SOL LEON SUNSCREEN SPF 15 - avobenzone, homosalate, octisalate, octocrylene  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 15

Drug Facts

Active Ingredients

Avobenzone         3%

Homosalate         8%

Octisalate            5%

Octocrylene         8%

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, 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.

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.

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



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

Revised: 1/2011
Document Id: b1e56151-1121-47fa-9dfa-d59fbb0a6f5f
Set id: ca13ec81-1ddb-40d5-8f58-510a9f42d42a
Version: 1
Effective Time: 20110110
 
Bottega di Lungavita Srl