Nia24 Sun Damage Defense Broad Spectrum Uva/uvb Sunscreen
FDA Label NDC 43115-102

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Niadyne Inc for the product Nia24 Sun Damage Defense Broad Spectrum Uva/uvb Sunscreen (NDC 43115-102). 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 active ingredients, purpose, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Avobenzone 3%
Homosalate 7.5%
Octisalate 5%
Octocrylene 2.6%

Purpose

Sunscreen

Warnings

  • For external use only.
  • Do not use on damaged or broken skin.
  • Stop use and ask a doctor if rash occurs.
  • When using this product, keep out of eyes. Rinse well with water to remove.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water-resistant sunscreen if swimming or sweating.
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen witha broad spectrum SPF 15 or higher and other sun protection measures, including:
    - Limit time in the sun, especially from 10 am – 2 pm.
    - Wear long-sleeve shirts, pants, hats, and sunglasses.
  • Children under 6 months of age: Ask a doctor.

Other Information

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Aqua (Water, Eau), Dipropylene Glycol, Myristyl Nicotinate, Polyester-8, Caprylyl Methicone, Cyclopentasiloxane, Glycine Soja (Soybean) Seed Extract, Ceramide NG, Ceramide NP, Lycium Chinense Fruit Extract, Vaccinum Angustifolium (Blueberry) Fruit Extract Arctostaphylos Uva Ursi Leaf Extract, Mangifera Indica (Mango) Seed Butter, Dipotassium Glycyrrhizate, Tocopheryl Acetate, Sorbitan Sesquioleate, Cetyl Alcohol, Methyl Glucose Sesquistearate, Potassium Cetyl Phosphate, Hydrogenated Palm Glycerides, Butylene Glycol, Caprylyl Glycol, Sodium Acrylate/Sodium Acryloyidimethyl Taurate Copolymer, Isohexadecane, Polysorbate 80, Fragrance (Parfum),
Polyacrylate-15, Polyacrylate -17, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Phenoxyethanol, Chlorphenesin, Xanthan Gum, Cyclohexasiloxane, Potassium Hydroxide, C11-15 Pareth-7, C11-15 Pareth-40, Sodium Laureth-12 Sulfate, Disodium Lauryl Sulfosuccinate, Sorbitan Oleate, Potassium Sorbate, Hexylene Glycol, Hydroxyisohexyl 3-cyclohexene carboxaldehyde

Package Label.Principal Display Panel

4001523405_sundamagedefense_spf30_carton_fnl_8.23.18 (4001523405 Sundamagedefense Spf30 Carton Fnl 8.23.18)

4001523405_sundamagedefense_spf30_carton_fnl_8.23.18 (4001523405 Sundamagedefense Spf30 Carton Fnl 8.23.18)

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