Label: SOL LEON SUNSCREEN SPF 30- avobenzone, homosalate, octisalate, octocrylene, octinoxate 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%

    Octinoxate           7.5%

  • 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, c12-15 alkyl benzoate, homosalate octocrylene, ethylhexylmethoxycinnamate, Glycerin, cocglycerides, dimethicone, tridecyl salicylate, Ethylhexyl salycilate, butyl methoxydibenzoylmethane, tricontanyl pvp, glyceryl stearate, steareth-21, stearic acid, caprylic/capric triglyceride, aloe barbadensis gel, Maltodextrin, steareth-2, phenoxyethanol, parfum, Fragrance, peg-100 stearate, tocopheryl acetate, Xanthan gum, daucus carota extract (carrot extract), Potassium sorbate, alumina, oryza sativa cera ( rice wax),  methylparaben, acrylates c10-30 alkyl acrylate Crosspolymer, dichlorobenzyl alcohol, ethylparaben, propylparaben, bisabolol, retinyl palmitate, propylene glycol, silica, panthenol, sodium polyacrylate, Hydrolyzed rice protein, hydrolyzed vegetable protein, tetrasodium edta, glicerina, sodium hydroxide, butylparaben, juglans regia leaf extract (walnut extract), BHT.

  • 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 sun cream particularly suitable for children and those with fair and delicate skins. It ensures protection against sunburn and prevents skin rashes and age-spots.

  • PRINCIPAL DISPLAY PANEL

    SOL

    LEON

    Sunscreen

    SPF 30

    UVA UVB

    HIGH PROTECTION

    Contains Carrot Extract

    Bottega Di

    Lungavita

    Natural Products

    Italian Style of Life

    6.76 fl oz (200 mL)

    SOLLEONaSOLLEONb



  • INGREDIENTS AND APPEARANCE
    SOL LEON SUNSCREEN SPF 30 
    avobenzone, homosalate, octisalate, octocrylene, octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75944-200
    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
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    HOMOSALATE (UNII: V06SV4M95S)  
    OCTOCRYLENE (UNII: 5A68WGF6WM)  
    OCTINOXATE (UNII: 4Y5P7MUD51)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCO-GLYCERIDES (UNII: ISE9I7DNUG)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    OCTISALATE (UNII: 4X49Y0596W)  
    AVOBENZONE (UNII: G63QQF2NOX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    STEARETH-21 (UNII: 53J3F32P58)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    STEARETH-2 (UNII: V56DFE46J5)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARROT (UNII: L56Z1JK48B)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DICHLOROBENZYL ALCOHOL (UNII: 1NKX3648J9)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    JUGLANS REGIA LEAF (UNII: 85HKB87105)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75944-200-00200 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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