One And Done
Spf 40
Thirteen Lune Inc.
Human Otc Drug
NDC 82735-200One And Done also known as Spf 40 is a human otc drug labeled by 'Thirteen Lune Inc.'. National Drug Code (NDC) number for One And Done is 82735-200. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in One And Done drug includes Titanium Dioxide - 2 g/100mL Zinc Oxide - 1 g/100mL . The currest status of One And Done drug is Active.
Drug Information:
| Drug NDC: | 82735-200 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | One And Done |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Spf 40 |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Thirteen Lune Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | TITANIUM DIOXIDE - 2 g/100mL
ZINC OXIDE - 1 g/100mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 30 May, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part352 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Thirteen Lune Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0810101100055
|
| UPC stands for Universal Product Code. |
| UNII: | 15FIX9V2JP
SOI2LOH54Z
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 82735-200-01 | 50 mL in 1 TUBE (82735-200-01) | 30 May, 2022 | N/A | No |
| 82735-200-02 | 15 mL in 1 TUBE (82735-200-02) | 15 Jun, 2022 | N/A | No |
| 82735-200-03 | 4 mL in 1 PACKET (82735-200-03) | 15 Jun, 2022 | N/A | Yes |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose sunscreen
Product Elements:
One and done spf 40 zinc oxide zinc oxide titanium dioxide titanium dioxide water
Indications and Usage:
Uses helps prevent sunburn. if used as directed with other sun protection measures (see directions), decrease the risk of skin cancer and early skin againg caused by the sun.
Warnings:
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 ask a doctor if rash occurs. keep out of reach of children. if product is swallowed get medical help or contact a poison control center right away. keep outer carton for complete labeling information.
Dosage and Administration:
Directions apply liberally 15 minutes before sun exposure. reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. sun protection measures. spending time in the sun increased your risk of skin cancer and early skin aging. to decrease this rick, regularly use a sunscreen with a broad spectrum spf of 15 or higher and other sun protection measure including: limit time in the sun, especially from 10 a.m. - 2p.m. wear long sleeve shirts, pants, hats and sunglasses. children under 6 months: ask a doctor
Package Label Principal Display Panel:
Principal display panel 50ml relevant one + done 50ml 15ml relevant one + done spf 4ml relevant one + done sachet (sample) primary packaging artwork 15ml primary packaging artwork 4ml primary packaging artwork
Further Questions:
Questions (888) 305-2032