Label: SUPERDEFENSE BROAD SPECTRUM SPF 25 FATIGUE PLUS 1ST SIGNS OF AGE MULTI-CORRECTING VERY DRY TO DRY COMBINATION- avobenzone, homosalate, and octisalate cream

  • NDC Code(s): 49527-077-01
  • Packager: CLINIQUE LABORATORIES LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 19, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Avobenzone 3.0%
    Homosalate 5.0%
    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 • butyloctyl salicylate • dimethicone • polyester-8 • cetearyl alcohol • glyceryl stearate • peg-100 stearate • shea butter ethyl esters • butylene glycol • petrolatum • styrene/acrylates copolymer • glycerin • niacinamide • trehalose • vp/eicosene copolymer • daucus carota sative (carrot) root extract • brassica oleracea gemmifera (brussels sprouts) extract • vaccinium macrocarpon (cranberry) fruit extract • resveratrol • brassica oleracea italica (broccoli) extract • acetyl carnitine hcl • vaccinium angustifolium (blueberry) fruit extract • salicylic acid • brassica oleracea acephala (kale) leaf extract • creatine • spinacia oleracea (spinach) leaf extract • cucumis sativus (cucumber) fruit extract • lactobacillus ferment • adenosine phosphate • hordeum vulgare (barley) extract\extrait d'orge • sigesbeckia orientalis (st. paul's wort) extract • albizia julibrissin bark extract • arabidopsis thaliana extract • plankton extract • isohexadecane • oryza sativa (rice) bran extract • potassium cetyl phosphate • tocopheryl acetate • caffeine • ethylhexylglycerin • algae extract • micrococcus lysate • ergothioneine • sodium hyaluronate • 7-dehydrocholesterol • caprylyl glycol • biosaccharide gum-4 • hydrogenated palm glycerides • acrylates/c10-30 alkyl acrylate crosspolymer • propylene glycol dicaprate • peg-8 laurate • helianthus annuus (sunflower) seedcake • polyethylene • yeast extract\faex\extrait de levure • tromethamine • dimethiconol • sodium rna • polysorbate 80 • lecithin • sea whip extract • xanthan gum • acrylamide/sodium acryloyldimethyltaurate copolymer • tetrahexyldecyl ascorbate • propylene glycol caprylate • phytic acid • disodium edta • bht • phenoxyethanol • mica • titanium dioxide (ci 77891) [iln44658]

  • Other information

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

  • PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

    de-aging

    CLINIQUE

    superdefense
    broad spectrum SPF 25

    fatigue + 1 st signs of age
    multi-correcting cream

    VERY DRY TO DRY COMBINATION

    NET WT. 1.7 OZ./50 ml e

    PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton
  • INGREDIENTS AND APPEARANCE
    SUPERDEFENSE BROAD SPECTRUM SPF 25 FATIGUE PLUS 1ST SIGNS OF AGE MULTI-CORRECTING VERY DRY TO DRY COMBINATION 
    avobenzone, homosalate, and octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-077
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE50 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    RICE BRAN (UNII: R60QEP13IC)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CAFFEINE (UNII: 3G6A5W338E)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ERGOTHIONEINE (UNII: BDZ3DQM98W)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    TREHALOSE (UNII: B8WCK70T7I)  
    CARROT (UNII: L56Z1JK48B)  
    BRUSSELS SPROUT (UNII: KHX46H31F8)  
    CRANBERRY (UNII: 0MVO31Q3QS)  
    RESVERATROL (UNII: Q369O8926L)  
    BROCCOLI (UNII: UOI4FT57BZ)  
    LEVACECARNINE HYDROCHLORIDE (UNII: NDW10MX58T)  
    LOWBUSH BLUEBERRY (UNII: G90PX41VP0)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    KALE (UNII: 0Y3L4J38H1)  
    CREATINE (UNII: MU72812GK0)  
    SPINACH (UNII: 6WO75C6WVB)  
    CUCUMBER (UNII: YY7C30VXJT)  
    ADENOSINE PHOSPHATE (UNII: 415SHH325A)  
    BARLEY (UNII: 5PWM7YLI7R)  
    ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)  
    ARABIDOPSIS THALIANA WHOLE (UNII: AI3L60HQ81)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY)  
    PEG-8 LAURATE (UNII: 762O8IWA10)  
    HELIANTHUS ANNUUS SEEDCAKE (UNII: 482WYF7XLC)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    PROPYLENE GLYCOL MONOCAPRYLATE (UNII: RT9P9S09QI)  
    FYTIC ACID (UNII: 7IGF0S7R8I)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49527-077-011 in 1 CARTON01/28/2020
    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 DrugM02001/28/2020
    Labeler - CLINIQUE LABORATORIES LLC (044475127)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Estee Lauder Inc802599436manufacture(49527-077) , pack(49527-077) , label(49527-077)