: 2968PHW8QP)  
    propyl gallate (UNII: 8D4SNN7V92)  
    xanthan gum (UNII: TTV12P4NEE)  
    ascorbyl tocopheryl maleate (UNII: D2G6259XR5)  
    stearic acid (UNII: 4ELV7Z65AP)  
    masoprocol (UNII: 7BO8G1BYQU)  
    hexylene glycol (UNII: KEH0A3F75J)  
    edetate disodium (UNII: 7FLD91C86K)  
    sodium dehydroacetate (UNII: 8W46YN971G)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    hydroxycitronellal (UNII: 8SQ0VA4YUR)  
    .alpha.-hexylcinnamaldehyde (UNII: 7X6O37OK2I)  
    .alpha.-amylcinnamaldehyde (UNII: WC51CA3418)  
    benzyl benzoate (UNII: N863NB338G)  
    coumarin (UNII: A4VZ22K1WT)  
    .beta.-citronellol, (r)- (UNII: P01OUT964K)  
    geraniol (UNII: L837108USY)  
    citral (UNII: T7EU0O9VPP)  
    mica (UNII: V8A1AW0880)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65966-011-01 1 in 1 CARTON
    1 50 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 11/11/2012
    Labeler - MAX HUBER RESEARCH LAB INC (926708694)
    Establishment
    Name Address ID/FEI Business Operations
    ELGC K.K. 712808195 RELABEL(65966-011) , REPACK(65966-011)
    Establishment
    Name Address ID/FEI Business Operations
    Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(65966-011) , RELABEL(65966-011) , REPACK(65966-011)
    Establishment
    Name Address ID/FEI Business Operations
    Estee Lauder Inc. 042918826 MANUFACTURE(65966-011)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 REPACK(65966-011) , RELABEL(65966-011)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD 253616536 MANUFACTURE(65966-011)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(65966-011)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(65966-011)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER N.V. 370151326 MANUFACTURE(65966-011)
    Establishment
    Name Address ID/FEI Business Operations
    LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(65966-011)
    Establishment
    Name Address ID/FEI Business Operations
    NORTEC KEYSTONE 943871157 MANUFACTURE(65966-011) , RELABEL(65966-011) , REPACK(65966-011)
    Establishment
    Name Address ID/FEI Business Operations
    NORTHTEC BRISTOL 959338336 MANUFACTURE(65966-011) , RELABEL(65966-011) , REPACK(65966-011)
    Establishment
    Name Address ID/FEI Business Operations
    NORTHTEC KEYSTONE 949264774 MANUFACTURE(65966-011) , RELABEL(65966-011) , REPACK(65966-011)
    Establishment
    Name Address ID/FEI Business Operations
    WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(65966-011)
    Establishment
    Name Address ID/FEI Business Operations
    Aveda Corporation 071352058 MANUFACTURE(65966-011)
    Establishment
    Name Address ID/FEI Business Operations
    Pennsylvania Logistics Center 078364654 REPACK(65966-011) , RELABEL(65966-011)
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