Label: SOL LEON SUNSCREEN SPF 15- avobenzone, homosalate, octisalate, octocrylene 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 10, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients

    Avobenzone         3%

    Homosalate         8%

    Octisalate            5%

    Octocrylene         8%

  • PURPOSE

    Purpose

    Sunscreen

  • INDICATIONS & USAGE

    Uses

    • Provides moderate protection against sunburn.
    • For skin that sunburns easily.
  • WARNINGS

    Warnings

    For External Use Only.

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

    Stop use and ask a doctor if rash or irritation develops and lasts

  • DOSAGE & ADMINISTRATION

    Directions

    • Apply evenly before sun exposure.
    • Children under 6 months of age, ask  a doctor.
    • Reapply as needed or after towel drying, swimming or perspiring.
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, caprylic/capric triglyceride, c12-15 alkyl benzoate, octocrylene, homosalate, butyl methoxydibenzoylmethane, tricontanyl pvp, cyclopentasioxane, glyceryl stearate, propylene glycol, glycerin, steareth-21, dimethicone, stearic acid, aloe barbadensis gel, maltodextrin, steareth-2, phenoxyethanol, ethylhexylsalycilate, bis-peg-18 methyl ether dimethyl silane, parfum (fragrance), glycine soja oil (soybean oil), peg-100 stearate, tocopheryl acetate, potassium sorbate, carbomer, oryza sativa cera (rice wax), methylparaben, ethylparaben, propylparaben, bisabolol, retinyl palmitate, alumina, panthenol, tetrasodium edta, silica, sodium polyacrylate, daucus carota extract (carrot root extract), lecithin, butylparaben, tocopherol. ascorbyl palmitate, sodium hydroxide, juglans regia leaf extract ( walnut extract), betacarotene, citric acid.

  • SPL UNCLASSIFIED SECTION

    Manufactured For:

    Bottega Di Lungavita Srl

    Via Verga, 14

    Bergamo, Italia I-24127

    Italy


    Made in Italy


    Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

    Ultra protection cream for the body and delicate areas of the face. It is particularly suitable for sensitive skin and ensures the perfect protection of children's delicate skin. Moisturizes and prevents sunburn, age-spots and skin rashes.

  • PRINCIPAL DISPLAY PANEL

    SOL

    LEON

    Sunscreen

    SPF 15

    UVA UVB

    MEDIUM PROTECTION

    Contains Carrot Extract

    Bottega Di

    Lungavita

    Natural Products

    Italian Style of Life

    8.45 fl oz (250 mL)

    SOLLEONaSOLLEONb



  • INGREDIENTS AND APPEARANCE
    SOL LEON SUNSCREEN SPF 15 
    avobenzone, homosalate, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75944-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mL  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE8 mL  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mL  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    OCTOCRYLENE (UNII: 5A68WGF6WM)  
    HOMOSALATE (UNII: V06SV4M95S)  
    AVOBENZONE (UNII: G63QQF2NOX)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARETH-21 (UNII: 53J3F32P58)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    STEARETH-2 (UNII: V56DFE46J5)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    OCTISALATE (UNII: 4X49Y0596W)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARROT (UNII: L56Z1JK48B)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    JUGLANS REGIA LEAF (UNII: 85HKB87105)  
    BETA CAROTENE (UNII: 01YAE03M7J)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75944-100-00250 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/15/2010
    Labeler - Bottega di Lungavita Srl (431933910)
    Establishment
    NameAddressID/FEIBusiness Operations
    O.F.I. Spa / OFI Officina Farmaceutica Italiana SpA 434907226manufacture
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