Label: SUPER POWER SUNSCREEN MOUSSE SPF 50 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 January 13, 2017

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

  • ACTIVE INGREDIENT

    ​Active Ingredients                  Purpose

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

    Homosalate 10% ...................... Sunscreen

    Octinoxate 7.5% ....................... Sunscreen

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

  • PURPOSE

    ​Uses

    Helps prevent sunburn

    • If used as directed with other sun protection measures (see Direction), 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 15 minutes before sun exposure
    • Reapply after 80 minutes of swimming or sweating
    • Immediately after towel drying
    • At least every 2 hours
    • Children under 6 months: Ask a doctor

    ​Sun Protection Measures ​Spending time in teh 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
  • INACTIVE INGREDIENT

    Aluminum Starch Octenylsuccinate, Ananas Sativus (Pineapple) Fuit Extract, Bis-Hydroxyethoxypropyl Dimethicone, Butter Extract, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Cananga Odorata Flower Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Chlorphenesin, Citrus Aurantium Dulcis (Orange) Peel Extract, Citrus Grandis (Grapefruit) Fruit Extract, Citrus Limon (Lemon) Peel Extract, Cocos Nucifera (Cocnut) Fruit Extract, Cocos Nucifera (Coconut) Oil, Arabica (Coffee) Seed Extract, Crambe Maritima Leaf Extract, Cucumis Melo Cantalupensis Fruit Extract, Cucumis Sativus (Cucumber) Fruit Extract, Diethylhexyl Syringylidenemalonate, Disodium EDTA, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Glyceryl Undecylenate, Hydrofluorocarbon 152A, Olea Europaea (Olive) Fruit Oil, Panthenol, Passiflora Incarnata Fruit Extract, Persea Gratissima (Avocado) Oil, Polyester-5, Potassium Cetyl Phosphate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Prunus Amygdalus Dulcis (Sweet Almond) Seed Extract, Prunus Armeniaca (Apricot) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Rose Extract, Rubus Idaeus (Raspberry) Fruit Extract, Santalum Album (Sandalwood) Extract, Simmondsia Chinesis (Jojoba) Seed Oil, Tocopherol, Trehalose, Vanilla Planifolia Fruit Extract, Water

  • PRINCIPAL DISPLAY PANEL

    Super Power

    Sunscreen

    MOUSSE

    Broad Spectrum SPF 50

    Water resistant (80 minutes)

    Supergoop!

    7.1 fl. oz. / 200 mL

    Label

  • INGREDIENTS AND APPEARANCE
    SUPER POWER SUNSCREEN MOUSSE SPF 50  SUPERGOOP
    avobenzone, homosalate, octinoxate, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-504
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 kg  in 100 kg
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 kg  in 100 kg
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 kg  in 100 kg
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 kg  in 100 kg
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    PINEAPPLE (UNII: 2A88ZO081O)  
    BIS-HYDROXYETHOXYPROPYL DIMETHICONE (37 CST) (UNII: 7K226YI89Y)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CANANGA ODORATA FLOWER (UNII: 76GTF6Z97M)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    ORANGE PEEL (UNII: TI9T76XD44)  
    GRAPEFRUIT (UNII: O82C39RR8C)  
    LEMON PEEL (UNII: 72O054U628)  
    COCONUT (UNII: 3RT3536DHY)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ARABICA COFFEE BEAN (UNII: 3SW678MX72)  
    CRAMBE MARITIMA LEAF (UNII: NO0DI2V62B)  
    CANTALOUPE (UNII: 8QF5D5H6UH)  
    CUCUMBER (UNII: YY7C30VXJT)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
    1,1-DIFLUOROETHANE (UNII: 0B1U8K2ME0)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    POLYESTER-5 (TG-38) (UNII: 2L9351NW8W)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    ALMOND (UNII: 3Z252A2K9G)  
    APRICOT (UNII: 269CJD5GZ9)  
    APPLE (UNII: B423VGH5S9)  
    RASPBERRY (UNII: 4N14V5R27W)  
    SANDALWOOD (UNII: 3641YW25N2)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TREHALOSE (UNII: B8WCK70T7I)  
    VANILLA (UNII: Q74T35078H)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-504-1178.4 kg in 1 DRUM; Type 0: Not a Combination Product01/13/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/13/2017
    Labeler - TAYLOR JAMES, LTD. (033381850)
    Registrant - TAYLOR JAMES, LTD. (033381850)
    Establishment
    NameAddressID/FEIBusiness Operations
    Chemolee Lab Corporation809982754manufacture(75936-504)