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| Product NDC Code | 0316-2011 | ||||
|---|---|---|---|---|---|
| Drug Name | Blue lizard baby spf 50 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | STICK | ||||
| Application Number | M020 | ||||
| Labeler Name | Crown Laboratories | ||||
| 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 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 to dry skin 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 Baby SPF 50 zinc oxide SQUALANE SHEA BUTTER MEDIUM-CHAIN TRIGLYCERIDES ZINC OXIDE ZINC OXIDE COCOA BUTTER HELIANTHUS ANNUUS SEED WAX CANDELILLA WAX BEHENYL BEHENATE COCONUT OIL POLYHYDROXYSTEARIC ACID STEARATE CASTOR OIL .ALPHA.-TOCOPHEROL, D- JOJOBA OIL ALOE VERA LEAF SUNFLOWER OIL
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 Baby SPF 50+ Stick Label BLUE LIZARD AUSTRALIAN SUNSCREEN 50+ UVA/UVB PROTECTION BROAD SPECTRUM SPF 50+ Baby mineral sunscreen stick Water Resistant (80 Minutes) Net wt. 0.5oz (14g) P11671.02 BL Baby Stick P11671_02
Blue Lizard Baby SPF 50+ Backer Card P11673.02 BL Baby Stick Backer Card P11673_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] 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 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 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