Active Ingredients
Titanium Dioxide 4.4%, Zinc Oxide 4%
Coral Isle Spf 50 Mineral Sunscreen Lotion
FDA Label NDC 72839-114
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Derma Care Research Labs, Llc for the product Coral Isle Spf 50 Mineral Sunscreen (NDC 72839-114). 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, keep out of reach of children., directions, inactive ingredients, label, 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 eyes 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:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- limit time in the sun, especially from 10 am to 2 pm
- wear long-sleeved shirts, pants, hats, and sunglasses.
- Children under 6 months: ask a doctor.
Sun protection measures: spending time n the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measure including:
Inactive Ingredients
Water, ethylhexyl palmitate, C12-15 alkyl benzoate, styrene/acrylates copolymer, glycerin, sorbitan olivate, cetyl PEG/PPG-10/1 dimethicone, dimethicone, aluminum starch octenylsuccinate, sodium chloride, silica, aloe barbadensis leaf extract, cucumis sativus (cucumber) fruit extract, mentha piperita (peppermint) leaf extract, punica granatum fruit juice, oryza sativa (rice) bran water, rosmarinus officinalis (rosemary) leaf extract, vitis vinifera (grade) seed extract, camellia sinensis leaf extract, ethylhexylglycerin, propanediol, disodium EDTA, phenoxyethanol, alumina, hydrogen dimethicone
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