Label: CLINIQUE SMART BROAD SPECTRUM SPF 15 CUSTOM-REPAIR MOISTURIZER DRY COMBINATION- avobenzone and octisalate cream

  • NDC Code(s): 49527-051-01, 49527-051-02, 49527-051-03, 49527-051-04, view more
    49527-051-05
  • Packager: CLINIQUE LABORATORIES LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 21, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Avobenzone 3.0%
    Octisalate 5.0%

  • 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 • glycerin • butyloctyl salicylate • polyester-8 • octyldodecyl neopentanoate • behenyl alcohol • butylene glycol • myristyl myristate • cetyl esters • ammonium acryloyldimethyltaurate/vp copolymer • plankton extract • centaurium erythraea (centaury) extract • sigesbeckia orientalis (st. paul's wort) extract • glyceryl stearate • algae extract • caffeine • whey protein\lactis protein\protéine du petit-lait • nylon-12 • acetyl hexapeptide-8 • sucrose • biotin • ergothioneine • myristyl laurate • lauryl peg-9 polydimethylsiloxyethyl dimethicone • polyethylene • aminopropyl ascorbyl phosphate • glycine soja (soybean) protein • peg-100 stearate • steareth-21 • saccharomyces/xylinum/black tea ferment • dimethicone • acetyl glucosamine • astrocaryum murumuru seed butter • trisiloxane • caprylyl glycol • tocopheryl acetate • myristyl alcohol • sodium hyaluronate • hexylene glycol • calcium chloride • hydroxyethylcellulose • sodium benzoate • citric acid • sodium citrate • lecithin • disodium edta • potassium sorbate • phenoxyethanol • yellow 5 (ci 19140) • red 4 (ci 14700) [iln49049]

  • Other information

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

  • PRINCIPAL DISPLAY PANEL - 75 ml Jar Carton

    de-aging

    CLINIQUE
    clinique smart
    broad spectrum SPF 15
    custom-repair moisturizer

    DRY COMBINATION
    POIDS NET WT. 2.5 OZ./75 ml ℮

    PRINCIPAL DISPLAY PANEL - 75 ml Jar Carton
  • INGREDIENTS AND APPEARANCE
    CLINIQUE SMART BROAD SPECTRUM SPF 15 CUSTOM-REPAIR MOISTURIZER DRY COMBINATION 
    avobenzone and octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-051
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    BLUEFISH (UNII: 79U8P8X3Q5)  
    CENTAURIUM ERYTHRAEA (UNII: 57X4TSH58S)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CAFFEINE (UNII: 3G6A5W338E)  
    NYLON-12 (UNII: 446U8J075B)  
    ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
    SUCROSE (UNII: C151H8M554)  
    BIOTIN (UNII: 6SO6U10H04)  
    ERGOTHIONEINE (UNII: BDZ3DQM98W)  
    MYRISTYL LAURATE (UNII: 58U0NZN2BT)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    AMINOPROPYL ASCORBYL PHOSPHATE (UNII: 290O2PQ83R)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    STEARETH-21 (UNII: 53J3F32P58)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    N-ACETYLGLUCOSAMINE (UNII: V956696549)  
    ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MYRISTYL ALCOHOL (UNII: V42034O9PU)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    SIGESBECKIA ORIENTALIS WHOLE (UNII: ZM9Q0FEI4Z)  
    AGAR, UNSPECIFIED (UNII: 89T13OHQ2B)  
    WHEY PROTEIN HYDROLYSATE (UNII: 237DZG2JLA)  
    SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49527-051-011 in 1 CARTON10/01/2015
    150 mL in 1 JAR; Type 0: Not a Combination Product
    2NDC:49527-051-021 in 1 CARTON07/12/2022
    275 mL in 1 JAR; Type 0: Not a Combination Product
    3NDC:49527-051-031 in 1 CARTON07/12/2022
    315 mL in 1 JAR; Type 0: Not a Combination Product
    4NDC:49527-051-047 mL in 1 PACKET; Type 0: Not a Combination Product07/12/202210/05/2023
    5NDC:49527-051-051 in 1 CARTON10/01/2015
    57 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/01/2015
    Labeler - CLINIQUE LABORATORIES LLC (044475127)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Ltd.202952982manufacture(49527-051)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Ltd.204132062pack(49527-051) , label(49527-051)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Estee Lauder Inc802599436manufacture(49527-051) , pack(49527-051) , label(49527-051)
    Establishment
    NameAddressID/FEIBusiness Operations
    Northtec LLC943871157pack(49527-051) , label(49527-051)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC KEYSTONE949264774pack(49527-051) , label(49527-051)
    Establishment
    NameAddressID/FEIBusiness Operations
    PALC078364654pack(49527-051) , label(49527-051)
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