NDC 68586-225 Villa Floriani Aloe Ultra-hydrating Day Spf 20

Avobenzone, Octinoxate, Octisalate, Octocrylene

NDC Product Code 68586-225

NDC Code: 68586-225

Proprietary Name: Villa Floriani Aloe Ultra-hydrating Day Spf 20 What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Avobenzone, Octinoxate, Octisalate, Octocrylene What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 68586 - Originitalia Srl
    • 68586-225 - Villa Floriani Aloe Ultra-hydrating Day Spf 20

NDC 68586-225-01

Package Description: 1 BOTTLE, GLASS in 1 BOX > 50 mL in 1 BOTTLE, GLASS

NDC Product Information

Villa Floriani Aloe Ultra-hydrating Day Spf 20 with NDC 68586-225 is a a human over the counter drug product labeled by Originitalia Srl. The generic name of Villa Floriani Aloe Ultra-hydrating Day Spf 20 is avobenzone, octinoxate, octisalate, octocrylene. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Originitalia Srl

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Villa Floriani Aloe Ultra-hydrating Day Spf 20 Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • OCTINOXATE 35 mg/mL
  • AVOBENZONE 30 mg/mL
  • OCTOCRYLENE 90 mg/mL
  • OCTISALATE 50 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Originitalia Srl
Labeler Code: 68586
FDA Application Number: part352 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-07-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Villa Floriani Aloe Ultra-hydrating Day Spf 20 Product Label Images

Villa Floriani Aloe Ultra-hydrating Day Spf 20 Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

Avobenzone 3%Octinoxate 3.5%Octisalate 5%Octocrylene 9%

Purpose

Sunscreen

Uses

  • Helps prevent sunburnif 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

Otc - Do Not Use

Do not use on damaged or broken skin.

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if rash occurs.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally 15 minutes before sun exposureapply to all skin exposed to the sunchildren under 6 months: Ask a doctorSun 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 sunglassesreapply at least every 2 hoursuse a water-resistant sunscreen if swimming or sweating

Other Information

  • Protect this product from excessive heat and direct sunyou may report a serious adverse reaction to this product to: Report Reaction, LLC PO Box 22 Plainsboro, NJ 08536-0222

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 ItalyOriginitalia srl - 36030 Caldogno (VI) Italywww.villafloriani.com

Product Packaging

HydraActiveNOURISH & REPLENISHAloe Ultra-Hydrating Day LotionBROAD SPECTRUMSPF 20SUNSCREENnormal/dry50 mL 1.69 Fl. Oz.

* Please review the disclaimer below.