Label: VILLA FLORIANI CHAMOMILE CALMING DAY SPF 20- avobenzone, octocrylene, octinoxate, and octisalate lotion
- NDC Code(s): 68586-220-01, 68586-220-02, 68586-220-03
- Packager: Originitalia srl
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 23, 2019
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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
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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:
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- 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
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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
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INGREDIENTS AND APPEARANCE
VILLA FLORIANI CHAMOMILE CALMING DAY SPF 20
avobenzone, octocrylene, octinoxate, and octisalate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68586-220 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 90 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 35 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:68586-220-01 1 in 1 BOX 11/07/2016 1 50 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 2 NDC:68586-220-03 1 in 1 BOX 08/15/2018 2 20 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 3 NDC:68586-220-02 5 mL in 1 PACKET; Type 0: Not a Combination Product 11/07/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 11/07/2016 Labeler - Originitalia srl (441072253)
