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Sport sunscreen spf 50 - Medication Information

Product NDC Code 59450-943
Drug Name

Sport sunscreen spf 50

Type Brand
Active Ingredients
Avobenzone 30 mg/g
Homosalate 120 mg/g
Octisalate 50 mg/g
Route TOPICAL
Dosage Form SPRAY
Application Number M020
Labeler Name Kroger
Packages
Package NDC Code Description
59450-943-14 156 g in 1 can (59450-943-14)
59450-943-15 258 g in 1 can (59450-943-15)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Avobenzone 3% Homosalate 12% Octisalate 5%

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 ■ spray liberally and spread evenly by hand 15 minutes before sun exposure ■ apply to all skin exposed to the sun ■ hold container 4 to 6 inches from the skin to apply ■ do not spray directly into face. Spray on hands then apply to face. ■ do not apply in windy conditions ■ use in a well-ventilated area and avoid inhalation ■ reapply: ■ after 80 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 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 6 months of age: Ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients alcohol denat., diethylhexyl 2,6-naphthalate, diisopropyl adipate, acrylates/octylacrylamide copolymer, butyloctyl salicylate, neopentyl glycol diheptanoate, fragrance, amyl cinnamal, hydroxycitronellal, linalool, 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

Spl product data elements

Usually a list of ingredients in a drug product.
Sport Sunscreen SPF 50 Avobenzone, Homosalate, Octisalate ALCOHOL DIETHYLHEXYL 2,6-NAPHTHALATE DIISOPROPYL ADIPATE ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (40000 MW) BUTYLOCTYL SALICYLATE NEOPENTYL GLYCOL DIHEPTANOATE .ALPHA.-AMYLCINNAMALDEHYDE HYDROXYCITRONELLAL LINALOOL, (+/-)- .ALPHA.-TOCOPHEROL ACETATE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE

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 compare to COPPERTONE ® SPORT SPF 50 SPRAY *see back panel Kroger ® SPORT SUNSCREEN SPRAY BROAD SPECTRUM SPF 50 UVA/UVB sunscreen continuous spray water resistant (80 minutes) sweat resistant hypoallergenic for active lifestyles SPF50 NET WT 5.5 OZ (156 g) image description

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.
Claims Kroger Sport Sunscreen Spray 50 provides quick and easy coverage with broad-spectrum protection. Its clear, specially formulated spray goes on at any angle. Water-resistant formual provides protection in and out of the water for up to 80 minutes. Flammable Flammable: keep away from fire or flame. After application, wait until product dries before approaching a source of heat or flame, or before smoking Disclaimer May stain or damage some fabrics or surfaces *This product is not manufactured or distributed by Beiersdorf AG, distributor of Coppertone ® Sunscreen Spray Sport Broad Spectrum SPF 50. Adverse Reaction DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202 QUALITY GUARANTEE 800-632-6900 www.kroger.com

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, seek immediate medical attention or call 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. contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.

Storage and handling

Information about safe storage and handling of the drug product.
Other information protect the product in this container from excessive heat and direct sun

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

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