Label: VILLA FLORIANI ALOE ULTRA-HYDRATING DAY SPF 20- avobenzone, octinoxate, octisalate, octocrylene lotion
- NDC Code(s): 68586-225-01
- Packager: Originitalia srl
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 June 7, 2019
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Purpose
- Uses
- 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:
- 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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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
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INGREDIENTS AND APPEARANCE
VILLA FLORIANI ALOE ULTRA-HYDRATING DAY SPF 20
avobenzone, octinoxate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68586-225 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 35 mg in 1 mL 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 Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/07/2019 Labeler - Originitalia srl (441072253) Registrant - Originitalia srl (441072253)
