The following Structured Product Label (SPL) was submitted to the FDA by Niadyne Inc for the product Nia 24 Spf 30 (NDC 43115-123). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - when using, otc - stop use, otc - ask doctor, otc - keep out of reach of children, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredients Purpose
Homosalate 7.5%.................................Sunscreen
Octisalate 5.0%...................................Sunscreen
Avobenzone 3.0%................................Sunscreen
Octocrylene 2.6%................................Sunscreen
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.
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.
Inactive Ingredients
Water (Aqua/Eau), Dipropylene Glycol, Myristyl Nicotinate, Polyester-8, Caprylyl Methicone, Cyclomethicone, Glyceryl Stearate, Polyacrylate-15, Panthenol, Potassium Cetyl Phosphate, Butylene Glycol, Mangifera Indica (Mango) Seed Butter, Methyl Glucose Sesquistearate, Hydrogenated Palm Glycerides, Polyacrylate-17, Dipotassium Glycyrrhizate, Glycine Soja (Soybean) Seed Extract, Ceramide 2, Ceramide 3, Lycium Chinensis Fruit Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Arctostaphylos Uva Ursi Leaf Extract, PEG-100 Stearate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Sorbitan Sesquioleate, Polysorbate 80, Cetyl Alcohol, Tocopheryl Acetate, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Potassium Hydroxide, Disodium EDTA, Phenoxyethanol, Caprylyl Glycol, Myristica Fragrans (Nutmeg) Kernel Extract.
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.
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 (Nia24a)
Nia24 Tube 2 (Nia24b)
Nia24 Outer 1 (Nia24c)
* Please review the disclaimer below.
