Label: FOREVER YOUNG HAND BROAD SPECTRUM SPF 40 SUPERGOOP- avobenzone, homosalate, octinoxate, octocrylene 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

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  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Avobenzone 3% Sunscreen

    Homosalate 10% Sunscreen

    Octinoxate 7% Sunscreen

    Octocrylene 5% Sunscreen

  • PURPOSE

    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

    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

    If swallowed, get medical help or contact a poison control center right away

  • DOSAGE & ADMINISTRATION

    Directions Apply liberally at least 15 minutes prior to exposure to sun or UV lights

    The perfect protection to keep in your purse or wherever your hands may be exposed to photoaging rays

    Reapply at least every 2 hours

    Use a water-resistant sunscreen if swimming or sweating

    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 this 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, hats, and sunglasses

  • INACTIVE INGREDIENT

    Argania Spinosa Kernel Oil, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetyl Esters Chlorphenesin, Citral, Citrus Tangerina (Tangerine) Peel Oil, Cymbopogon Schoenanthus Oil, Diisopropyl Sebacate, Elettraria Cardamamomum Seed Oil, Eucalyptus Globulus Leaf Oil, Eugenia Caryophyllus (Clove) Flower Oil, Glycerin, Glyceryl Stearate, Glucose, Glucose Oxidase, Isodecyl Neopenatoate, Isododecane, Isolates, Lactoperoxidase, Lauryl Lactate, Lavandula Hybrida Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Limonene, Magnesium Sulfate, Nylon-12, PEG-100 Stearate, Plantago Lanceolata Leaf Extract, Propanediol, Raphanus Sativus (Radish) Seed Oil, Sodium Hydroxide, Vanillin Natural, Water, Xanthan Gum.

  • PRINCIPAL DISPLAY PANEL

    Forever young Hand Cream

    With Sea Buckthorn

    Broad Spectrum Sunscreen SPF 40 PA+++

    Supergoop

    1 fl. oz./30 mL

    Secondary

    Primary

  • INGREDIENTS AND APPEARANCE
    FOREVER YOUNG HAND BROAD SPECTRUM SPF 40   SUPERGOOP
    avobenzone, homosalate, octinoxate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-128
    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) HOMOSALATE10 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ARGAN OIL (UNII: 4V59G5UW9X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CITRAL (UNII: T7EU0O9VPP)  
    MANDARIN OIL (UNII: NJO720F72R)  
    CYMBOPOGON SCHOENANTHUS OIL (UNII: XE7K568ILO)  
    DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
    CARDAMOM OIL (UNII: JM0KJ091HZ)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    CLOVE OIL (UNII: 578389D6D0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    GLUCOSE OXIDASE (UNII: 0T8392U5N1)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    ISODODECANE (UNII: A8289P68Y2)  
    LACTOPEROXIDASE BOVINE (UNII: 01UIN5OC49)  
    LAURYL LACTATE (UNII: G5SU0BFK7O)  
    LAVANDIN OIL (UNII: 9RES347CKG)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    NYLON-12 (UNII: 446U8J075B)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PLANTAGO LANCEOLATA LEAF (UNII: 2YWL9J7EE8)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-128-021 in 1 BOX01/20/2014
    1NDC:75936-128-014 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:75936-128-07200 mL in 1 PACKAGE; Type 0: Not a Combination Product10/04/2018
    3NDC:75936-128-041 in 1 BOX01/20/2014
    3NDC:75936-128-0330 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:75936-128-061 in 1 BOX01/20/2014
    4NDC:75936-128-05300 mL in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:75936-128-08200 mL in 1 TUBE; Type 0: Not a Combination Product12/14/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/20/2014
    Labeler - TAYLOR JAMES, LTD. (033381850)
    Registrant - TAYLOR JAMES, LTD. (033381850)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosway Company Inc.052400223manufacture(75936-128)
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