Label: DEGIL SUN SPF 50 SUNSCREEN- homosalate, octisalate, oxybenzone, avobenzone, octocrylene lotion

  • NDC Code(s): 58331-075-01, 58331-075-03
  • Packager: Degil Safety Products (1989) Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 5, 2024

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  • ACTIVE INGREDIENT

    Homosalate 13%

    Octisalate 5%

    Oxybenzone 4%

    Avobenzone 3%

    Octocrylene 7%

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    Sun Protection Factor 50 • SPF 50 • Helps prevent sunburn • Sunburn protectant

    • Helps protect from sunburn • If used as directed with other sun protection measures [see Directions (for Use)], decreases the risk of skin cancer and early skin aging caused by the sun • Water Resistant (80 minutes)

  • WARNINGS

    For external use only

    Do not use on broken skin

    When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water

    Stop use and ask a doctor if rash occurs

    If swallowed, call a poison control centre or get medical help right away.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INSTRUCTIONS FOR USE

    Adults and children over 6 months of age • Apply liberally/generously (and evenly) 15 minutes before sun exposure • 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 time in the sun, especially from 11 a.m. – 3 p.m.; and ▪ wear long-sleeved shirts, pants, hats and sunglasses • Reapply after 80 minutes of swimming or sweating • Reapply immediately after towel drying

  • INACTIVE INGREDIENT

    Aqua, Sorbitol, Aluminium Starch Octenylsuccinate , VP / Eicosene Copolymer, Stearic acid, Triethanolamine, Sorbitan Isostearate, Benzyl Alcohol, Dimethicone, Palmitic acid, Polyglyceryl-3 Distearate, Carbomer, Methylparaben, Propylparaben, Vitamin E, Disodium EDTA

  • USER SAFETY WARNINGS

    Other information

    Protect the product from excessive heat and direct sun

    Questions? 1-800-332-1810 / sales@delta-plus.ca

  • PRINCIPAL DISPLAY PANEL

    DEGIL Sun 50 SPF FPS

    SUNSCREEN

    Broad Spectrum
    UVA & UBV Protection

    Protection UVA & UVB

    Dermatologist Tested. Moisturizing Aloe &
    Vitamin E. Unscented Lotion.
    Water Resistant (80 minutes).

    DIN 02543443

    120 mL(4 fl.oz.)/750 mL(25 fl.oz.)

    Distributed by
    Degil Safety Products (1989) Inc.
    Vaughan,ontario,Canada L4H 0L6
    MADE IN CANADA label

    Lotion

    Topical

  • INGREDIENTS AND APPEARANCE
    DEGIL SUN SPF 50 SUNSCREEN 
    homosalate, octisalate, oxybenzone, avobenzone, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58331-075
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    SORBITOL (UNII: 506T60A25R)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58331-075-01120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package05/06/2024
    2NDC:58331-075-03750 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package05/06/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/01/2024
    Labeler - Degil Safety Products (1989) Inc (247083686)
    Establishment
    NameAddressID/FEIBusiness Operations
    HK Kolmar Canada243501959manufacture(58331-075)
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