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Product NDC Code | 79753-063 | ||||
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Drug Name | Bare republic mineral shimmer spf 30 diamond dust |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LOTION | ||||
Application Number | M020 | ||||
Labeler Name | COOLA, LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Titanium Dioxide - 6.4% Zinc Oxide - 4.2%
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. Apply liberally 15 minutes before sun exposure Reapply: • After 40 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours 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 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-sleeve shirts, pants, hats, and sunglasses Children under 6 months: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Water, Cocos Nucifera (Coconut) Oil, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetyl Alcohol, Synthetic Fluorphlogopite, Sodium Stearoyl Glutamate, Fragrance, Helianthus Annuus (Sunflower) Seed Oil, Polyhydroxystearic Acid, Tocopherol, Glycerin, Tocopherol, Moringa Oleifera Seed Oil, Aloe Barbadensis Leaf Juice, Citric Acid, Coco-Glucoside, Glyceryl Stearate, Xanthan Gum, Aluminum Hydroxide, Caprylyl Glycol, Stearic Acid, Silica, Calcium Sodium Borosilicate, Sodium Gluconate, Caprylhydroxamic Acid, Iron Oxides, Mica, Amethyst Powder
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.Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Bare Republic Mineral Shimmer SPF 30 Diamond Dust Titanium Dioxide, Zinc Oxide POLYHYDROXYSTEARIC ACID (2300 MW) TOCOPHEROL XANTHAN GUM STEARIC ACID SILICON DIOXIDE CALCIUM ALUMINUM BOROSILICATE MICA WATER FERRIC OXIDE RED MORINGA OLEIFERA SEED OIL ALUMINUM HYDROXIDE CAPRYLHYDROXAMIC ACID CETOSTEARYL ALCOHOL MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE COCONUT OIL TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE ALOE VERA LEAF SODIUM GLUCONATE CAPRYLYL GLYCOL GLYCERIN CETYL ALCOHOL CITRIC ACID MONOHYDRATE GLYCERYL MONOSTEARATE LEVOMENOL BUTYLOCTYL SALICYLATE DISODIUM STEAROYL GLUTAMATE COCO GLUCOSIDE SUNFLOWER OIL STANNIC OXIDE
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.1
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.Protect this product from excessive heat and direct sun
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Call 760-940-2125
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.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 skin 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