Nia 24 Spf 30
Homosalate, Octisalate, Avobenzone, Octocrylene
Niadyne Inc
Human Otc Drug
NDC 43115-123Nia 24 Spf 30 also known as Homosalate, Octisalate, Avobenzone, Octocrylene is a human otc drug labeled by 'Niadyne Inc'. National Drug Code (NDC) number for Nia 24 Spf 30 is 43115-123. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Nia 24 Spf 30 drug includes Avobenzone - 30 mg/mL Homosalate - 75 mg/mL Octisalate - 50 mg/mL Octocrylene - 26 mg/mL . The currest status of Nia 24 Spf 30 drug is Active.
Drug Information:
| Drug NDC: | 43115-123 |
| 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: | Nia 24 Spf 30 |
| 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, Octisalate, Avobenzone, Octocrylene |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Niadyne Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Lotion |
| 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: | AVOBENZONE - 30 mg/mL
HOMOSALATE - 75 mg/mL
OCTISALATE - 50 mg/mL
OCTOCRYLENE - 26 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 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: | 09 Jun, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 20 Jun, 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, 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: | |
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| UNII: | |
| 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 |
|---|
| 43115-123-01 | 1 TUBE in 1 PACKAGE (43115-123-01) / 30 mL in 1 TUBE | 19 Dec, 2017 | N/A | No |
| 43115-123-02 | 1 TUBE in 1 PACKAGE (43115-123-02) / 75 mL in 1 TUBE | 19 Dec, 2017 | 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:
Uses - for prevention of sunburn
Product Elements:
Nia 24 spf 30 homosalate, octisalate, avobenzone, octocrylene water dipropylene glycol myristyl nicotinate polyester-8 (1400 mw, cyanodiphenylpropenoyl capped) cyclomethicone glyceryl monostearate panthenol potassium cetyl phosphate butylene glycol mangifera indica seed butter hydrogenated palm glycerides glycyrrhizinate dipotassium soybean ceramide 2 ceramide 3 lycium chinense fruit lowbush blueberry arctostaphylos uva-ursi leaf peg-100 stearate sodium polyacrylate (2500000 mw) isohexadecane sorbitan sesquioleate polysorbate 80 cetyl alcohol xanthan gum carbomer interpolymer type a (allyl sucrose crosslinked) potassium hydroxide edetate disodium phenoxyethanol caprylyl glycol nutmeg homosalate homosalate octisalate octisalate avobenzone avobenzone octocrylene octocrylene
Warnings:
Warnings for external use only.
When Using:
When using this product, keep out of eyes. rinse with water to remove.
Dosage and Administration:
Directions - apply a dime sized amount in the morning on cleansed face and neck or over a moisturizer. - reapply as needed or after towel drying, swimming or perspiring.
Stop Use:
Stop use and ask a doctor if rash or irritation develops and lasts.
Description:
Prevention now starts from within. the benefits of nia 24tm help to prevent, repair and fight the visible signs of sun damage. skin cancer foundation facts*: - in our lifetime, 1 in 5 americans will be victims of skin cancer. - more than 90% of all skin cancers are preventable--- caused by sun exposure. - the risk of melanoma has doubled in the past decade. it is responsible for 75% of all skin cancer-related deaths. *these facts have been provided by the skin cancer foundation. - improve the appearance of sun damage, hyperpigmentation and brown spots. - reduce the appearance of fine lines and wrinkle. - improve skin tone, texture and firmness. - see stronger skin with a better self-defense against visible signs of sun damage and moisture loss. physician recommended allergy tested fragrace, color and dye free non-comedogenic.
Package Label Principal Display Panel:
Nia 24 niacin-powered skin therapy sun damage prevention uva/uvb sunscreen micro nutrient deliver: niachi spf 30 pa +++ 5% pro-niacin patented formula for moderate to severs sun demage
Active ingredients: homosalate (7.5%), octisalate (5.0%), avobenzone (3.0%), octocrylene (2.6%). uses - for prevention of sunburn warnings for external use only.when using this product, keep out of eyes. rinse with water to remove.stop use and ask a doctor if rash or irritation develops and lasts.for children 6 months of age or under , consult a doctor prior to use.keep out of reach of children.if swallowed, get medical help or contact a poison control center right away.uv exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. it is important to decrease uv exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen. e 30ml/1 fluid oz. covered by us patents 6337065, 6552050, 6464992 niadyne, inc., raieigh, nc 27609/biorus sprl, 2 rue rene descartes, b-7000 mons, belgium 866-niadyne (642-3963) www.nia24.com made in the usa 12m
Predamage postdamage undamage nia24 niacin powered skin therapy for moderate severe sun damage pa +++ sun damage prevention uva(aging)/uvb(burning) sunscreen micronutrient delivery: niacin spf 30 pa+++ 5% pro-niacin patented formula a lightweight, non-greasy lotion with spf 30 and pa+++ that absorbs instantly into skin. formulated with powerful ingredients that provide uva (aging rays) and uvb (burning rays) protection from sun damage while helping to repair the skin barrier. - continuous, deep delivery of pro-niacin strengthens the skin barrier. - pro-niacin is clinically shown to visibly improve skin tone, texture and hyperpigmentation. - broad spectrum protection (uva/uvb) with the highest pa rating, helps defend skin against free radical attack that weakens and ages the skin. - mango butter provides balanced moisturization without leaving excess. - ceramides promote healthy, vibrant skin. - antioxidants protect skin from oxidative stress. recommended skin cancer foundation daily use * these facts have been provided by the skin cancer foundation e 75ml/2.5 fluid oz 0141a1 exp:01/2013 8 51203 00073 7
Covered by us patents 6337065, 6552050, 6464992 niadyne, inc., raieigh, nc 27609/biorus sprl, 2 rue rene descartes, b-7000 mons, belgium for all consumer inquiries, please call 866-niadyne (642-3963) www.nia24.com made in the usa 12m nia24 nia24 nia24 nia24 nia24 nia24 nia24 nia24 nia24
Nia24 tube 1
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Nia24 outer 1