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| Product NDC Code | 58443-0661 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Naked sundays spf 50 broad spectrum |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | SPRAY | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | Prime Enterprises | ||||||||
| 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 Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 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 avoid eye area shake well before use use as top up sunscreen only hold 8-10" away from your body and spray liberally & evenly until skin feels moist 15 minutes before sun exposure. Do not spray directly on to face. Make sure no spots are missed by spraying onto hands and applying to face Do not apply in windy conditions Use in well-ventlated area Avoid inhalation Use a water resistant sunscreen if swimming or sweating Reapply immediately after towel drying Reapply 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 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 am to 2 pm. Wear long-sleeved shirts, pants, hats, and sunglasses
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Ethanol, Citrullus Lanatus Seed Oil, Hyaluronic Acid, Kakadu Plum, Tocopheryl Acetate, Fragrance
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.Naked Sundays SPF 50 Broad Spectrum Avobenzone, Homosalate, Octisalate, Octocrylene OCTOCRYLENE OCTOCRYLENE OCTISALATE OCTISALATE WATERMELON SEED OIL KAKADU PLUM AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE ALCOHOL HYALURONIC ACID WATER .ALPHA.-TOCOPHEROL ACETATE GLYCERIN Light Yellow to Yellow
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.Naked Sundays Hydrating Glow Mist Broad Spectrum SPF 50+ Principal Display Label
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.Other Information Protect the product in this container from excessive heat and direct sun
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 help or contact a Poison Control Center right away
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 Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging Flammable: Keep away from flames and sparks. Wait 5/10 minutes after application before approaching a source of heat or flame, or before smoking. 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 product is 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