SOL LEON SUNSCREEN SPF 30- avobenzone, homosalate, octisalate, octocrylene, octinoxate cream

SOL LEON Sunscreen SPF 30 by

Drug Labeling and Warnings

SOL LEON Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by Bottega di Lungavita Srl, O.F.I. Spa / OFI Officina Farmaceutica Italiana SpA . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

SOL LEON SUNSCREEN SPF 30 
avobenzone, homosalate, octisalate, octocrylene, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75944-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mL  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	8 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mL  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 mL  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75944-200-00	200 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/15/2010

Labeler - Bottega di Lungavita Srl (431933910)

Establishment
Name	Address	ID/FEI	Business Operations
O.F.I. Spa / OFI Officina Farmaceutica Italiana SpA		434907226	manufacture