Label: CHEMICAL SUNSCREEN SPF50- octisalate, avobenzone, homosalate, octocrylene sunscreen spray

  • NDC Code(s): 60232-0043-1
  • Packager: Swiss-American CDMO, LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 8, 2024

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  • 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. Stop use and ask a physician if rash occurs. If product is swallowed get medical help or contact a Poison Control Center right away.

  • Uses

    Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

  • Directions

    Apply liberally 15 minutes before sun exposure. Reapply after 40 minutes of swimming or sweating, immediately after towel drying and 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.

  • Active Ingredients

    Avobenzone 3.0% Sunscreen
    Octisalate 5.0% Sunscreen
    Octocrylene 10.0% Sunscreen
    Homosalate 15.0% Sunscreen

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN 

  • Inactive Ingredients

    Water, Dicaprylyl Carbhonate, Triheptanoin C13-16 Isoalkane, Butyloctyl Salicylate, Glycerin, Ethylhexyl Methoxycrylene, Triacontanyl PVP, Phenoxyethanol, Ethylhexylglycerin, Ceterayl Alcohol, Coco-
    Glucoside, Glucose, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexane, Polysorbate 60, Sorbitan Isostearate.

  • Purpose

    Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

  • Questions

    Call toll free 1-866-416-2366

  • Labeling

    PL043 Drug Facts

  • INGREDIENTS AND APPEARANCE
    CHEMICAL SUNSCREEN SPF50 
    octisalate, avobenzone, homosalate, octocrylene sunscreen spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60232-0043
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 g  in 1000 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 g  in 1000 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE150 g  in 1000 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 g  in 1000 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    TRIHEPTANOIN (UNII: 2P6O7CFW5K)  
    COCO-GLUCOSIDE (UNII: ICS790225B)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    TRIACONTANYL PVP (WP-660) (UNII: N0SS3Q238D)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60232-0043-190 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/29/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/29/2024
    Labeler - Swiss-American CDMO, LLC (080170933)
    Registrant - Swiss-American CDMO, LLC (080170933)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss-American CDMO, LLC080170933manufacture(60232-0043)
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