Label: CLINIQUE- octisalate, homosalate, oxybenzone, avobenzone, and octocrylene cream

  • 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 October 15, 2011

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  • TO USE

    Apply liberally before sun exposure and as needed. Children under 6 months of age: ask a doctor. Reapply frequently, and after towel drying, swimming or perspiring.

  • WARNING

    For external use only. Keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if rash or irritation develops and lasts.

    Keep out of reach of children. If swallowed, get medical help right away.

  • ACTIVE INGREDIENTS

    OCTISALATE 5.0% • HOMOSALATE 5.0% • OXYBENZONE 4.0% • AVOBENZONE 3.0% • OCTOCRYLENE 2.7%.

  • INGREDIENTS

    WATER • METHYL TRIMETHICONE • BUTYLENE GLYCOL • BUTYLOCTYL SALICYLATE • NEOPENTYL GLYCOL DIHEPTANOATE • BUTYROSPERMUM PARKII (SHEA BUTTER) • PEG-100 STEARATE • SILICA • DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE • LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE • DIMETHICONE • GLYCERYL STEARATE • LAURDIMONIUM HYDROXYPROPYL HYDROLYZED SOY PROTEIN • ROSMARINUS OFFICINALIS (ROSEMARY) EXTRACT • PERILLA OCYMOIDES LEAF EXTRACT • PLANKTON EXTRACT • CAFFEINE • POTASSIUM CETYL PHOSPHATE • SUCROSE • STYRENE/ACRYLATES COPOLYMER • C30-38 OLEFIN/ISOPROPYL MALEATE/MA COPOLYMER • CETYL ALCOHOL • VP/EICOSENE COPOLYMER • ETHYLHEXYLGLYCERIN • AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER • PEG-8 LAURATE • SODIUM RNA • PHOSPHOLIPIDS • LECITHIN • C1-8 ALKYL TETRAHYDROXYCYCLOHEXANOATE • HYDROXYETHYLCELLULOSE • TOCOPHERYL ACETATE • CAPRYLYL GLYCOL • ASCORBYL TOCOPHERYL MALEATE • STEARIC ACID • XANTHAN GUM • MALTODEXTRIN • FERULIC ACID • HEXYLENE GLYCOL • NORDIHYDROGUAIARETIC ACID • DISODIUM EDTA • PHENOXYETHANOL • MICA • SODIUM DEHYDROACETATE [ILN35074]

  • SPL UNCLASSIFIED SECTION

    CLINIQUE LABS., DIST.
    NEW YORK, N.Y. 10022

  • PRINCIPAL DISPLAY PANEL - 50 ml Carton

    CLINIQUE

    SPF
    30
    with
    SolarSmart

    UVA UVB
    advanced
    protection

    face cream

    1.7 FL. OZ.
    50 ml e

    Principal Display Panel - 50 ml Carton
  • INGREDIENTS AND APPEARANCE
    CLINIQUE   SPF 30 WITH SOLAR SMART
    octisalate, homosalate, oxybenzone, avobenzone, and octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-716
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    octisalate (UNII: 4X49Y0596W) (octisalate - UNII:4X49Y0596W) octisalate5 mL  in 100 mL
    homosalate (UNII: V06SV4M95S) (homosalate - UNII:V06SV4M95S) homosalate5 mL  in 100 mL
    oxybenzone (UNII: 95OOS7VE0Y) (oxybenzone - UNII:95OOS7VE0Y) oxybenzone4 mL  in 100 mL
    avobenzone (UNII: G63QQF2NOX) (avobenzone - UNII:G63QQF2NOX) avobenzone3 mL  in 100 mL
    octocrylene (UNII: 5A68WGF6WM) (octocrylene - UNII:5A68WGF6WM) octocrylene2.7 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    methyl trimethicone (UNII: S73ZQI0GXM)  
    butylene glycol (UNII: 3XUS85K0RA)  
    butyloctyl salicylate (UNII: 2EH13UN8D3)  
    neopentyl glycol diheptanoate (UNII: 5LKW3C543X)  
    shea butter (UNII: K49155WL9Y)  
    peg-100 stearate (UNII: YD01N1999R)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    dimethicone (UNII: 92RU3N3Y1O)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    rosemary (UNII: IJ67X351P9)  
    perilla frutescens leaf (UNII: T4L5881Y68)  
    caffeine (UNII: 3G6A5W338E)  
    potassium cetyl phosphate (UNII: 03KCY6P7UT)  
    sucrose (UNII: C151H8M554)  
    cetyl alcohol (UNII: 936JST6JCN)  
    ethylhexylglycerin (UNII: 147D247K3P)  
    peg-8 laurate (UNII: 762O8IWA10)  
    alpha-tocopherol acetate (UNII: 9E8X80D2L0)  
    caprylyl glycol (UNII: 00YIU5438U)  
    stearic acid (UNII: 4ELV7Z65AP)  
    xanthan gum (UNII: TTV12P4NEE)  
    maltodextrin (UNII: 7CVR7L4A2D)  
    ferulic acid (UNII: AVM951ZWST)  
    hexylene glycol (UNII: KEH0A3F75J)  
    masoprocol (UNII: 7BO8G1BYQU)  
    edetate disodium (UNII: 7FLD91C86K)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    mica (UNII: V8A1AW0880)  
    sodium dehydroacetate (UNII: 8W46YN971G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49527-716-011 in 1 CARTON
    150 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35209/01/2010
    Labeler - CLINIQUE LABORATORIES INC. (173047747)
    Establishment
    NameAddressID/FEIBusiness Operations
    ELGC Kabushiki Kaisha712808195RELABEL, REPACK
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE, RELABEL, REPACK
    Establishment
    NameAddressID/FEIBusiness Operations
    ARAMIS, INC042918826MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK, RELABEL
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD255175580MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER N.V.370151326MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTEC KEYSTONE787336577MANUFACTURE, RELABEL, REPACK
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC BRISTOL949264774MANUFACTURE, RELABEL, REPACK
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC KEYSTONE618107429MANUFACTURE, RELABEL, REPACK
    Establishment
    NameAddressID/FEIBusiness Operations
    WHITMAN LABORATORIES, LTD.216866277MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Aveda Corporation071352058MANUFACTURE
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