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

SOL LEON Sunscreen SPF 15 by

Drug Labeling and Warnings

SOL LEON Sunscreen SPF 15 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%

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)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75944-100
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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75944-100-00	250 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