NDC 70680-308 Raw Elements Eco Formula Spf30 Sample Packs
Zinc Oxide Lotion Topical

Product Information

Raw Elements Eco Formula Spf30 Sample Packs is a human over the counter drug product labeled by Raw Elements Llc. The generic name of Raw Elements Eco Formula Spf30 Sample Packs is zinc oxide. The product's dosage form is lotion and is administered via topical form.

Product Code70680-308
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.
Raw Elements Eco Formula Spf30 Sample Packs
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.
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 FormLotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
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.
Raw Elements Llc
Labeler Code70680
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.
08-16-2019
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.
12-31-2022
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 Raw Elements Eco Formula Spf30 Sample Packs?


Product Packages

NDC 70680-308-00

Package Description: 4 g in 1 PACKET

Product Details

What are Raw Elements Eco Formula Spf30 Sample Packs 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.
  • ZINC OXIDE 230 mg/g - A mild astringent and topical protectant with some antiseptic action. It is also used in bandages, pastes, ointments, dental cements, and as a sunblock.

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.0076 MG/MG Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste

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.

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Raw Elements Eco Formula Spf30 Sample Packs Labeling and Warnings

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.

Table of Contents



Active Ingredient



Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)


Purpose



Anticavity

Sunscreen


Use



helps protect against cavities


Keep Out Of The Reach Of Children Under 6 Years Of Age.



If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Directions



adults and children 2 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 yearsask a dentist or physician


Inactive Ingredients



dicalcium phosphate dihydrate, water, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, sodium saccharin


Questions Or Comments?



Call toll-free 1-800-468-6502


Active Ingredients



Zinc Oxide 23%


Uses:



Helps prevent sunburn


Warnings:



For external use only.


Do Not Use



on damaged or broken skin.


Stop Use And Ask A Doctor



if skin rash occurs.


When Using This Product



keep out of eyes. Rinse with water to remove.


Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away.


Directions:



Apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating, Immediately after towel drying, at least every 2 hours. 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 value 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-sleeved shirts, pants, hats, and sunglasses.


Inactive Ingredients:



Camellia Sinensis Leaf Extract (Organic Green Tea), Camellia Sinensis Leaf Extract (Organic Black Tea), Cannabis Sativa Seed Oil (Organic Hemp Seed Oil), Cera Alba (Organic Beeswax), Coffea Arabica Seed Extract (Organic Coffee Bean), Helianthus Annuus Seed Oil (Organic Sunflower Oil), Mangifera Indica Seed Butter (Natural Mango Butter), Rosmarinus Officinalis Leaf Oil (Natural Rosemary), Theobroma Cacao Seed Butter (Organic Cocoa Butter), Tocopherol *Certified Organic


Other Information:



Protect this product from excessive heat and direct sun.


Package Labling: (72135-029-02)




Package Labling: (42555-060-94)




Package Labling: (70680-308-00)




* Please review the disclaimer below.