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| Product NDC Code | 72839-114 | ||||||||||
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| Drug Name | Coral isle spf 50 mineral sunscreen |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||
| Dosage Form | LOTION | ||||||||||
| Application Number | M020 | ||||||||||
| Labeler Name | Derma Care Research Labs, LLC | ||||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Titanium Dioxide 4.4%, Zinc Oxide 4%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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 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: 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.
Purpose
Information about the drug product’s indications for use.Purpose Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Coral Isle SPF 50 Mineral Sunscreen Titanium Dioxide, Zinc Oxide ETHYLHEXYL PALMITATE EDETATE DISODIUM TITANIUM DIOXIDE TITANIUM DIOXIDE ALKYL (C12-15) BENZOATE ALUMINUM STARCH OCTENYLSUCCINATE STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) GLYCERIN ZINC OXIDE ZINC OXIDE ETHYLHEXYLGLYCERIN PHENOXYETHANOL CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) SORBITAN OLIVATE DIMETHICONE 200 HYDRATED SILICA WATER HYDROGEN DIMETHICONE (20 CST) SODIUM CHLORIDE ROSEMARY VITIS VINIFERA SEED GREEN TEA LEAF ALUMINUM OXIDE ALOE VERA LEAF MENTHA PIPERITA LEAF CUCUMBER POMEGRANATE JUICE RICE BRAN, DEFATTED PROPANEDIOL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Label Coral Isle SPF 50 Mineral Sunscreen, 2 oz, NDC 72839-114-02 Coral Isle Baby SPF 50 Mineral, 2 oz, NDC 72839-114-12 Coral Isle SPF 50 Mineral Sunscreen, 6 oz, NDC 72839-114-06 Coral Isle SPF 50 Baby Mineral Sunscreen, 6 oz, NDC 72839-114-16 LABEL LABEL Label Label LABEL LABEL
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep Out of Reach of Children. If swallowed, get medical help or contact a Poison Control Center right away.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API