Label: PLAY BODY MOUSSE WITH BLUE SEA KALE BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate cream

  • NDC Code(s): 75936-227-01, 75936-227-02
  • Packager: Taylor James, Ltd.
  • 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 April 14, 2020

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

  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Avobenzone3% Sunscreen

    Homosalate 15% 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

    If product is swallowed, get medical help or contact a poison Control Center right away

  • INDICATIONS & USAGE

    Stop use and ask a doctor if

    rash occurs or irritation develops and lasts.

  • 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

    Apply generously and evenly 15 minutes before sun exposure
    Use a water-resistant sunscreen if swimming or sweating
    Reapply at least every 2 hours.
    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 your 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 INGREDIENT

    Inactive Ingredients

    Aluminum Starch Octenylsuccinate, Ananas Sativus (Pineapple) Fruit Extract, Bis-Hydroxyethoxypropyl Dimethicone,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 (Coconut) Fruit Extract, Cocos Nucifera (Coconut) Oil, Coffea 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, Olea Europaea (Olive) Fruit Oil, Panthenol, Passiflora Incarnata Fruit Extract, Persea Gratissima (Avocado) Oil, Polyester-5, Potassium Cetyl Phosphate, 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 Chinensis (Jojoba) Seed Oil, Theobroma Cacao (Cocoa) Seed Extract, Tocopherol, Trehalose, Vanilla Planifolia Fruit Extract, Water

  • PRINCIPAL DISPLAY PANEL

    Supergoop!

    PLAY

    SPF 50

    Body Mousse With Blue Sea Kale

    Broad Spectrum Suncreen SPF 50

    Water and Sweat Resistant (80 minutes)

    84 ml e 86 g 3.0 oz

    Body Mousse 50

  • INGREDIENTS AND APPEARANCE
    PLAY BODY MOUSSE WITH BLUE SEA KALE BROAD SPECTRUM SPF 50 
    avobenzone, homosalate, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-227
    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
    Inactive Ingredients
    Ingredient NameStrength
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    APPLE (UNII: B423VGH5S9)  
    COCONUT (UNII: 3RT3536DHY)  
    ARABICA COFFEE BEAN (UNII: 3SW678MX72)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
    VANILLA BEAN (UNII: Q74T35078H)  
    CANTALOUPE (UNII: 8QF5D5H6UH)  
    CUCUMBER (UNII: YY7C30VXJT)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    ALMOND (UNII: 3Z252A2K9G)  
    RASPBERRY (UNII: 4N14V5R27W)  
    TREHALOSE (UNII: B8WCK70T7I)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    POLYESTER-5 (TG-48) (UNII: 791E7S99Q2)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    SANDALWOOD (UNII: 3641YW25N2)  
    COCOA (UNII: D9108TZ9KG)  
    PUMMELO (UNII: ET1TN5W71X)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    LEMON PEEL (UNII: 72O054U628)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    ORANGE PEEL (UNII: TI9T76XD44)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    CANANGA ODORATA FLOWER (UNII: 76GTF6Z97M)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)  
    APRICOT (UNII: 269CJD5GZ9)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CRAMBE MARITIMA LEAF (UNII: NO0DI2V62B)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    PINEAPPLE (UNII: 2A88ZO081O)  
    BIS-HYDROXYETHOXYPROPYL DIMETHICONE (37 CST) (UNII: 7K226YI89Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-227-0184 mL in 1 CAN; Type 0: Not a Combination Product04/02/2020
    2NDC:75936-227-02181 mL in 1 CAN; Type 0: Not a Combination Product04/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/02/2020
    Labeler - Taylor James, Ltd. (033381850)
    Establishment
    NameAddressID/FEIBusiness Operations
    Chemolee Lab Corporation809982754manufacture(75936-227)