![VILLA FLORIANI MINT PURIFYING DAY SPF 20 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE, AND OCTISALATE) LOTION [ORIGINITALIA SRL]](https://medic.hrt.org//dailymed/images/fc398166-3b2e-4da4-8930-a672bdfcbac0/villa-01.jpg)
| NDC | 68586-219-01, 68586-219-02, 68586-219-03 |
| Set ID | fc398166-3b2e-4da4-8930-a672bdfcbac0 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Originitalia srl |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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
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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:
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- 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
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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
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INGREDIENTS AND APPEARANCE
VILLA FLORIANI MINT PURIFYING DAY SPF 20
avobenzone, octocrylene, octinoxate, and octisalate lotionProduct 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)
