VILLA FLORIANI MINT PURIFYING DAY SPF 20- avobenzone, octocrylene, octinoxate, and octisalate lotion

Villa Floriani Mint Purifying Day SPF 20 by

Drug Labeling and Warnings

Villa Floriani Mint Purifying Day SPF 20 by is a Otc medication manufactured, distributed, or labeled by Originitalia srl. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Avobenzone 3%	Sunscreen
Octinoxate 3.5%	Sunscreen
Octisalate 5%	Sunscreen
Octocrylene 9%	Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. lf product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
• apply to all skin exposed to the sun
• children under 6 months: Ask a doctor

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:

• • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
• reapply at least every 2 hours
• use a water-resistant sunscreen if swimming or sweating

Other information

• protect this product from excessive heat and direct sun
• you may report a serious adverse reaction to this product to: Report Reaction, LLC PO Box 22 Plainsboro, NJ 08536-0222

lnactive ingredients

Water, C12-15 Alkyl Benzoate, Sorbitol, Cetearyl Isononanoate, Butylene Glycol, Isononyl Isononanoate, Dicaprylyl Carbonate, Simmondsia Chinensis (Jojoba) Seed Oil, Macadamia Ternifolia Seed Oil, Fomes Officinalis (Mushroom) Extract, Olea Europaea (Olive) Oil Unsaponifiables, Malva Sylvestris (Mallow) Flower/Leaf Extract, Arctium Lappa Root Extract, Mentha Piperita (Peppermint) Leaf Extract, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Helianthus Annuus (Sunflower) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Silica, Ceteareth-20, Cetearyl Alcohol, Ceteareth-12, Cetyl Palmitate, Glycerin, Glyceryl Stearate, Sodium Polyacrylate, Citric Acid, Sodium Phytate, Chlorphenesin, PVP, Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol, Dehydroacetic Acid, Benzyl Alcohol, Sodium Benzoate, Potassium Sorbate, Limonene, Butylphenyl Methylpropional, Hexyl Cinnamal, Eugenol, Citronellol, Fragrance.

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Box

VILLA
FLORIANI
PHYTO-CURACTIVE SKINCARE™

PureActive
BALANCE & CONTROL

Mint Purifying
Day Lotion

BROAD SPECTRUM
SPF 20
SUNSCREEN

normal / oily

50 mL 1.69 Fl. Oz.

INGREDIENTS AND APPEARANCE

VILLA FLORIANI MINT PURIFYING DAY SPF 20 
avobenzone, octocrylene, octinoxate, and octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68586-219
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	90 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	35 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETEARETH-12 (UNII: 7V4MR24V5P)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
CHLORPHENESIN (UNII: I670DAL4SZ)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EUGENOL (UNII: 3T8H1794QW)
LARICIFOMES OFFICINALIS FRUITING BODY (UNII: 7IFM8431X3)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)
SUNFLOWER OIL (UNII: 3W1JG795YI)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
MACADAMIA OIL (UNII: 515610SU8C)
MALVA SYLVESTRIS FLOWERING TOP (UNII: X1U1U0N90J)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
ROSEMARY (UNII: IJ67X351P9)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
JOJOBA OIL (UNII: 724GKU717M)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PHYTATE SODIUM (UNII: 88496G1ERL)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
SORBITOL (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68586-219-01	1 in 1 BOX	08/22/2016
1		50 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
2	NDC: 68586-219-02	5 mL in 1 PACKET; Type 0: Not a Combination Product	08/22/2016
3	NDC: 68586-219-03	1 in 1 BOX	03/15/2019
3		20 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/22/2016

Labeler - Originitalia srl (441072253)