Sheer Daily Wear Face Protection Mineral Based Sunscreen Spf 16 Cream
FDA Label NDC 82328-0012

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rejuva Minerals Inc for the product Sheer Daily Wear Face Protection Mineral Based Sunscreen Spf 16 (NDC 82328-0012). 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 drug facts, active ingredients, purpose, uses:, warnings:, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Zinc Oxide (17.5%)

Purpose

Sunscreen

Uses:

Helps prevent sunburn if used as directed with other sun protection measures (see Directions)

  • Decreases the risk of skin cancer and early skin aging caused by the sun

Warnings:

For external use only

Do Not Use

  • on damaged or broken skin

When Using This Product

  • keep out of eyes. Rinse with water to remove

Stop Use And Ask A Doctor If

  • rash occurs

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 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 value of SPF 15 or higher and other sun protection measures including: limit time in the sun, especially from 10a.m. – 2p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses
  • use water resistant sunscreen if swimming or sweating
  • Children under 6 months of age: Ask a doctor.

Inactive Ingredients:

Water (Aqua), Caprylic/Capric Triglyceride, Helianthus Annuus (Sunflower) Oil, Cocos Nucifera (Coconut) Oil, Sorbitan Stearate, Polyglyceryl-10 Laurate, Glycerin*, Polyhydroxystearic Acid, Aloe Barbadensis Leaf Juice, Magnesium Sulfate, Gluconolactone, Triethoxycaprylylsilane, Sodium Benzoate, Santalum Album (Sandalwood) Oil, Glycerin, Xanthan Gum, Simmondsia Chinensis (Jojoba) Seed Oil*, Helianthus Annuus (Sunflower) Seed Oil*, Cocos Nucifera (Virgin Coconut) Oil*, Calcium Gluconate, Sodium Hyaluronate, Palmitoyl Tetrapeptide-7, Palmitoyl Hexapeptide-12. *Certified Organic. May Contain: Iron Oxide CI 77492, Iron Oxide CI 77491, Iron Oxide CI 77499

Questions:

Call (352) 589-0139

Package Labeling:

Bottle (Bottle)

Bottle (Bottle)

* Please review the disclaimer below.