Label: MORPHE SPF 30 BROAD SPECTRUM SUNSETTER SETTING- octisalate, octocrylene, avobenzone, homosalate spray

  • NDC Code(s): 68577-151-01
  • Packager: COSMAX USA, CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 23, 2023

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  • ACTIVE INGREDIENT

    Active Ingredients

    Avobenzone 2%

    Homosalate 9%

    Octisalate 4.5%

    Octocrylene 2%

  • PURPOSE

    Purpose

    Sunscreen

  • USES

    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 cause by the sun
  • Warnings

    Warnings

    For extenal use only

    Flammable

    Flammable: Keep away from fire and flame.

    Do not useon damaged or broken skin

    When using this productkeep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor ifrash occurs

    Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    Directions

    • Apply evenly 15 minutes before sun exposure
      • Reapply
      • Reapply at least every 2 hours, or as needed
    • Use a water resistant sunscreen if swimming or sweating
      • 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 time in the sun, especially from 10 a.m. - 2p.m.

    -wear long-sleeved shirts, pants, hats and sunglasses

    Children under 6 months of age: Ask a doctor

  • OTHER INFORMATION

    Other information

    • Protect the product in this container from excessive heat and direct sun
    • May stain or damage some fabrics.
  • INACTIVE INGREDIENT

    Inactive ingredients: Alcohol Denat., Isododecane, Butyloctyl Salicylate, PVP, Fragrance, Benzyl Benzoate, Ethylcellulose, Sodium Acetate, Glycine Soja (Soybean) Oil, Polyglyceryl-3 Diisostearate, Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Germ Extract, Water, Glycerin, Cereus Grandiflorus (Cactus) Flower Extract, Potassium Sorbate, Phenoxyethanol, Citric Acid, Sodium Benzoate, Tropaeolum Majus Flower/Leaf/Steam Extract, Ethylhexylglycerin.

  • QUESTIONS or COMMENTS

    Questions or comments?

    1-8771-877-900-6700 Monday - Friday (9 a.m. - 5 p.m. EST)

  • PRINCIPAL DISPLAY PANEL

    BottlePrimary Package(Inner)

  • PRINCIPAL DISPLAY PANEL

    Outer Package

    Outer package

  • INGREDIENTS AND APPEARANCE
    MORPHE SPF 30 BROAD SPECTRUM SUNSETTER SETTING 
    octisalate, octocrylene, avobenzone, homosalate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68577-151
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 mg  in 100 mg
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE9 mg  in 100 mg
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2 mg  in 100 mg
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ISODODECANE (UNII: A8289P68Y2)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    POVIDONE (UNII: FZ989GH94E)  
    FRAGRANCE 13576 (UNII: 5EM498GW35)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
    SODIUM ACETATE (UNII: 4550K0SC9B)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    RICE GERM (UNII: 7N2B70SFEZ)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SELENICEREUS GRANDIFLORUS FLOWER (UNII: II877K4UNR)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TROPAEOLUM MAJUS FLOWERING TOP (UNII: RGT30824HY)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68577-151-011 in 1 CARTON06/01/2023
    1100 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/01/2023
    Labeler - COSMAX USA, CORPORATION (010990210)
    Registrant - COSMAX USA, CORPORATION (010990210)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSMAX USA. CORPORATION010990210manufacture(68577-151)
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