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| Product NDC Code | 69494-014 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Fusion mineral body |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | LOTION | ||||||
| Application Number | M020 | ||||||
| Labeler Name | ISDIN Corp. | ||||||
| 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 Ingredient Zinc Oxide 12%
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 Shake well before use apply liberally 15 minutes before sun exposure Reapply: use a water-resistant sunscreen if swimming or sweating at least every 2 hours. Children under 6 months of age: Ask a doctor. 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 broad spectrum SPF value of 15 or higher and other sun protection measures including: limit your 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 Allantoin, Aloe Barbadensis Leaf Juice Powder, Bisabolol, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ceteth-20, Cetyl Alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hexylene Glycol, Isoamyl Laurate, Jojoba Esters, Lecithin, Lysolecithin, Methylpropanediol, PEG-75 Stearate, Phenoxyethanol, Phenylpropanol, Polyglyceryl-2 Dipolyhydroxystearate, Pullulan, Pyrus Malus (Apple) Fruit Extract, Sclerotium Gum, Silica, Sodium Hydroxide, Squalane, Steareth-20, Tetrasodium Glutamate Diacetate, Tocopherol, Water, Xanthan Gum
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 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.
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.Fusion Mineral Body Zinc Oxide Zinc Oxide Zinc Oxide LECITHIN, SOYBEAN POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE Hydrolyzed Jojoba Esters (Acid Form) Methylpropanediol Caprylyl Glycol Phenylpropanol Xanthan Gum Isoamyl Laurate Hexylene Glycol Tocopherol Cetyl Alcohol Ethylhexylglycerin Glycerin Silicon Dioxide Water .ALPHA.-BISABOLOL, (+)- Butyloctyl Salicylate Ceteth-20 Pullulan Squalane Steareth-20 Cyclodextrins
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.PRINCIPAL DISPLAY PANEL - 100 mL Tube Label ISDIN PHOTO Fusion Mineral BODY BROAD SPECTRUM SPF 40 Ultralight protection and hydration for all skin types 100% MINERAL SUNSCREEN 3.4 FL OZ (100 mL) PRINCIPAL DISPLAY PANEL - 100 mL Tube 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
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on damaged or broken skin
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 product is swallowed, get medical help or contact a Poison Control Center right away
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call (862) 242-8129 Monday – Friday (9 a.m. to 5 p.m. EST) or visit www.isdin.com
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 ask doctor if rash occurs
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product keep out of eyes. Rinse with water to remove
Storage and handling
Information about safe storage and handling of the drug product.Other Information Protect the product in this container from excessive heat and direct sun.
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 with water to remove Stop use and ask doctor if rash occurs Keep out of reach of children. If product is 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