Project Reef Spf-30 Mineral Sunscreen Cream
FDA Label NDC 81637-139

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Project Reef Llc for the product Project Reef Spf-30 Mineral Sunscreen (NDC 81637-139). 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 14.00%

Purpose

Sunscreen

Uses:

  • Helps prevent sunburn
  • higher SPF gives more sunburn protection
  • retains SPF after 80 minutes of swimming or sweating
  • 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 or irritation develops and lasts.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Directions:

  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor
  • Reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying 
  • 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 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.
  • Wear long- sleeved shirts, pants, hats, and sunglasses

Other Information:

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

Inactive Ingredients:

Algae Extract, *Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Benzyl Alcohol, *Butyrospermum Parkii (Shea) Butter, *Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Citric Acid, Citrus Aurantium Dulcis (Orange) Oil, *Cocos Nucifera (Coconut) Oil, Decyl Glucoside, Dehydroacetic Acid, Ethyl Vanillin, Fucus Vesiculosus (Seaweed) Extract, *Glycerin, Glyceryl Stearate, Helianthus Annuus, * Hippophae Rhamnoides (Sea Buckthorn) Oil, Hydroxyethylcellulose, Polyhydroxystearic Acid, *Punica Granatum (Pomegranate) Extract, Rubus Idaeus (Raspberry) Extract, Stearic Acid, Tridecyl Salicylate, Xanthan Gum, Zemea (Corn) Propanediol.

Questions?

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