Label: FOREVER YOUNG BODY BUTTER BROAD SPECTRUM SUNSCREEN SPF 40 SUPERGOOP- avobenzone, homosalate, octinoxate, octisalate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 November 12, 2020

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

  • ACTIVE INGREDIENT

    Active Ingredient ................. Purpose

    Avobenzone 3 % ................ Sunscreen

    Homosalat 7.5 %................ Sunscreen

    Otinoxate 7.5% ................ Sunscreen

    Octisalate 5% ................ Sunscreen

  • PURPOSE

    Uses

    Helps prevent sunburn

    If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs

  • WARNINGS

    For external use only

    Do not use on damaged or broken skin

    When using this prodcut keep out of eyes

    Rinse with water to remove

    If swallowed, get medical help or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Directions

    Apply Liberally to body at least 15 minutes prior to sune exposure

    Use a water resistant sunscreen if swimming or sweating

    Reapply at least every 2 hours

    Children under 6 months: Ask a doctor

    Sun Protection Measures

    Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and take other sun protection measures including:

    Limit time in the sun, especially from 10 a.m. - 2 p.m.

    Wear long-sleeved shirts, pants, hates, and sunglasses

  • INACTIVE INGREDIENT

    Water, Isononyl Isononanoate, Caprylyl Methicone, Dicaprylyl Ether, Polyester-8, Demthicone, Glycerin, Propanediol, Cetearyl Alcohol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sorbitan Stearate, Phenoxyethanol, Pyrus Mallus (Apple) Fruit Extract, Potassium Cetyl Phosphate, Ceteareth-20, Sodium Polyactylate, Starch, Diethylhexyl Syringylidenemalonate, Sodium PCA, Hydrogenated Palm Glycerides, Ethylhexyglycerin, Chlorphenesin, Sodium Ascorbyl Glucoside, Butylene Glycol, Disodium EDTA, Trimethylcyclohexyl Butylcarbamate, Xanthan Gum, Citrus Tangerina (Tangerine) Peel Oil, Cymbopogon Shoenanthus Oil, Elettaria Cardamomum Seed Oil, Eucalyptus Globulus Leaf Oil, Eugenia Caryophylus (Clove) Flower Oil, Lavandula Hyrvida Oil, Vanilli, Limonene, Polygonum Aviculare Extract, BHT, Citral, Hippophae Rhamnoides Fruit Extract, Maltodextrin, Portulaca Oleracea Extract, Potassium Sorbate, Sodium Benzoate, Tocopherol.  

  • PRINCIPAL DISPLAY PANEL

    Forever Young

    Body Butter

    With Sea Buckthorn

    Broad Spectrum Sunscreen SPF 40

    5.7 fl. oz. /168 ml.

    Tube

  • INGREDIENTS AND APPEARANCE
    FOREVER YOUNG BODY BUTTER BROAD SPECTRUM SUNSCREEN SPF 40   SUPERGOOP
    avobenzone, homosalate, octinoxate, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-139
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7.5 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    APPLE (UNII: B423VGH5S9)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MANDARIN OIL (UNII: NJO720F72R)  
    CYMBOPOGON SCHOENANTHUS OIL (UNII: XE7K568ILO)  
    CARDAMOM OIL (UNII: JM0KJ091HZ)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    CLOVE OIL (UNII: 578389D6D0)  
    LAVANDIN OIL (UNII: 9RES347CKG)  
    VANILLA (UNII: Q74T35078H)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    PURSLANE (UNII: M6S840WXG5)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-139-021 in 1 BOX05/13/2015
    1NDC:75936-139-01168 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:75936-139-0371 mL in 1 TUBE; Type 0: Not a Combination Product07/19/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35205/13/2015
    Labeler - Taylor James Ltd (033381850)
    Registrant - Taylor James Ltd (033381850)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosway Company Inc052400223manufacture(75936-139)