Active Ingredients
Titanium Dioxide (6.0%)
Zinc Oxide (6.0%)
Coralsafe Broad Spectrum Spf30 Cream
FDA Label NDC 71221-333
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 for the product Coralsafe Broad Spectrum Spf30 (NDC 71221-333). 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:
• Limiting time in the sun, especially from 10 am - 2 pm. • Wearing long-sleeve shirts, pants, hats and sunglasses • Children under 6 months: Ask a doctor
Inactive Ingredients:
Aloe Barbadensis (Aloe Vera) Juice, Aqua (Deionized Water), Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Extract, Cocos Nucifera (Coconut) Oil, Dehydroxanthan Gum, Gluconolactone, Glycerin, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Oil, Lecithin, Mangifera Indica (Mango) Butter, Sodium Benzoate, Sodium Laurylglucosides Hydroxypropylsulfonate, Styrene/Acrylates Copolymer, Tocopheryl (Vitamin-E), Xanthan Gum.
Other Information:
Protect this product from excessive heat and direct sun.
Package Labeling:
Label (Label)
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