VILLA FLORIANI ALOE ULTRA-HYDRATING DAY SPF 20- avobenzone, octinoxate, octisalate, octocrylene lotion

VILLA FLORIANI ALOE ULTRA-HYDRATING DAY SPF 20 by

Drug Labeling and Warnings

VILLA FLORIANI ALOE ULTRA-HYDRATING DAY SPF 20 by is a Otc medication manufactured, distributed, or labeled by Originitalia srl. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Avobenzone 3%

Octinoxate 3.5%

Octisalate 5%

Octocrylene 9%

Purpose

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. If 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

Inactive ingredients

Aqua (Water), C12-15 Alkyl Benzoate, Sorbitol, Cetearyl Isononanoate, Isononyl Isononanoate, Argania Spinosa Kernel Oil, Persea Gratissima (Avocado) Oil, Rosa Moschata Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Sodium Hyaluronate, Althaea Officinalis Root Extract, Rosa Canina Fruit Extract, Tilia Tomentosa Extract, Aloe Barbadensis Leaf Juice, Evernia Prunastri (Oakmoss) Extract, Phospholipids, Sphingolipids, Spirulina Platensis Extract, Trehalose, Palmitoyl Tripeptide-5, Serine, Algin, Pullulan, Ceteareth-20, Cetearyl Alcohol, Ceteareth-12, Cetyl Palmitate Sodium Polyacrylate, Glyceryl Polyacrylate, Dicaprylyl Carbonate, PVP, Sodium Phytate, Glyceryl Stearate, Glycerin, Pentylene Glycol, Caprylyl Glycol, Disodium Phosphate, Disodium EDTA, Potassium Phosphate, Silica, Urea, Citric Acid, Benzyl Alcohol, Sodium Benzoate, Potassium Sorbate, Chlorphenesin, Ethylhexylglycerin, Phenoxyethanol, Dehydroacetic Acid, Linalool, Limonene, Coumarin, Citral, Parfum (Fragrance).

Company Information

Made in Italy

Originitalia srl - 36030 Caldogno (VI) Italy

www.villafloriani.com

Product Packaging

HydraActive

NOURISH & REPLENISH

Aloe Ultra-Hydrating Day Lotion

BROAD SPECTRUM

SPF 20

SUNSCREEN

normal/dry

50 mL 1.69 Fl. Oz.

INGREDIENTS AND APPEARANCE

VILLA FLORIANI ALOE ULTRA-HYDRATING DAY SPF 20 
avobenzone, octinoxate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68586-225
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARETH-12 (UNII: 7V4MR24V5P)
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TILIA TOMENTOSA WHOLE (UNII: 744437C6KV)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SPIRULINA PLATENSIS (UNII: 9L3TIH1UUE)
PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
AVOCADO OIL (UNII: 6VNO72PFC1)
ROSA MOSCHATA SEED OIL (UNII: T031ZE559T)
PULLULAN (UNII: 8ZQ0AYU1TT)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
SUNFLOWER OIL (UNII: 3W1JG795YI)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
EVERNIA PRUNASTRI (UNII: O3034Q5AHK)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
GLYCERIN (UNII: PDC6A3C0OX)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
CITRAL (UNII: T7EU0O9VPP)
UREA (UNII: 8W8T17847W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
COUMARIN (UNII: A4VZ22K1WT)
TREHALOSE (UNII: B8WCK70T7I)
SERINE (UNII: 452VLY9402)
PHYTATE SODIUM (UNII: 88496G1ERL)
CHLORPHENESIN (UNII: I670DAL4SZ)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
ARGAN OIL (UNII: 4V59G5UW9X)
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)
ROSA CANINA FRUIT (UNII: 3TNW8D08V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68586-225-01	1 in 1 BOX	06/07/2019
1		50 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 not final	part352	06/07/2019

Labeler - Originitalia srl (441072253)

Registrant - Originitalia srl (441072253)