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Blue lizard sport spf 50 - Medication Information

Product NDC Code 0316-2080
Drug Name

Blue lizard sport spf 50

Type Brand
Active Ingredients
Zinc oxide 24 mg/g
Route TOPICAL
Dosage Form SPRAY
Application Number M020
Labeler Name Crown Laboratories
Packages
Package NDC Code Description
0316-2080-05 142 g in 1 bottle, spray (0316-2080-05)
0316-2080-45 127.6 g in 1 bottle, spray (0316-2080-45)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Zinc Oxide 24%

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 before and frequently during use • apply liberally 15 minutes before sun exposure • 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 • 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 a.m.- 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylyl Glycol, Cetyl Diglyceryl Tris(Trimethylsiloxy)silylethyl Dimethicone, Copper Gluconate, Dimethicone, Ethylhexylglycerin, Glycerin, Hydrogen Dimethicone, Hydrogenated Polydecene, Isopropyl Myristate, Magnesium Aspartate, Pentylene Glycol, Phenoxyethanol, Polyhydroxystearic Acid, Propanediol, Silica, Sodium Chloride, Sodium Phytate, Sorbitan Olivate, Synthetic Beeswax, Tetrafluoropropene, Water, Zinc Gluconate

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

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.
Blue Lizard Sport SPF 50 zinc oxide ETHYLHEXYLGLYCERIN DIMETHICONE HYDROGENATED POLY(C6-14 OLEFIN; 4 CST) PHYTATE SODIUM CETYL DIGLYCERYL TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE (3500 MM2/S) ALKYL (C12-15) BENZOATE ISOPROPYL MYRISTATE MAGNESIUM ASPARTATE SODIUM CHLORIDE WATER COPPER GLUCONATE HYDROGEN DIMETHICONE (20 CST) SYNTHETIC BEESWAX SORBITAN OLIVATE ZINC GLUCONATE PHENOXYETHANOL CAPRYLYL GLYCOL BUTYLOCTYL SALICYLATE POLYHYDROXYSTEARIC ACID (2300 MW) 1,3,3,3-TETRAFLUOROPROPENE, (1E)- ZINC OXIDE ZINC OXIDE GLYCERIN PENTYLENE GLYCOL SILICON DIOXIDE PROPANEDIOL

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.
Blue Lizard Sport SPF 50+ Spray 5 oz Label BLUE LIZARD AUSTRALIAN SUNSCREEN 50+ UVA/UVB PROTECTION BROAD SPECTRUM SPF 50+ Trusted by dermatologists for over 20 years Sport mineral sunscreen spray Water Resistant (80 Minutes) 100% Mineral Active Ingredient Made with Earth Friendly Propellant P11908.03 Sport Spray

Recent major changes

A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.
formatted Uses section formatted Directions section

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, 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.
Other information protect the product in this container from excessive heat and direct sun may stain some fabrics

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? Call 800.877.8869 or visit www.bluelizardsunscreen.com

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 Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 ˚F Flammable: keep away from fire or flame 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 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