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

  • NDC Code(s): 49527-048-01
  • Packager: CLINIQUE LABORATORIES LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 5, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Avobenzone 3%
    Octisalate 5%

  • 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 • butyrospermum parkii (shea butter) • polyester-8 • cetearyl alcohol • butylene glycol • glyceryl stearate • peg-100 stearate • sucrose polystearate • cetyl alcohol • dimethicone • theobroma grandiflorum seed butter • polyethylene • nylon-12 • astrocaryum murumuru seed butter • camellia sinensis leaf extract • biotin • sigesbeckia orientalis (st. paul's wort) extract • centaurium erythraea (centaury) extract • algae extract • tamarindus indica seed extract • whey protein\lactis protein\protéine du petit-lait • glycine soja (soybean) protein • ergothioneine • acetyl hexapeptide-8 • saccharomyces ferment filtrate • plankton extract • hydrogenated polyisobutene • acetyl glucosamine • caffeine • aminopropyl ascorbyl phosphate • caprylyl glycol • tocopheryl acetate • lecithin • sodium hyaluronate • ammonium acryloyldimethyltaurate/vp copolymer • pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate • polysilicone-11 • potassium sorbate • sodium benzoate • hydroxyethylcellulose • citric acid • xanthan gum • sodium citrate • phenoxyethanol • yellow 5 (ci 19140) • red 4 (ci 14700) [iln41876]

  • Other information

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

  • PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

    de-aging

    CLINIQUE

    clinique smart

    broad spectrum SPF 15

    custom-repair moisturizer

    VERY DRY TO DRY

    POIDS NET WT. 1.7 OZ./50 ml e

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    CLINIQUE SMART CUSTOM REPAIR MOISTURIZER BROAD SPECTRUM SPF 15 - VERY DRY/DRY 
    avobenzone and octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-048
    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
    WHEY (UNII: 8617Z5FMF6)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    DICTYOPTERIS POLYPODIOIDES (UNII: 83H6O5GR42)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SIGESBECKIA ORIENTALIS WHOLE (UNII: ZM9Q0FEI4Z)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    SUCROSE TETRASTEARATE TRIACETATE (UNII: 1K7LBQ045N)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    NYLON-12 (UNII: 446U8J075B)  
    ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    BIOTIN (UNII: 6SO6U10H04)  
    CENTAURIUM ERYTHRAEA (UNII: 57X4TSH58S)  
    TAMARIND SEED (UNII: 6AHP8A7OML)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    ERGOTHIONEINE (UNII: BDZ3DQM98W)  
    ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
    N-ACETYLGLUCOSAMINE (UNII: V956696549)  
    CAFFEINE (UNII: 3G6A5W338E)  
    AMINOPROPYL ASCORBYL PHOSPHATE (UNII: 290O2PQ83R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49527-048-011 in 1 CARTON12/01/2015
    150 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/01/2015
    Labeler - CLINIQUE LABORATORIES LLC (044475127)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Ltd.202952982manufacture(49527-048)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Ltd.204132062pack(49527-048) , label(49527-048)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Estee Lauder Inc802599436manufacture(49527-048) , pack(49527-048) , label(49527-048)