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

  • NDC Code(s): 49527-050-01
  • 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•butyloctyl salicylate•glycerin•polyester-8• polysorbate 60•cetyl alcohol•butylene glycol•sorbitan stearate•dimethicone•tridecyl stearate•peg-100 stearate• saccharomyces/xylinum/black tea ferment•sodium hyaluro-nate•astrocaryum murumuru seed butter•tridecyl trimellitate• dipentaerythrityl hexacaprylate/hexacaprate•algae extract• plankton extract•laminaria saccharina extract•whey protein\lactis protein\protéine du petit-lait•sigesbeckia orientalis (st. paul's wort) extract•acetyl glucosamine•glycine soja (soybean) protein•centaurium erythraea (centaury) extract•styrene/acrylates copolymer•cetyl palmitate•acrylates/c10-30 alkyl acrylate crosspolymer•polyethylene•acetyl hexapeptide-8•biotin• aminopropyl ascorbyl phosphate•sorbitan palmitate•sorbitan olivate•ethylhexylglycerin•caffeine•tocopheryl acetate•sodium polyacrylate•trehalose•peg-8 laurate•ergothioneine•lecithin• calcium chloride•hydroxyethylcellulose•sodium benzoate• tocopherol•citric acid•sodium hydroxide•pentylene glycol•sodium citrate•disodium edta•potassium sorbate•phenoxyethanol•chlorphenesin• yellow 5 (ci 19140)•red 4 (ci 14700) [iln48788]

  • 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

    COMBINATION OILY TO OILY

    NET WT. 1.7 OZ./50 ml e

    PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton
  • INGREDIENTS AND APPEARANCE
    CLINIQUE SMART CUSTOM REPAIR MOISTURIZER BROAD SPECTRUM SPF 15 - COMBINATION/OILY TO OILY 
    avobenzone and octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-050
    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
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    AGAR, UNSPECIFIED (UNII: 89T13OHQ2B)  
    TAMARIND SEED (UNII: 6AHP8A7OML)  
    N-ACETYLGLUCOSAMINE (UNII: V956696549)  
    SOY PROTEIN (UNII: R44IWB3RN5)  
    CENTAURIUM ERYTHRAEA (UNII: 57X4TSH58S)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
    BIOTIN (UNII: 6SO6U10H04)  
    AMINOPROPYL ASCORBYL PHOSPHATE (UNII: 290O2PQ83R)  
    SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CAFFEINE (UNII: 3G6A5W338E)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ERGOTHIONEINE (UNII: BDZ3DQM98W)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    PEG-8 LAURATE (UNII: 762O8IWA10)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    SIGESBECKIA ORIENTALIS FLOWERING TOP (UNII: 6UL878YAR7)  
    WHEY (UNII: 8617Z5FMF6)  
    SACCHARINA LATISSIMA (UNII: 68CMP2MB55)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49527-050-011 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(49527-050)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Ltd.204132062pack(49527-050) , label(49527-050)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Estee Lauder Inc802599436manufacture(49527-050) , pack(49527-050) , label(49527-050)