Label: NIA 24 SPF 30- homosalate, octisalate, avobenzone, octocrylene lotion
- NDC Code(s): 43115-123-01, 43115-123-02
- Packager: Niadyne Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 12, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- WHEN USING
- STOP USE
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- PRECAUTIONS
- DOSAGE & ADMINISTRATION
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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.
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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.
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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
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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
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INGREDIENTS AND APPEARANCE
NIA 24 SPF 30
homosalate, octisalate, avobenzone, octocrylene lotionProduct 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 Drug M020 06/09/2011 Labeler - Niadyne Inc (113220482) Establishment Name Address ID/FEI Business Operations Englewood Lab, Inc. 172198223 manufacture(43115-123) Establishment Name Address ID/FEI Business Operations Englewood Lab Korea Co., Ltd. 690104005 manufacture(43115-123)