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Blue lizard kids spf 50 - Medication Information

Product NDC Code 0316-2012
Drug Name

Blue lizard kids spf 50

Type Brand
Active Ingredients
Zinc oxide 20 mg/g
Route TOPICAL
Dosage Form STICK
Application Number M020
Labeler Name Crown Laboratories
Packages
Package NDC Code Description
0316-2012-05 1 cylinder in 1 blister pack (0316-2012-05) / 14 g in 1 cylinder
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Zinc Oxide 20%

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 liberally 15 minutes before sun exposure • 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 Aloe Barbadensis Leaf Extract, Behenyl Behenate, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil, Euphorbia Cerifera (Candelilla) Wax, Helianthus Annuus (Sunflower) Seed Oil, Helianthus Annuus (Sunflower) Seed Wax, Polyhydroxystearic Acid, Ricinus Communis (Castor) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Squalane, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol

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 Kids SPF 50 zinc oxide BEHENYL BEHENATE COCONUT OIL POLYHYDROXYSTEARIC ACID STEARATE CASTOR OIL .ALPHA.-TOCOPHEROL, D- JOJOBA OIL ALOE VERA LEAF MEDIUM-CHAIN TRIGLYCERIDES SUNFLOWER OIL COCOA BUTTER HELIANTHUS ANNUUS SEED WAX CANDELILLA WAX SQUALANE SHEA BUTTER ZINC OXIDE ZINC OXIDE

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 Kids SPF 50+ Stick Label BLUE LIZARD AUSTRALIAN SUNSCREEN 50+ UVA/UVB PROTECTION BROAD SPECTRUM SPF 50+ KIDS mineral sunscreen stick Water Resistant (80 Minutes) Net wt. 0.5oz (14g) P11679.02 BL Kids Stick P11679_02 Blue Lizard Kids SPF 50+ Stick Backer Card P11681.02 BL Kids Stick Backer Card P11681_02

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.
Uses [Indications and Usage section] sequence 3 - revised Uses section to comply with current sunscreen monograph Directions [Dosage and Administration section] sequence 5 - revised Directions section to comply with current sunscreen monograph

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 Distributed by Crown Laboratories, Inc., Johnson City, TN 37604

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 kepp 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 Do not use on damaged or broken skin When using this product kepp 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