Super Lysine Plus Strawberry Lip Treatment
Octinoxate And Oxybenzone
Quantum, Inc.
Human Otc Drug
NDC 70084-240Super Lysine Plus Strawberry Lip Treatment also known as Octinoxate And Oxybenzone is a human otc drug labeled by 'Quantum, Inc.'. National Drug Code (NDC) number for Super Lysine Plus Strawberry Lip Treatment is 70084-240. This drug is available in dosage form of Lipstick. The names of the active, medicinal ingredients in Super Lysine Plus Strawberry Lip Treatment drug includes Octinoxate - 70 mg/g Oxybenzone - 50 mg/g . The currest status of Super Lysine Plus Strawberry Lip Treatment drug is Active.
Drug Information:
| Drug NDC: | 70084-240 |
| 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: | Super Lysine Plus Strawberry Lip Treatment |
| 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: | Octinoxate And Oxybenzone |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Quantum, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Lipstick |
| 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: | OCTINOXATE - 70 mg/g
OXYBENZONE - 50 mg/g
|
| 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: | 02 Apr, 2001 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 Dec, 2025 |
| 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, 2024 |
| 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: | Quantum, 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: | 0046985000062
|
| UPC stands for Universal Product Code. |
| UNII: | 4Y5P7MUD51
95OOS7VE0Y
|
| 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 |
|---|
| 70084-240-01 | 5 g in 1 CYLINDER (70084-240-01) | 02 Apr, 2001 | 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:
Active ingredients purpose octinoxate 7.0% sunscreen oxybenzone (benzophenone-3) 5.0% sunscreen
Product Elements:
Super lysine plus strawberry lip treatment octinoxate and oxybenzone octinoxate octinoxate oxybenzone oxybenzone yellow wax calendula officinalis flower echinacea purpurea whole benzoin resin goldenseal lysine hydrochloride tea tree oil melaleuca cajuputi leaf oil propolis wax vitamin a palmitate safflower cholecalciferol carnauba wax water castor oil jojoba oil .alpha.-tocopherol acetate tocopherol brownish-white
Indications and Usage:
Uses helps protect against sunburn and chapped lips.
Warnings:
Warnings skin cancer/skin aging alert: spending time in the sun increases your risk of skin cancer and early skin aging. this product has been shown only to help prevent sunburn, not skin cancer or early skin aging. for external use only. do not use on damaged or broken skin. stop use and consult a doctor if rash occurs. avoid contact with eyes. if in eyes, rinse with warm water to remove. keep out of reach of children. if swallowed, get medical help or contact a poison control center.
Do Not Use:
Warnings skin cancer/skin aging alert: spending time in the sun increases your risk of skin cancer and early skin aging. this product has been shown only to help prevent sunburn, not skin cancer or early skin aging. for external use only. do not use on damaged or broken skin. stop use and consult a doctor if rash occurs. avoid contact with eyes. if in eyes, rinse with warm water to remove. keep out of reach of children. if swallowed, get medical help or contact a poison control center.
Dosage and Administration:
Directions apply liberally 15 minutes before sun exposure. use a water resistant sunscreen if swimming or sweating. reapply at least every 2 hours. children under 6 months: ask a doctor.
Stop Use:
Stop use and consult a doctor if rash occurs.
Package Label Principal Display Panel:
Principal display panel - 5 g cylinder blister pack quantum ® health peel label for drug facts superlysine + ® strawberry flavor lip treatment & protectant net wt 5g / .17 oz spf 21 sunscreen principal display panel - 5 g cylinder blister pack