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| Product NDC Code | 0316-2064 | ||||
|---|---|---|---|---|---|
| Drug Name | Blue lizard sheer spf 50 sunscreen |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| 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 Ingredients Titanium Dioxide 9% Zinc Oxide 6%
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 prior to use Apply liberally to dry skin 15 minutes before sun exposure For topical use only Keep out of reach of children Children under 6 months: 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 to dry skin : after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours Keep out of reach of children
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aloe Barbadensis Leaf Juice, Alumina, Aluminum Stearate, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Carica Papaya (Papaya) Fruit Extract, Citric Acid, Citrus Aurantium Dulcis (Orange) Peel Extract, Crithmum Maritimum Extract, Cucumis Sativus (Cucumber) Fruit Extract, Diisopropyl Sebacate, Dimethoxydiphenylsilane/Triethoxycaprylylsilane Crosspolymer, Ethylhexylglycerin, Fucus Vesiculosus (Bladderwrack) Extract, Gamma-Nonalactone, Ginkgo Biloba (Ginkgo) Leaf Extract, Glycerin, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Hydrogenated Vegetable Oil, Isostearyl Alcohol, Isostearyl Isostearate, Phenoxyethanol, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Potassium Sorbate, Purified Water, Ricinus Communis (Castor) Seed Oil, Rosa Canina (Rosehip) Fruit Oil, Sclerocarya Birrea (Marula) Seed Oil, Sea Water, Sodium Benzoate, Sodium Chloride, Sorbitan Isostearate, Squalane, Tocopheryl Acetate (Vitamin E), Triethyl Citrate, and Xanthan Gum
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 and photodamage caused by UVA/UVB exposure Higher SPF gives more sunburn protection 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.Blue Lizard Sheer SPF 50 Sunscreen Titanium Dioxide, Zinc Oxide GLYCERIN HAMAMELIS VIRGINIANA LEAF GINKGO ALOE VERA LEAF ALUMINUM OXIDE ALUMINUM STEARATE SHEA BUTTER ALKYL (C12-15) BENZOATE MEDIUM-CHAIN TRIGLYCERIDES PAPAYA CITRIC ACID MONOHYDRATE ORANGE PEEL CRITHMUM MARITIMUM WHOLE CUCUMBER DIISOPROPYL SEBACATE DIMETHOXYDIPHENYLSILANE TRIETHOXYCAPRYLYLSILANE ETHYLHEXYLGLYCERIN FUCUS VESICULOSUS .GAMMA.-NONALACTONE ZINC OXIDE ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE HYDROGENATED PALM OIL HYDROGENATED RAPESEED OIL ISOSTEARYL ISOSTEARATE POTASSIUM SORBATE WATER CASTOR OIL SCLEROCARYA BIRREA SEED OIL SODIUM CHLORIDE SORBITAN ISOSTEARATE TRIETHYL CITRATE XANTHAN GUM SQUALANE POLYGLYCERYL-3 PENTARICINOLEATE .ALPHA.-TOCOPHEROL ACETATE ISOSTEARYL ALCOHOL PHENOXYETHANOL POLYHYDROXYSTEARIC ACID (2300 MW) ROSA CANINA FRUIT OIL SODIUM BENZOATE
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 Sheer Lotion - 3oz Tube Label BLUE LIZARD AUSTRALIAN SUNSCREEN 50+ Sheer Lotion mineral sunscreen UVA/UVB PROTECTION BROAD SPECTRUM SPF 50+ WATER RESISTANT (80 MINUTES) P11899.00 sheer-body-tube
Blue Lizard Sheer Lotion - 3oz Carton BLUE LIZARD AUSTRALIAN SUNSCREEN 50+ Sheer Lotion body mineral sunscreen UVA/UVB PROTECTION BROAD SPECTRUM SPF 50+ WATER RESISTANT (80 MINUTES) P11902.01 p1190201
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
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
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? Visit www.bluelizardsunscreen.com or call 800.877.8869 Crown Laboratories, Inc., Johnson City, TN 37604
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 When using this product Keep out of eyes. Rinse with water to remove Stop use and ask a doctor if Rash or irritation occurs Do not use On damaged or broken skin If allergic to any ingredient If swallowed, get medical help or contact a Poison Control Center
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