Label: SUN-DEFYING SUNSCREEN OIL BROAD SPECTRUM SPF 50 SUPERGOOP- avobenzone, homosalate, octisalate, octocrylene, octinoxate oil

  • 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 15% Sunscreen

    Octisalate 5% Sunscreen

    Octocrylene 7% Sunscreen

    Octinoxate 7.5 % 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

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

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions
    · Apply liberally 15 minutes before sun 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 this risk, regularly use a sunscreen
    with broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses

  • INACTIVE INGREDIENT

    Octyl Dodecanol, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, SD Alcohol 40-B, Ethylenediamine/Hydrogenated Dimer Dilinoleate Copolymer Bis-Di-C14-18 Alkyl Amide, Isodecyl Neopentanoate, Diisopropyl Sebacate, Lauryl Lactate, Alaria Esculenta Extract, Limnanthes Alba (Meadowfoam) Seed Oil, Raphanus Sativus (Radish) Seed Oil, Vitis Vinifera (Grape) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Tocotrienol, Argania Spinosa Kernel Oil, Cocos Nucifera (Coconut) Oil, Butyrospermum Parkii (Shea) Butter, Punica Granatum Fruit Extract, Citrus Grandis (Grapefruit) Peel Extract, Citrus Aurantium Dulcis (Orange) Peel Extract, Citrus Tangerina (Tangerine) Peel Extract, Citrus Limon (Lemon) Peel Extract, Calendula Officinalis Flower Extract

  • PRINCIPAL DISPLAY PANEL

    Secondary

    Supergoop!

    Sun-Defying Sunscreen oil with Meadowfoam

    Broad Spectrum SPF 50

    5 Fl. Oz. / 148 ml

  • INGREDIENTS AND APPEARANCE
    SUN-DEFYING SUNSCREEN OIL BROAD SPECTRUM SPF 50   SUPERGOOP
    avobenzone, homosalate, octisalate, octocrylene, octinoxate oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-125
    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) HOMOSALATE15 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
    LAURYL LACTATE (UNII: G5SU0BFK7O)  
    ALARIA ESCULENTA (UNII: EJ9JK8J58D)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TOCOTRIENOLS (UNII: KP2MW85SSQ)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POMEGRANATE (UNII: 56687D1Z4D)  
    GRAPEFRUIT PEEL (UNII: 3582N05Q44)  
    ORANGE PEEL (UNII: TI9T76XD44)  
    TANGERINE PEEL (UNII: JU3D414057)  
    LEMON PEEL (UNII: 72O054U628)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-125-021 in 1 BOX12/03/2013
    1NDC:75936-125-01148 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    2NDC:75936-125-041 in 1 BOX12/03/2013
    2NDC:75936-125-0330 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:75936-125-061 in 1 BOX12/03/2013
    3NDC:75936-125-0510 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/03/2013
    Labeler - TAYLOR JAMES, LTD. (033381850)
    Registrant - TAYLOR JAMES, LTD. (033381850)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosway Company Inc052400223manufacture(75936-125)
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