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Product NDC Code | 52854-625 | ||||
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Drug Name | Land shark zinky spf 36 pink beach |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
Application Number | M020 | ||||
Labeler Name | Tropical Seas, Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Zinc Oxide 24.0%
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 nosecoat to cheeks, nose, and other areas. Apply a liberal coating of your favorite color, but do not rub into your skin. You want a thick noticable color coat on the area. For ultimate protection, apply on top of our Land Shark Sunscreen lotions or sprays 15 minutes prior to sun exposure! Reapply after 80 minutes of swimming or sweating or more often if you burn easily or have sensitive skin. 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 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses children under 6 months: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients ricinus communis (castor) seed oil, cetearyl alcohol, lauryl laurate, olea europaea (olive) oil, hydrogenated castor oil, beeswax, copernicia cerifera (carnauba) wax, flavor, hydrogenated soybean oil, euphorbia cerifera (candelilla) wax, glyceryl stearate, cocos nucifera (coconut) fruit extract, cyclopentasiloxane (and) peg-10 dimethicone (and) triethoxycaprylsilan, hydrogenated olive oil, stearyl esters, lauryl lactate, cetyl dimethicone, and synthetic fluorphlogopite (and) titanium dioxide (and) carmine (and) tin oxide.
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.Land Shark Zinky SPF 36 Pink Beach zinc oxide PIGMENT RED 5 STANNIC OXIDE HYDROGENATED OLIVE OIL CYCLOMETHICONE 5 PEG-10 DIMETHICONE (600 CST) CANDELILLA WAX CASTOR OIL CETOSTEARYL ALCOHOL LAURYL LAURATE OLIVE OIL HYDROGENATED CASTOR OIL YELLOW WAX CARNAUBA WAX HYDROGENATED SOYBEAN OIL GLYCERYL STEARATE SE COCONUT CETYL DIMETHICONE 150 HIPPOPHAE RHAMNOIDES SEED OIL ZINC OXIDE ZINC OXIDE HYDROGENATED OLIVE OIL STEARYL ESTERS TRIETHOXYCAPRYLYLSILANE LAURYL LACTATE TITANIUM DIOXIDE MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE
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 - Label 14g NDC 52854-615-01 Jar Label 14g NDC 52854-615-01 Blister Card Front 14g NDC 52854-615-01 Blister Card Back 14g NDC 52854-615-01 Jar Label 14g NDC 52854-615-01 Blister Card Front 14g NDC 52854-615-01 Blister Card Back
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.Drug Facts
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.
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
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 *Keep out of eyes Stop use and ask a doctor if rash occurs Keep out of reach of children.
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