Active Ingredients
Zinc Oxide 14.00 %
Titanium Dioxide 6.00 %
Project Reef Mineral Sunscreen Spf-50 Lotion
FDA Label NDC 81637-299
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 Mineral Sunscreen Spf-50 (NDC 81637-299). 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, uses:, warnings:, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Uses:
• Helps prevent sunburn. • higher SPF gives more sunburn protection
• 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 not intended for ingestion.
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
• Children under 6 months of age: ask a doctor.
• Reapply at least every 2 hours
• Reapply as needed or after towel drying, swimming, or sweating.
• 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 the risk, regularly use a sunscreen with broad spectrum SPF 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, Lavandula Angustifolia (Lavender) Oil, Polyhydroxystearic Acid, *Punica Granatum (Pomegranate) Extract, Rubus Idaeus (Raspberry) Extract, Stearic Acid, Tridecyl Salicylate, Xanthan Gum, Zemea (Corn) Propanediol.
*Denotes Organic Ingredient
Questions?
Call 800 914 0146
Package Labeling:
Label02 (Label02)
* Please review the disclaimer below.
