Nia24 Sun Damage Defense Broad Spectrum 100 Percent Mineral Sunscreen
FDA Label NDC 43115-101

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 100 Percent Mineral Sunscreen (NDC 43115-101). 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

TITANIUM DIOXIDE 7.064%

ZINC OXIDE 14.00%

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.
  • Non-water resistant product.
  • 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

Nicotinate, Octyldodecyl Neopentanoate, Neopentyl Glycol Diheptanoate, Aluminum Starch Octenylsuccinate, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Stearic Acid, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Cetyl Alcohol, Magnesium Sulfate, Dimethiconol, Polysilicone-11, Caprylyl Glycol, Bisabolol, Tocopheryl Acetate, Aluminum Hydroxide, Alumina,
Isostearic Acid, Lecithin, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Benzotriazolyl Dodecyl p-Cresol, Disodium EDTA, Fragrance (Parfum)

Package Label.Principal Display Panel

4001653404_sundamagemineral_spf30_75ml_carton_fnl_8.28.18 (4001653404 Sundamagemineral Spf30 75ml Carton Fnl 8.28.18)

4001653404_sundamagemineral_spf30_75ml_carton_fnl_8.28.18 (4001653404 Sundamagemineral Spf30 75ml Carton Fnl 8.28.18)

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