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| Product NDC Code | 82757-102 | ||||
|---|---|---|---|---|---|
| Drug Name | The mineral melt spf30 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | M020 | ||||
| Labeler Name | Dune Suncare Inc. | ||||
| 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, 2.3% Zinc oxide, 4.8%
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 and evenly 15 minutes before sun exposure Reapply at least every 2 hours use a water-resistant sunscreen if swimming or sweating: immediately after towel drying 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 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.-2p.m. Wear long-sleeved shirts, pants, hats, and sunglasses
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water/Aqua/Eau, Caprylic/Capric Triglyceride, Glycerin, Dimethicone, Maltodextrin, Polyester-8, Benzyl Alcohol, Sodium Acrylate/Sodium Acryloylddimethyl Taurate Copolymer, Hydrogenated Lecithin, Glyceryl Caprylate, C15-19 Alkane, Silica, Polyhydroxystearic Acid, Alumina, Stearic Acid, Xanthan Gum, Triethoxycaprylylsilane, Polyglyceryl-6 Laurate, Caprylhydroxamic Acid, Sodium Hydroxide, Carnosine, Polyglycerin-6, Canola Oil, Sorbitan Oleate, Caesalpinia Spinosa Fruit Pod Extract, Sorbitan Isostearate, Cistus Monspeliensis Extract, Helianthus Annuus (Sunflower) Sprout Extract, Daucus Carota Sativa (Carrot) Root Extract, Daucus Carota Sativa (Carrot) Seed Oil, Beta-Carotene, Helianthus Annuus (Sunflower) Seed Oil, Tocopheryl Acetate
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 Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.The Mineral Melt SPF30 Zinc Oxide, Titanium Dioxide Zinc Oxide Zinc Oxide Titanium Dioxide Titanium Dioxide Water Medium-Chain Triglycerides Glycerin Dimethicone Maltodextrin Polyester-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) Benzyl Alcohol Sodium Acrylate/Sodium Acryloyldimethyltaurate Copolymer (4000000 MW) Hydrogenated Soybean Lecithin Glyceryl Monocaprylate C15-19 Alkane Silicon Dioxide Polyhydroxystearic Acid (2300 MW) Aluminum Oxide Stearic Acid Xanthan Gum Triethoxycaprylylsilane Polyglyceryl-6 Laurate Caprylhydroxamic Acid Sodium Hydroxide Caesalpinia Spinosa Fruit Pod Carnosine Polyglycerin-6 Canola Oil Sorbitan Monooleate Sorbitan Isostearate Helianthus Annuus Sprout Cistus Monspeliensis Whole Carrot Carrot Seed Oil Beta Carotene Sunflower Oil .Alpha.-Tocopherol Acetate The Mineral Melt SPF30 Zinc Oxide, Titanium Dioxide Zinc Oxide Zinc Oxide Titanium Dioxide Titanium Dioxide Water Medium-Chain Triglycerides Glycerin Dimethicone Maltodextrin Polyester-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) Benzyl Alcohol Sodium Acrylate/Sodium Acryloyldimethyltaurate Copolymer (4000000 MW) Hydrogenated Soybean Lecithin Glyceryl Monocaprylate C15-19 Alkane Silicon Dioxide Polyhydroxystearic Acid (2300 MW) Aluminum Oxide Stearic Acid Xanthan Gum Triethoxycaprylylsilane Polyglyceryl-6 Laurate Caprylhydroxamic Acid Sodium Hydroxide Caesalpinia Spinosa Fruit Pod Carnosine Polyglycerin-6 Canola Oil Sorbitan Monooleate Sorbitan Isostearate Helianthus Annuus Sprout Cistus Monspeliensis Whole Carrot Carrot Seed Oil Beta Carotene Sunflower Oil .Alpha.-Tocopherol Acetate
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 – 50 mL Bottle Label DUNE THE MINERAL MELT INVISIBLE MINERAL SUNCARE FOR FACE BROAD SPECTRUM SPF 30 Sheerest Mineral Hydration Enriched with Youth Peptides Non-Comedogenic Fragrance Free 50 mL 1.7 FL OZ Principal Display Panel – 50 mL Bottle Label
Principal Display Panel – 2 mL Packet Label DUNE SUNCARE THE MINERAL MELT INVISIBLE MINERAL SUNCARE FOR FACE BROAD SPECTRUM SPF 30 Doctor-Developed Hydrating, Brightening & Firming Non-Comedogenic Fragrance Free 2 mL 0.067 FL OZ Principal Display Panel – 2 mL Packet Label
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 swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information protect the product in this container from excessive heat and direct sun
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 a 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.
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 a doctor if rash occurs 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