NIA 24 SPF 30- homosalate, octisalate, avobenzone, octocrylene lotion

NIA 24 SPF 30 by

Drug Labeling and Warnings

NIA 24 SPF 30 by is a Otc medication manufactured, distributed, or labeled by Niadyne Inc, Englewood Lab, Inc., Englewood Lab Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                                 Purpose
Homosalate 7.5%.................................Sunscreen
Octisalate 5.0%...................................Sunscreen
Avobenzone 3.0%................................Sunscreen
Octocrylene 2.6%................................Sunscreen

PURPOSE

Uses  - for prevention of sunburn

WARNINGS

Warnings  For external use only.

WHEN USING

When using this product, keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor if rash or irritation develops and lasts.

ASK DOCTOR

For children 6 months of age or under , consult a doctor prior to use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OTHER SAFETY INFORMATION

If swallowed, get medical help or contact a poison control center right away.

PRECAUTIONS

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.

DOSAGE & 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.

INACTIVE INGREDIENT

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.

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.

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

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	26 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
MYRISTYL NICOTINATE (UNII: 8QWM6I035C)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
CYCLOMETHICONE (UNII: NMQ347994Z)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PANTHENOL (UNII: WV9CM0O67Z)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
SOYBEAN (UNII: L7HT8F1ZOD)
CERAMIDE 2 (UNII: C04977SRJ5)
CERAMIDE 3 (UNII: 4370DF050B)
LYCIUM CHINENSE FRUIT (UNII: TG711Q7A1Q)
LOWBUSH BLUEBERRY (UNII: G90PX41VP0)
ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)
PEG-100 STEARATE (UNII: YD01N1999R)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
ISOHEXADECANE (UNII: 918X1OUF1E)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CETYL ALCOHOL (UNII: 936JST6JCN)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
NUTMEG (UNII: AEE24M3MQ9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43115-123-01	1 in 1 PACKAGE	12/19/2017
1		30 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 43115-123-02	1 in 1 PACKAGE	12/19/2017
2		75 mL in 1 TUBE; Type 0: Not a Combination Product

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	Business Operations
Englewood Lab, Inc.		080366903	manufacture(43115-123)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab Korea Co., Ltd.		690104005	manufacture(43115-123)