VILLA FLORIANI CHAMOMILE CALMING DAY SPF 20- avobenzone, octocrylene, octinoxate, and octisalate 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 Chamomile Calming Day Lotion SPF 20

Drug Facts

Active ingredientsPurpose
Avobenzone 3%Sunscreen
Octinoxate 3.5%Sunscreen
Octisalate 5%Sunscreen
Octocrylene 9%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. lf 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

lnactive ingredients

Water, C12-15 Alkyl Benzoate, Sorbitol, Cetearyl Isononanoate, Glycerin, Isononyl Isononanoate, Peucedanum Ostruthium Leaf Extract, Centella Asiatica Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Plantago Major Leaf Extract, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Helianthus Annuus (Sunflower) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Ammonium Glycyrrhizate, Olive Glycerides, Caffeine, Dicaprylyl Ether, Olea Europaea (Olive) Oil Unsaponifiables, Sodium Polyacrylate, Ceteareth-20, Cetearyl Alcohol, Mannitol, Silica, Glyceryl Stearate, Sodium PCA, PVP, Ceteareth-12, Cetyl Palmitate, Chlorphenesin, Zinc Gluconate, Sodium Phytate, Disodium EDTA, Benzyl Alcohol, Citric Acid, Ethylhexylglycerin, Phenoxyethanol, Dehydroacetic Acid, Sodium Benzoate, Sodium Dehydroacetate, Potassium Sorbate, Benzyl Salicylate, Limonene, Hexyl Cinnamal, Hydroxycitronellal, Citronellol, Eugenol, Cinnamyl Alcohol, Benzyl Benzoate, Linalool, Butylphenyl Methylpropional, Isoeugenol, Fragrance.

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Box

VILLA
FLORIANI

PHYTO-CURACTIVE SKINCARE™

CalmActive
SOOTHE & RESTORE

Chamomile Calming
Day Lotion

BROAD SPECTRUM
SPF 20
SUNSCREEN

sensitive

50 mL 1.69 Fl. Oz.

Principal Display Panel - 50 mL Bottle Box
VILLA FLORIANI CHAMOMILE CALMING DAY SPF 20 
avobenzone, octocrylene, octinoxate, and octisalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68586-220
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE90 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE35 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
SORBITOL (UNII: 506T60A25R)  
CETEARYL ISONONANOATE (UNII: P5O01U99NI)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
PEUCEDANUM OSTRUTHIUM LEAF (UNII: 86P27YRR6Y)  
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)  
CHAMOMILE (UNII: FGL3685T2X)  
PLANTAGO MAJOR LEAF (UNII: 7DC28K241X)  
HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
ROSEMARY (UNII: IJ67X351P9)  
JOJOBA OIL (UNII: 724GKU717M)  
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
CAFFEINE (UNII: 3G6A5W338E)  
DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
MANNITOL (UNII: 3OWL53L36A)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
CETEARETH-12 (UNII: 7V4MR24V5P)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
PHYTATE SODIUM (UNII: 88496G1ERL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
EUGENOL (UNII: 3T8H1794QW)  
CINNAMYL ALCOHOL (UNII: SS8YOP444F)  
BENZYL BENZOATE (UNII: N863NB338G)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
ISOEUGENOL (UNII: 5M0MWY797U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68586-220-011 in 1 BOX11/07/2016
150 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
2NDC:68586-220-031 in 1 BOX08/15/2018
220 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
3NDC:68586-220-025 mL in 1 PACKET; Type 0: Not a Combination Product11/07/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/07/2016
Labeler - Originitalia srl (441072253)

Revised: 1/2019
Document Id: 8026fded-44f7-36ce-e053-2991aa0aa770
Set id: 76559863-ce29-4957-9cb1-0613a195c0ba
Version: 4
Effective Time: 20190123
 
Originitalia srl