SOL LEON SUNSCREEN SPF 30 - avobenzone, homosalate, octisalate, octocrylene, octinoxate cream 
Bottega di Lungavita Srl

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.

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SOL LEON Sunscreen SPF 30

Drug Facts

Active Ingredients

Avobenzone         3%

Homosalate         8%

Octisalate            5%

Octocrylene         8%

Octinoxate           7.5%

Purpose

Sunscreen

Uses

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

Directions

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.

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.

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



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

Revised: 1/2011
Document Id: 4c218401-e440-4a07-80da-5fbb6041a552
Set id: 0b0a0312-71e6-426e-90ce-69c64533af89
Version: 1
Effective Time: 20110110
 
Bottega di Lungavita Srl