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Product NDC Code | 53675-160 | ||||
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Drug Name | Island remedy all-day revitalizing moisturizer with spf 30 |
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Type | Brand | ||||
Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
Application Number | M020 | ||||
Labeler Name | Aruba Aloe Balm NV | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Titanium Dioxide 5.78% Zinc Oxide 3.74% Purpose Sunscreen
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.Directions Apply a small amount on area of skin treatment, reapply frequently if necessary. 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 value 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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Water (Aqua/Eau), Cetearyl Isononanoate, Glyceryl Stearate, Cetearyl Alcohol, Ceteareth-20, PEG-20 Glyceryl Stearate, Cetyl Palmitate, Ethylhexyl Methoxycrylene, C12-C15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Hydrogen Dimethicone, Butyloctyl Salicylate, Propylene Glycol, Argania Spinosa Kernel Oil, Tocopheryl Acetate (Vitamin E Acetate), Bisabolol, Isostearic Acid, Aluminum Hydroxide, Polyhydroxystearic Acid, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Arnica Montana Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Symphytum Officinale Leaf Extract, Achillea Millefolium Extract, Calendula Offcinalis Flower Extract, Prunus Serotina (Wild Cherry) Bark Extract, Eugenia Caryophyllus (Clove) Flower Extract, Equisetum Hiemale Extract, Cymbopogon Schoenanthus Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Ascorbic Acid (Vitamin C).
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.Uses • Helps prevent sunburn • Higher SPF gives more sunburn protection.
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.Island Remedy All-day Revitalizing Moisturizer with SPF 30 TITANIUM DIOXIDE, ZINC OXIDE ALOE VERA LEAF WATER CETEARYL ISONONANOATE GLYCERYL MONOSTEARATE CETOSTEARYL ALCOHOL POLYOXYL 20 CETOSTEARYL ETHER PEG-20 GLYCERYL STEARATE CETYL PALMITATE ETHYLHEXYL METHOXYCRYLENE ALKYL (C12-15) BENZOATE MEDIUM-CHAIN TRIGLYCERIDES BUTYLOCTYL SALICYLATE PROPYLENE GLYCOL ARGAN OIL .ALPHA.-TOCOPHEROL ACETATE LEVOMENOL ISOSTEARIC ACID ALUMINUM HYDROXIDE POLYHYDROXYSTEARIC ACID (2300 MW) PHENOXYETHANOL CAPRYLYL GLYCOL CHLORPHENESIN ARNICA MONTANA FLOWER CHAMOMILE COMFREY LEAF ACHILLEA MILLEFOLIUM CALENDULA OFFICINALIS FLOWER PRUNUS SEROTINA BARK CLOVE EQUISETUM HYEMALE CYMBOPOGON SCHOENANTHUS TOP JOJOBA OIL ASCORBIC ACID TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC CATION
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.Package Labeling: Inner Package Labeling: Outer Package Labeling: Inner Label Outer Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
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.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and consult a doctor if rash or irritation develops and lasts.
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 Avoid contact with eyes, rinse with water to remove. Stop use and consult 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.
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