VILLA FLORIANI CHAMOMILE CALMING DAY SPF 20 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE, AND OCTISALATE) LOTION [ORIGINITALIA SRL]

VILLA FLORIANI CHAMOMILE CALMING DAY SPF 20 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE, AND OCTISALATE) LOTION [ORIGINITALIA SRL]
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NDC 68586-220-01, 68586-220-02, 68586-220-03
Set ID 76559863-ce29-4957-9cb1-0613a195c0ba
Category HUMAN OTC DRUG LABEL
Packager Originitalia srl
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Avobenzone 3%Sunscreen
    Octinoxate 3.5%Sunscreen
    Octisalate 5%Sunscreen
    Octocrylene 9%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. lf 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
  • 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
  • INGREDIENTS AND APPEARANCE
    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)

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