Label: LA MER THE BROAD SPECTRUM SPF 50 UV PROTECTING FLUID- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

  • NDC Code(s): 65966-016-01
  • 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 17, 2018

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • Active ingredients

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

    Close
  • Purpose

    Sunscreen

    Close
  • 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
    Close
  • 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.

    Close
  • 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
    Close
  • 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>

    Close
  • Other information

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

    Close
  • 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
    Close
  • 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 05/05/2013
    1 50 mL in 1 BOTTLE; 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 05/05/2013
    Labeler - MAX HUBER RESEARCH LAB INC (926708694)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COMPANY, THE 828534516 RELABEL(65966-016) , REPACK(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. 202952982 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
    NORTHTEC INC 943871157 RELABEL(65966-016) , REPACK(65966-016)
    Establishment
    Name Address ID/FEI Business Operations
    PADC 1 949264774 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
    ESTEE LAUDER COSMETICS, LTD 255175580 MANUFACTURE(65966-016)
    Close