Protect Prevent Daily Mineral Sunscreen Broad Spectrum Spf30 Cream
FDA Label NDC 80971-102

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Norwex Usa, Inc. for the product Protect Prevent Daily Mineral Sunscreen Broad Spectrum Spf30 (NDC 80971-102). 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 actives/medicinal ingredients:% w/w- p/p:, purpose, uses, warnings, when using this product, stop use and consult a doctor if, keep out of reach of children., do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Actives/Medicinal Ingredients:% W/W- P/P:

Titanium Dioxide ............ 2.88%
Zinc Oxide........................ 6.80%

Purpose

Sunscreen

Uses

Helps prevent sunburn.

Warnings

For external use only.

When Using This Product

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop Use And Consult A Doctor If

rash occurs.

Keep Out Of Reach Of Children.

If swallowed, call a poison control centre or get medical help right away.

Do Not Use

on broken skin.

Directions

  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Reapply after 40 minutes of swimming or sweating.
  • Reapply immediately after towel drying.
  • Children under 6 months of age: Ask a doctor.
  • 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 with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. – 2 p.m.; and wear long-sleeved shirts, pants, hats and sunglasses.
  • Store in a cool dry place.
  • Do not use if safety seal is broken.
  • May stain some fabric.
  • Protect the product in this container from excessive heat and direct sun.

Non-Medicinal/Other Ingredients:

Water, Isoamyl Laurate, Caprylic/ Capric Triglyceride, Butyloctyl Salicylate, Glycerin, C12-15 Alkyl Benzoate, Arachidyl Alcohol, Polyglyceryl-10 Laurate, Cetearyl Olivate, Lactobacillus Ferment, Sorbitan Olivate, Argania Spinosa (Argan) Kernel Oil, Fructose, Linum Usitatissimum (Flaxseed) Seed Oil*, Ribes Nigrum (Black Currant) Seed Oil*, Rubus Chamaemorus (Cloudberry) Seed Oil*, Withania Somnifera (Ashwagandha) Root Extract, Sambucus Nigra (Elderberry) Seed Oil*, Dipotassium Glycyrrhizate, Vaccinium Vitis-Idaea (Lingonberry) Seed Oil*, Hippophae Rhamnoides (Sea Buckthorn) Fruit Extract, Betula Alba (Birch Sap Juice) Bark Extract, Ocimum Basilicum (Basil) Oil, Tocopheryl Acetate, Lavandula Angustifolia (Lavender) Oil, Pelargonium Graveolens (Geranium) Flower Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Limon (Lemon) Peel Oil, Hydroxyacetophenone, Biosaccharide Gum-4, Stearic Acid, Bisabolol, Arachidyl Glucoside, Behenyl Alcohol, Polyhydroxystearic Acid, Cetyl Alcohol, Stearyl Alcohol, Hydroxyethyl Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Cellulose Gum, Xanthan Gum, 1,2-Hexanediol, Citric Acid, Alumina, Microcrystalline Cellulose, Styrene/Acrylates Copolymer, Potassium Sorbate, Limonene, Linalool, Citral. *Organic Ingredients/ Ingrédients organiques.

* Please review the disclaimer below.