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Product NDC Code | 79753-048 | ||||
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Drug Name | Bare republic spf 50 mineral sunscreen vanilla coco |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SPRAY | ||||
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 - 4.3% Zinc Oxide - 15.0%
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. Hold container 4 to 6 inches from skin to apply. Rub in. Do not spray directly on face. Spray onto hands and apply to face. • When properly used, mineral sunscreens will leave a whitish tint when first applied. • Reapply: • after 80 minutes of swimming or sweating • immediately afrer 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, Helianthus Anuus (Sunflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Butyloctyl Salicylate, lsocetyl Stearoyl Stearate, Methyl Dihydrobietate, Polysorbate 20, Cetearyl Alcohol, Bentonite, Propanediol, Aloe Barbadensis Leaf Juice, Vitis Vinifera (Grape) Seed Oil, Rubus ldaeus (Raspberry) Seed Oil, Daucus Carota Saliva (Carrot) Seed Oil, Bisabolol, Coco-Glucoside, Microstalline Cellulose, Cellulose Gum, Sodium Gluconate, Sodium Stearoyl Glutamate, Caprylhydroxamic Acid, Polyester-8, Alumina, Silica, Tocopherol, Citric Acid, Caprylic/Capric Triglyceride, Alcohol, Vanillin, Gamma-Nonalactone, Allyl Heptoate, Gamma Octalactone, Heliotropine, Raspberry Ketone, Triethyl Citrate
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 SPF 50 Mineral Sunscreen Vanilla Coco Titanium Dioxide, Zinc Oxide PIPERONAL OLIVE OIL POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) WATER TRIETHYL CITRATE TOCOPHEROL PROPANEDIOL SODIUM GLUCONATE SODIUM STEAROYL GLUTAMATE CAPRYLHYDROXAMIC ACID POLYSORBATE 20 ALOE VERA LEAF CARROT SEED OIL ZINC OXIDE ZINC OXIDE SUNFLOWER OIL CETOSTEARYL ALCOHOL ALCOHOL VANILLIN .GAMMA.-OCTALACTONE TITANIUM DIOXIDE TITANIUM DIOXIDE GRAPE SEED OIL BUTYLOCTYL SALICYLATE ISOCETYL STEAROYL STEARATE METHYL DIHYDROABIETATE SILICON DIOXIDE MICROCRYSTALLINE CELLULOSE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM ALUMINUM OXIDE CITRIC ACID MONOHYDRATE COCO GLUCOSIDE 4-(P-HYDROXYPHENYL)-2-BUTANONE MEDIUM-CHAIN TRIGLYCERIDES .GAMMA.-NONALACTONE ALLYL HEPTANOATE BENTONITE RASPBERRY SEED OIL LEVOMENOL
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 product is 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.May stain fabrics 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 Flammable : Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120° F. Do not use in the presence of a flame or spark, or while smoking. Do not use on damaged or broken skin When using this product keep away from face to avoid breathing in • Keep out of eyes. Rinse with water to remove. Apply outdoors. Avoid overspray as could cause surface to become slippery. Do not apply in windy conditions. Use in a well ventilated area. 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