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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

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

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:

Other information

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.

aloe

VILLA FLORIANI ALOE ULTRA-HYDRATING DAY SPF 20 
avobenzone, octinoxate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68586-225
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE35 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE90 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68586-225-011 in 1 BOX06/07/2019
150 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/07/2019
Labeler - Originitalia srl (441072253)
Registrant - Originitalia srl (441072253)

Revised: 6/2019
Document Id: 8abf339f-0a49-68e7-e053-2a95a90abcfe
Set id: 8abf339f-0a48-68e7-e053-2a95a90abcfe
Version: 1
Effective Time: 20190607
 
Originitalia srl