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| Product NDC Code | 63730-001 | ||||||||||
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| Drug Name | Diamond luminous uv defense light tinted fluid sunscreen broad spectrum spf 40 |
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| Type | Brand | ||||||||||
| Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||||||
| Dosage Form | LOTION | ||||||||||
| Application Number | M020 | ||||||||||
| Labeler Name | NATURA BISSE INTERNATIONAL SA | ||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Titanium dioxide 7.8% Zinc oxide 25% Purpose Sunscreen
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. 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 of 15 or higher and other sun protection measures including: Sun Protection Measures. limit time in the sun, especially from 10 a.m.–2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses. children under 6 months: Ask a doctor reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. Directions have changed from: apply liberally 15 minutes before sun exposure. reapply: 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 of 15 or higher and other sun protection measures including: Sun Protection Measures. To: apply liberally 15 minutes before sun exposure. 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 of 15 or higher and other sun protection measures including: after 40 minutes of swimming or sweating Immediately after tower drying at least every 2 hours. 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 limit time in the sun, especially from 10 a.m.–2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses. children under 6 months: Ask a doctor reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, C15-19 Alkane, Butyloctyl Salicylate, Niacinamide, Dimethicone, Coco-Caprylate Propanediol, PEG-30 Dipolyhydroxystearate, Caprylic/Capric Triglyceride, Polyglyceryl-6 Polyricinoleate, Polyglyceryl-6 Polyhydroxystearate, Diisopropyl Sebacate, Polyhydroxystearic Acid, Sodium Chloride, Silica, Tocopheryl Acetate, Arginine, Artemia Extract, Tocopherol, Lysine, Ascorbyl Palmitate,Triethoxycaprylylsilane, Stearalkonium Hectorite, Polyglycerin-6, Disodium EDTA, Propylene Carbonate, Cetyl Alcohol, Ethylhexylglycerin, Sodium Lauroyl Glutamate, Magnesium Chloride, Phenoxyethanol, Potassium Sorbate, Fragrance, Iron Oxides.
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 ) decreases the risk of skin cancer and early skin aging caused by the sun. Directions
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.Diamond Luminous UV Defense Light Tinted Fluid Sunscreen Broad Spectrum SPF 40 TITANIUM DIOXIDE, ZINC OXIDE WATER C15-19 ALKANE BUTYLOCTYL SALICYLATE NIACINAMIDE DIMETHICONE COCO-CAPRYLATE PROPANEDIOL PEG-30 DIPOLYHYDROXYSTEARATE MEDIUM-CHAIN TRIGLYCERIDES DIISOPROPYL SEBACATE POLYGLYCERYL-6 POLYRICINOLEATE SODIUM CHLORIDE SILICON DIOXIDE .ALPHA.-TOCOPHEROL ACETATE ARGININE TOCOPHEROL LYSINE ASCORBYL PALMITATE TRIETHOXYCAPRYLYLSILANE STEARALKONIUM HECTORITE POLYGLYCERIN-6 EDETATE DISODIUM ANHYDROUS PROPYLENE CARBONATE CETYL ALCOHOL ETHYLHEXYLGLYCERIN SODIUM LAUROYL GLUTAMATE MAGNESIUM CHLORIDE PHENOXYETHANOL POTASSIUM SORBATE FERRIC OXIDE RED TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC CATION
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.Package Labeling:63730-001-01 63730-001-01 Label
Package Labeling:63730-001-02 63730-001-02 inner label 63730-001-02 label 63730-001-02 outer label
Package Labeling:63730-001-03 63730-001-03 outer label 63730-001-03 inner label 63730-001-03 label
Package Labeling:63730-001-04 63730-001-04 outer label 63730-001-04 inner label 63730-001-04 label
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.Directions have changed from: apply liberally 15 minutes before sun exposure. reapply: 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 of 15 or higher and other sun protection measures including: Sun Protection Measures. To: apply liberally 15 minutes before sun exposure. 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 of 15 or higher and other sun protection measures including: after 40 minutes of swimming or sweating Immediately after tower drying at least every 2 hours. 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 limit time in the sun, especially from 10 a.m.–2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses. children under 6 months: Ask a doctor reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating.
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
Other information Protect the product in this container from excessive heat and direct sun.
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 Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-762-8872 M-F 9:00 AM to 5:00 PM
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 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