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Name:Nia 24 Spf 30
Manufacturer:Niadyne Inc
Category:Over-the-counter (OTC) Marketed Drugs


NIA 24 SPF 30

NIA 24 SPF 30  - homosalate, octisalate, avobenzone and octocrylene lotion 
Niadyne Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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NIA 24 SPF 30

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

NIA24 Tube 2

NIA24 Outer 1


NIA 24 SPF 30 
homosalate, octisalate, avobenzone, octocrylene lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43115-123
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE (HOMOSALATE) HOMOSALATE 7.5 mL  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE 5.0 mL  in 100 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE 3.0 mL  in 100 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 2.6 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
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 CHINENSIS 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 (55000 MPA.S))  
POTASSIUM HYDROXIDE  
EDETATE DISODIUM  
PHENOXYETHANOL  
CAPRYLYL GLYCOL  
NUTMEG  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43115-123-01 1 TUBE ( TUBE) in 1 PACKAGE contains a TUBE
1 30 mL in 1 TUBE This package is contained within the PACKAGE (43115-123-01)
2 NDC:43115-123-02 1 TUBE ( TUBE) in 1 PACKAGE contains a TUBE
2 75 mL in 1 TUBE This package is contained within the PACKAGE (43115-123-02)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 06/09/2011

Labeler - Niadyne Inc (113220482)
Establishment
Name Address ID/FEI Operations
Englewood Lab, LLC 172198223 manufacture

Revised: 06/2011 Niadyne Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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