NDC 81647-070 Arocell Tone Up Perfect Sun

Zinc Oxide, Titanium Dioxide

NDC Product Code 81647-070

NDC 81647-070-02

Package Description: 1 TUBE in 1 CARTON > 50 g in 1 TUBE (81647-070-01)

NDC Product Information

Arocell Tone Up Perfect Sun with NDC 81647-070 is a a human over the counter drug product labeled by Ficc Co., Ltd.. The generic name of Arocell Tone Up Perfect Sun is zinc oxide, titanium dioxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Ficc 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.

Arocell Tone Up Perfect 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.

  • ZINC OXIDE 5.82 g/50g
  • TITANIUM DIOXIDE 1.84 g/50g

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.

  • CYCLOMETHICONE (UNII: NMQ347994Z)
  • DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
  • 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: Ficc Co., Ltd.
Labeler Code: 81647
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: 03-01-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Arocell Tone Up Perfect Sun Product Label Images

Arocell Tone Up Perfect 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 Ingredients

ZINC OXIDE 11.64%TITANIUM DIOXIDE 3.68%

Inactive Ingredients

Cyclomethicone, Dicaprylyl Carbonate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Glycerin, Ethylhexyl Palmitate, Caprylyl Methicone, Diphenylsiloxy Phenyl Trimethicone, Dipropylene Glycol, Niacinamide, Polyglyceryl-2 Dipolyhydroxystearate, Polymethylsilsesquioxane, Calamine, Polyhydroxystearic Acid, Disteardimonium Hectorite, Sodium Chloride, Triethoxycaprylylsilane, Aluminum Hydroxide, Synthetic Beeswax, Caprylic/Capric Triglyceride, Stearic Acid, Caprylyl Glycol, Fragrance(Parfum), Glyceryl Caprylate, C12-15 Alkyl Benzoate, Adenosine, Polyglyceryl-2 Triisostearate, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Tocopherol, Isostearic Acid, Citrus Junos Fruit Oil, Polymethyl Methacrylate, Polyvinyl Alcohol

Purpose

Sunscreen

Warnings

For external use onlyConsult a specialist if there are abnormal symptoms or side effects such as redness, swelling or itchiness due to direct sunlight during or after use.Avoid using on wounded areas.Keep out of reach of children

Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

Uses

■ Helps prevent sun burn

Directions

■ Apply liberally and uniformly to all exposed areas 15-20 minutes before sun exposure.

Other Information

■ Keep away from direct sunlight.

* Please review the disclaimer below.