Nia 24 Spf 30

Nia 24 Spf 30
SPL v10
SPL
SPL Set ID e5c9d56f-48b4-4f0e-add6-f73268755b16
Route
TOPICAL
Published
Effective Date 2011-04-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (75 mg) Octisalate (50 mg) Avobenzone (30 mg) Octocrylene (26 mg)
Inactive Ingredients
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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-06-09

Description

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


Medication Information

Warnings and Precautions

Warnings  For external use only.

Indications and Usage

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

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.

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.

Section 42232-9

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.

Section 50565-1

Keep out of reach of children.

Section 50566-9

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

Section 50567-7

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

Section 50569-3

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

Section 51727-6

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.

Section 51945-4

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

Section 55105-1

Uses  - for prevention of sunburn

Section 55106-9

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








Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

Warnings  For external use only.

Description (34089-3)

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.

Section 42232-9 (42232-9)

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.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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

Section 50569-3 (50569-3)

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

Section 51727-6 (51727-6)

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.

Section 51945-4 (51945-4)

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

Section 55105-1 (55105-1)

Uses  - for prevention of sunburn

Section 55106-9 (55106-9)

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








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