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

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VILLA FLORIANI ALOE ULTRA-HYDRATING DAY LOTION SPF 20

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).

Product Packaging

HydraActive

NOURISH & REPLENISH

Aloe Ultra-Hydrating Day Lotion

BROAD SPECTRUM

SPF 20

SUNSCREEN

normal/dry

50 mL 1.69 Fl. Oz.

aloe

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	35 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
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)
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	06/07/2019	12/31/2023

Labeler - Originitalia srl (441072253)

Registrant - Originitalia srl (441072253)

Revised: 8/2024

Document Id: 20995ef2-c1db-0872-e063-6394a90a58a0

Set id: 8abf339f-0a48-68e7-e053-2a95a90abcfe

Version: 2

Effective Time: 20240826

Originitalia srl