Active Ingredients
Titanium Dioxide (6.0%)
Zinc Oxide (6.0%)
Coral Safe Spf-30 Broad Spectrum Sunscreen Cream
FDA Label NDC 71221-791
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Elements Brands, Inc. for the product Coral Safe Spf-30 Broad Spectrum Sunscreen (NDC 71221-791). 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, 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 • 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 occurs.
Keep Out Of Reach Of Children.
If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions:
• Apply liberally 15 minutes before sun exposure • 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 this risk, regularly use a sunscreen with a Broad Spectrum SPF of 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.
•For children under 6 months: consult a physician.
Inactive Ingredients:
Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl/Capryl Glucoside, Citrullus Lanatus (Watermelon) Extract, Daucus Carota Sativa (Carrot) Seed Extract, Gluconolactone, Glycerin, Glyceryl Caprylate, Glyceryl Stearate Citrate,Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Lecithin, Leuconostoc/Radish Root Ferment Filtrate, Lonicera Japonica (Honeysuckle) Flower Extract, Mangifera Indica (Mango) Seed Butter, Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Populus Tremuloides Bark Extract, Stearic Acid, Tocopherol (Vitamin E), Xanthan Gum.
Other Information:
Protect this product from excessive heat and direct sun.
Package Labeling:
Label (Label)
* Please review the disclaimer below.
