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Product NDC Code | 72085-151 | ||||
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Drug Name | Scout spf-50 |
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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 | M017 | ||||
Labeler Name | MJ Products Association, LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Zinc Oxide 17.00% Titanium Dioxide 6.00% 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 liberally 15 minutes before sun exposure. REAPPLY: Al least every two-hours. Immediately after swimming, sweating or towel drying. : Spending time in the sun increases your risk of skin cancer and early skin aging. To decreases this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: SUN PROTECTION MEASURES Limit time in the sun, especially between 10am and 2pm. Wear long sleeve shirts, pants hats and sunglasses. For children under 6 months, consult a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.OTHER INGREDIENTS Acrylamide/Sodium Acryloyldimethyltaurate Copolymer, Allantoin, Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Extract, Cetearyl Olivate, Citric Acid, Citrullus Lanatus (Watermelon) Extract, Cocamidopropyl Betaine, Cocos Nucifera (Coconut) Oil, Cymbopogon Nardus (Citronella) Oil, Dimethicone, Ethylhexyl Palmitate, Glycerin, Glyceryl Stearate, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Oil, Isohexadecane, Laminaria (Algae) Extract, Lecithin, Mentha Piperita (Peppermint) Oil, Niacin, Parfum (Fragrance), Petrolatum, Polysorbate-20, Polysorbate-80, Simmondsia Chinensis (Jojoba) Oil, Sorbitan Olivate, Styrene/Acrylates Copolymer, Thuja Occidentalis (Cedar) Leaf Oil, Tocopherol Acetate (Vitamin E), Vitis Vinifera (grape) Seed Extract, Xanthan Gum, Zemea (Corn) Propanediol.
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.Scout SPF-50 Zinc Oxide, Titanium Dioxide ACRYLAMIDE ALLANTOIN WATER BUTYLOCTYL SALICYLATE SHEA BUTTER GREEN TEA LEAF CETEARYL OLIVATE CITRIC ACID MONOHYDRATE COCAMIDOPROPYL BETAINE COCONUT OIL CITRONELLA OIL DIMETHICONE ETHYLHEXYL PALMITATE GLYCERIN GLYCERYL MONOSTEARATE SOYBEAN OIL ISOHEXADECANE PEPPERMINT OIL NIACIN PETROLATUM POLYSORBATE 20 POLYSORBATE 80 SORBITAN OLIVATE STYRENE VITIS VINIFERA SEED XANTHAN GUM ZINC OXIDE ZINC CATION TITANIUM DIOXIDE TITANIUM DIOXIDE
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 Scout
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
OTHER INFORMATION Protect this product from excessive heat and direct sunlight.
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 attention or contact poison control center immediately.
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? Contact us directly at 1-888-601-0441 Distr. by/par: Sunshine & Glitter MJ Products Association LLC 9750 NW 17th Street, Miami, FL 33172 www.sunshineglitter.com All Rights Reserved.
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 physician if irritation or rash develops.
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.
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 consult physician if irritation or rash develops. Keep out of reach of children. If product is swallowed, get medical attention or contact poison control center immediately.
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