Label: CLINIQUE FOR MEN BROAD SPECTRUM SPF 21 MOISTURIZER- avobenzone, octinoxate, octisalate, and oxybenzone lotion

  • NDC Code(s): 49527-081-01
  • Packager: CLINIQUE LABORATORIES LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 20, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Avobenzone 3.0%
    Octinoxate 7.4%
    Octisalate 5.0%
    Oxybenzone 2.0%

  • 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•butylene glycol•dimethicone•neopentyl glycol diheptanoate•cetearyl alcohol•peg-100 stearate•silica•hordeum vulgare (barley) extract\extrait d'orge•algae extract•cucumis sativus (cucumber) fruit extract•helianthus annuus (sunflower) seedcake•cholesterol•cetearyl glucoside•propylene glycol dicaprate•tridecyl trimellitate•hydrogenated lecithin•stearyl alcohol•zeolite•lactobacillus ferment•cetrimonium chloride•tridecyl stearate•isododecane•dipentaerythrityl hexacaprylate/hexacaprate•pvp•oleth-10•laureth-4•laureth-23•caprylyl glycol•hexylene glycol•polyethylene•tromethamine•carbomer•sodium citrate•disodium edta•potassium sorbate•phenoxyethanol•yellow 5 (ci 19140)•yellow 6 (ci 15985)•red 33 (ci 17200) [iln43259]

  • Other information

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

  • PRINCIPAL DISPLAY PANEL - 100 mL Tube Label

    CLINIQUE
    FOR MEN

    broad
    spectrum
    SPF 21
    moisturizer

    3.4 FL.OZ.LIQ./100 ml ℮

    PRINCIPAL DISPLAY PANEL - 100 mL Tube Label
  • INGREDIENTS AND APPEARANCE
    CLINIQUE FOR MEN BROAD SPECTRUM SPF 21 MOISTURIZER 
    avobenzone, octinoxate, octisalate, and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-081
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE74 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    AGAR, UNSPECIFIED (UNII: 89T13OHQ2B)  
    ZEOLITE A (UNII: Y3NG9WF08W)  
    LIMOSILACTOBACILLUS REUTERI (UNII: 9913I24QEE)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    SILICA, TRIMETHYLSILYL CAPPED (UNII: VU10KU4B9S)  
    BARLEY (UNII: 5PWM7YLI7R)  
    CUCUMBER (UNII: YY7C30VXJT)  
    HELIANTHUS ANNUUS SEEDCAKE (UNII: 482WYF7XLC)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    ISODODECANE (UNII: A8289P68Y2)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    OLETH-10 (UNII: JD797EF70J)  
    LAURETH-4 (UNII: 6HQ855798J)  
    LAURETH-23 (UNII: N72LMW566G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49527-081-011 in 1 CARTON07/21/2021
    1100 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02007/21/2021
    Labeler - CLINIQUE LABORATORIES LLC (044475127)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Estee Lauder Inc802599436manufacture(49527-081) , pack(49527-081) , label(49527-081)
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