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LA MER THE BROAD SPECTRUM SPF 50 UV PROTECTING FLUID (MAX HUBER RESEARCH LAB INC)

Available Formats

Dosage Form Package Information Links
LOTION 1 BOTTLE in 1 CARTON (65966-016-01) > 50 mL in 1 BOTTLE Label Information

Complete LA MER THE BROAD SPECTRUM SPF 50 UV PROTECTING FLUID Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredients

    AVOBENZONE 3.00%
    HOMOSALATE 5.00%
    OCTISALATE 5.00%
    OCTOCRYLENE 2.70%
    OXYBENZONE 3.00%


  • Purpose

    Sunscreen


  • 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

  • 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 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

  • Ingredients

    WATER\AQUA\EAU BUTYLOCTYL SALICYLATE METHYL TRIMETHICONE NEOPENTYL GLYCOL DIHEPTANOATE ALEURITES MOLUCCANA (KUKUI) SEED OIL LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE PEG 100 STEARATE BUTYLENE GLYCOL GLYCERYL STEARATE DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE 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 MALACHITE CAFFEINE SORBITOL SODIUM HYALURONATE CETYL ALCOHOL STEARIC ACID VP/EICOSENE COPOLYMER ETHYLHEXYLGLYCERIN SACCHARIDE ISOMERATE CAPRYLIC/CAPRIC TRIGLYCERIDE CAPRYLYL GLYCOL AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER DEHYDROXANTHAN GUM SODIUM DEHYDROACETATE CITRIC ACID TOURMALINE STYRENE/ACRYLATES COPOLYMER SILICA PEG-8 LAURATE FRAGRANCE (PARFUM) DISODIUM EDTA PHENOXYETHANOL LIMONENE GERANIOL HYDROXYCITRONELLAL LINALOOL CITRONELLOL MICA GREEN 5 (CI 61570) TITANIUM DIOXIDE (CI 77891) <ILN40137>


  • Other information

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


  • PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton

    LA MER

    the broad spectrum
    spf 50 UV protecting fluid

    1.7 fl. oz. liq./50 ml e

    Principal Display Panel - 50 ml Bottle Carton

  • INGREDIENTS AND APPEARANCE
    LA MER THE BROAD SPECTRUM SPF 50 UV PROTECTING FLUID 
    avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:65966-016
    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)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    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)  
    CAFFEINE (UNII: 3G6A5W338E)  
    SORBITOL (UNII: 506T60A25R)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PEG-8 LAURATE (UNII: 762O8IWA10)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GERANIOL (UNII: L837108USY)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    MICA (UNII: V8A1AW0880)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65966-016-01 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 05/05/2013
    Labeler - MAX HUBER RESEARCH LAB INC (926708694)
    Establishment
    Name Address ID/FEI Business Operations
    ELGC K.K. 712808195 RELABEL(65966-016) , REPACK(65966-016)
    Establishment
    Name Address ID/FEI Business Operations
    Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(65966-016) , RELABEL(65966-016) , REPACK(65966-016)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 REPACK(65966-016) , RELABEL(65966-016)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(65966-016)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(65966-016)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER N.V. 370151326 MANUFACTURE(65966-016)
    Establishment
    Name Address ID/FEI Business Operations
    LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(65966-016)
    Establishment
    Name Address ID/FEI Business Operations
    NORTEC KEYSTONE 943871157 MANUFACTURE(65966-016) , RELABEL(65966-016) , REPACK(65966-016)
    Establishment
    Name Address ID/FEI Business Operations
    NORTHTEC BRISTOL 959338336 MANUFACTURE(65966-016) , RELABEL(65966-016) , REPACK(65966-016)
    Establishment
    Name Address ID/FEI Business Operations
    NORTHTEC KEYSTONE 949264774 MANUFACTURE(65966-016) , RELABEL(65966-016) , REPACK(65966-016)
    Establishment
    Name Address ID/FEI Business Operations
    WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(65966-016)
    Establishment
    Name Address ID/FEI Business Operations
    Aveda Corporation 071352058 MANUFACTURE(65966-016)
    Establishment
    Name Address ID/FEI Business Operations
    Pennsylvania Logistics Center 078364654 REPACK(65966-016) , RELABEL(65966-016)