NDC 70668-828 Natural Blend Spf 30 Sunscreen
Titanium Dioxide, Zinc Oxide Cream Topical

Product Information

What is NDC 70668-828?

The NDC code 70668-828 is assigned by the FDA to the product Natural Blend Spf 30 Sunscreen which is a human over the counter drug product labeled by Products On The Go, Llc. The generic name of Natural Blend Spf 30 Sunscreen is titanium dioxide, zinc oxide. The product's dosage form is cream and is administered via topical form. The product is distributed in a single package with assigned NDC code 70668-828-01 5 ml in 1 packet . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code70668-828
Proprietary Name 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.
Natural Blend Spf 30 Sunscreen
Non-Proprietary Name 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.
Titanium Dioxide, Zinc Oxide
Product Type 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.
Human Otc Drug
Dosage FormCream - 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.
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.
Products On The Go, Llc
Labeler Code70668
FDA Application Number 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.
part352
Marketing Category 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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
05-10-2017
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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".
N
NDC Code Structure

What are the uses for Natural Blend Spf 30 Sunscreen?


Product Packages

NDC Code 70668-828-01

Package Description: 5 mL in 1 PACKET

Product Details

What are Natural Blend Spf 30 Sunscreen Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Natural Blend Spf 30 Sunscreen Active Ingredients UNII Codes

Natural Blend Spf 30 Sunscreen Inactive Ingredients UNII Codes

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.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Natural Blend Spf 30 Sunscreen Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Active Ingredient:



Titanium dioxide 6%

Zinc Oxide 6%


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:



  • For external use only.

Do Not Use



on damaged or broken skin.


When Using This Product



  • keep out of eyes. Rinse with water to remove. 

Stop Use And Consult Physician



if irritation or rash develops.


Keep Out Of Reach Of Children.



If product is swallowed, get medical attention or contact poison control center immediately.


Direction:



  • Apply liberally 15-minutes before sun exposure.
  • Reapply
  • At least every two-hours.
  • Immediately after swimming, sweating or towel drying.
  • SUN PROTECTION MEASURES: Spending time in the sun increase your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including:
  • Limit time in the sun, especially between 10am and 2pm.
  • Wear long sleeve shirts, pants, hats and sunglasses.
  • For children under 6-months, consult a physician.

Other Ingredients:



Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Extract, Daucus Carota Sativa (Carrot) Extract, Gluconolactone, Sodium Benzoate, Ethylhexyl Palmitate, Glycerin, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Extract, Lecithin, Phenoxyethanol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Red Glitter, Sesamum Indicum (Sesame) Oil, Theobroma Cacao (Cocoa) Butter, Tocopherol (Vitamin E), Xanthan Gum.


Package Labeling:




* Please review the disclaimer below.