Dr. C. Tuna Sun Protector Lip Balm Spf 15
Homosalate, Octinoxate
Farmasi Us Llc
Human Otc Drug
NDC 74690-030Dr. C. Tuna Sun Protector Lip Balm Spf 15 also known as Homosalate, Octinoxate is a human otc drug labeled by 'Farmasi Us Llc'. National Drug Code (NDC) number for Dr. C. Tuna Sun Protector Lip Balm Spf 15 is 74690-030. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Dr. C. Tuna Sun Protector Lip Balm Spf 15 drug includes Homosalate - 44.5 mg/mL Octinoxate - 34.5 mg/mL . The currest status of Dr. C. Tuna Sun Protector Lip Balm Spf 15 drug is Active.
Drug Information:
| Drug NDC: | 74690-030 |
| 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: | Dr. C. Tuna Sun Protector Lip Balm Spf 15 |
| 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: | Homosalate, Octinoxate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Farmasi Us Llc |
| 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: | HOMOSALATE - 44.5 mg/mL
OCTINOXATE - 34.5 mg/mL
|
| 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 NOT 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: | 05 Jan, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 04 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: | FARMASI US LLC
|
| 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. |
| UNII: | V06SV4M95S
4Y5P7MUD51
|
| 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 |
|---|
| 74690-030-00 | 1 BOTTLE in 1 BOX (74690-030-00) / 15 mL in 1 BOTTLE | 05 Jan, 2022 | N/A | No |
| 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:
Dr. c. tuna sun protector lip balm spf 15 homosalate, octinoxate medium-chain triglycerides synthetic beeswax ceresin cetyl alcohol di-c12-15 alkyl fumarate silicon dioxide .alpha.-tocopherol acetate homosalate homosalate octinoxate octinoxate
Indications and Usage:
Uses: helps prevent sunburn.
Warnings:
Warnings: for external use only. do not use on damaged or broken skin. undefined 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 swallowed, get medical help or contact a poison control center right away. this product has been shown only to help prevent sunburn, not skin cancer or early skin aging. protects against uvb and uva rays. this product does not provide 100% protection. use physical protection (hat, t-shirt, glasses, etc.) avoid long periods of sun exposure even if you are using sun protection. keep babies and young children out of direct sunlight. the excessive sun exposure is a major health risk, discontinue use if signs of irritation or rash occur. aovid contact with eyes, may cause irritation.
Do Not Use:
Warnings: for external use only. do not use on damaged or broken skin. undefined 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 swallowed, get medical help or contact a poison control center right away. this product has been shown only to help prevent sunburn, not skin cancer or early skin aging. protects against uvb and uva rays. this product does not provide 100% protection. use physical protection (hat, t-shirt, glasses, etc.) avoid long periods of sun exposure even if you are using sun protection. keep babies and young children out of direct sunlight. the excessive sun exposure is a major health risk, discontinue use if signs of irritation or rash occur. aovid contact with eyes, may cause irritation.
When Using:
Undefined keep out of eyes. rinse with water to remove.
Dosage and Administration:
Directions: apply liberally 15 minutes before sun exposure - reapply at least every two hours. apply morning and night, and as often as needed during the day. reapply frequently on sun-centric days, and adventures. sun protection measures: children under 6 months of age: ask a doctor. apply before sun exposure. to maintain protection, apply frequently, especially after sweating, swimming or drying off. apply sufficient amount to the skin.
Stop Use:
Stop use and ask a doctor if rash occurs.
Package Label Principal Display Panel:
Package labeling: dr. c. tuna sun protector lip balm spf 15, 15ml/0.5fl.oz label01
Further Questions:
Questions or comments? info@farmasius.com (833) 432-7627 monday - friday (9 a.m. -9 p.m. est)