NDC 71006-050 Rubelli Water Glow Sun

Octinoxate, Octisalate, Titanium Dioxide

NDC Product Code 71006-050

NDC 71006-050-02

Package Description: 1 TUBE in 1 CARTON > 40 mL in 1 TUBE (71006-050-01)

NDC Product Information

Rubelli Water Glow Sun with NDC 71006-050 is a a human over the counter drug product labeled by Rubelli Co.,ltd. The generic name of Rubelli Water Glow Sun is octinoxate, octisalate, titanium dioxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Rubelli Co.,ltd

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Rubelli Water Glow Sun 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 3 g/40mL
  • OCTISALATE 2 g/40mL
  • TITANIUM DIOXIDE 1.6 g/40mL

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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)

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: Rubelli Co.,ltd
Labeler Code: 71006
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: 06-01-2017 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: 12-31-2021 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.

Rubelli Water Glow Sun Product Label Images

Rubelli Water Glow Sun 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 Ingredient

Active ingredients: Ethylhexyl Methoxycinnamate 7.5%, Ethylhexyl Salicylate 5.0%, Titanium Dioxide 4.0%

Inactive Ingredient

Inactive ingredients: Water, Glycerin, Isoamyl p-Methoxycinnamate, Butylene Glycol, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Butylene Glycol Dicaprylate/Dicaprate, Polysorbate 60, Glyceryl Stearate, Cetearyl Alcohol, Sorbitan Stearate, VP/Eicosene Copolymer, Stearic Acid, PEG-100 Stearate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Ethylhexylglycerin, Caprylyl Glycol, Phenoxyethanol, Fragrance, Iron Oxides(CI77492), Tocopheryl Acetate, Polysorbate 80, Centella Asiatica Extract, Magnesium Aluminum Silicate, Iron Oxides(CI77491), Sorbitan Oleate, Iron Oxides(CI77499), Polygonum Cuspidatum Root Extract, Scutellaria Baicalensis Root Extract, Tropolone, Sodium Hyaluronate, Disodium EDTA, Caprylyl Glycol, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Chamomilla Recutita (Matricaria) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract

Purpose

Purpose: Sunscreen

Warnings

Warnings: For external use only 1. Please consult with a physician or other qualified health provider if you have abnormal symptoms such as red spot, swelling or itching, or side effects caused by exposure to direct sunlight, during or after use of the product,. 2. Avoid areas with wounds or other sensitive areas. 3. Precautions for storage and handling. Keep out of reach of children. Avoid direct exposure to sunlight.

Description

Uses: UV protection functional cosmetics with SPF40, PA++ which double-blocks ultraviolet UVA and UVB, and moisturizes the skin without tightness and has a refreshing feeling. In addition, it covers the skin tone with a gentle coverage without cloudiness and makes the skin beautiful that emits a radiant shine. BSASM™(Asiatic pennywort, Asiatic knotweed, Scutellaria baicalensis, green tea, licorice, chamomile flowers, rosemary leaf extract) which is seven plant complex patented ingredients are added, which calms down the skin tired by ultraviolet rays and makes the skin healthy.Directions: Apply an appropriate amount over the skin and evenly spread it.

* Please review the disclaimer below.