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Product NDC Code | 83046-369 | ||||
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Drug Name | Oars and alps spf 50 100% mineral antioxidant sunscreen |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SPRAY | ||||
Application Number | M020 | ||||
Labeler Name | Oars and Alps LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Titanium Dioxide - 3.4% Zinc Oxide - 15.7%
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 generously and evenly 15 minutes before sun exposure Hold container 4-6 inches from the skin to apply Do not spray directly onto the face. Spray onto hands and rub onto face. Do not inhale. Do not apply in windy conditions. Use in well ventilated area. Reapply: After 80 minutes of swimming or sweating, immedately after towl 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 value 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-sleeved shirts, pants, hats, and sunglasses. Children under six months: Ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Aloe Barbadensis Leaf Juice, Alumina, Bentonite, Bisabolol, Butyloctyl Salicylate, C18-21 Alkane, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Citric Acid, Cladonia Stellaris Extract, Coco-Glucoside, Dicaprylyl Carbonate, Glycerin, Isocetyl Stearoyl Stearate, Isononyl Isononanoate, Methyl Dihydroabietate, Microcrystalline Cellulose, Polyester-8, Polyhydroxystearic Acid, Propanediol, Sclerocarya Birrea Seed Oil, Silica, Sodium Gluconate, Sodium Stearoyl Glutamate, Tocopherol, Water
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.Oars and Alps SPF 50 100% Mineral Antioxidant Sunscreen Titanium Dioxide, Zinc Oxide ZINC OXIDE ZINC OXIDE GLYCERIN SCLEROCARYA BIRREA SEED OIL BENTONITE CAPRYLYL GLYCOL ISONONYL ISONONANOATE POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) DICAPRYLYL CARBONATE METHYL DIHYDROABIETATE POLYHYDROXYSTEARIC ACID (2300 MW) SILICON DIOXIDE SODIUM STEAROYL GLUTAMATE WATER C18-C21 ALKANE CAPRYLHYDROXAMIC ACID CETOSTEARYL ALCOHOL CLADONIA RANGIFERINA WHOLE TOCOPHEROL ALOE VERA LEAF ALUMINUM OXIDE BUTYLOCTYL SALICYLATE COCO GLUCOSIDE PROPANEDIOL CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED LEVOMENOL CITRIC ACID MONOHYDRATE ISOCETYL STEAROYL STEARATE SODIUM GLUCONATE TITANIUM DIOXIDE TITANIUM DIOXIDE MICROCRYSTALLINE CELLULOSE
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 the product in this container from excessive heat and direct sun Avoid spraying on facbrics - may cause discoloration
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Contact [email protected]
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 a doctor if 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