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| Product NDC Code | 82800-010 | ||||
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| Drug Name | Prequel sun barrier mineral sunscreen broad spectrum spf 50 |
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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 | CREAM | ||||
| Application Number | part352 | ||||
| Labeler Name | The Center Brands, LLC | ||||
| 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 Zinc Oxide 18%
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 generously 15 minutes before sun exposure • reapply: •at least every 2 hours. • use a water resistant sunscreen if swimming or sweating • 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 • children under 6 months of age: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water (Aqua), Caprylic/Capric Triglyceride, Diisooctyl Succinate, Butyloctyl Salicylate, Propanediol, Glycerin, Cetearyl Olivate, Polyhydroxystearic Acid, Sorbitan Olivate, Polyhydroxystearic Acid, Sorbitan Olivate, Bisabolol, Pongamia Pinnata Seed Extract, Zingiber Officinale Root Extract, Tetrahydrodiferuloylmethane, Tetrahydrodemethoxydiferuloylmethane, Tetrahydrodemethoxydiferuloylmethane, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita Flower Extract, Centella Asiatica Extract, Phenoxyethanol, Polyglyceryl-4 Laurate/Succinate, Lauroyl Lysine, Triethoxycaprylylsilane, Arachidyl Alcohol, Silica, Xanthan Gum, Potassium Cetyl Phosphate, Behenyl Alcohol, Caprylyl Glycol, VP/Eicosene Copolymer, Arachidyl Glucoside, Tetrasodium Glutamate Diacetate, Ethylhexylglycerin, Tocopheryl Acetate, Cetyl Alcohol, Tin Oxide, Isononyl Isononanoate, Ethylene/Propylene/Styrene Copolymer, Soribitan Oleate, Titanium Dioxide (CI 77891), Mica (CI 77019), Iron Oxides (CI 77499, CI 77491)
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
Spl product data elements
Usually a list of ingredients in a drug product.Prequel Sun Barrier Mineral Sunscreen Broad Spectrum SPF 50 Mineral Sunscreen WATER CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES DIISOCETYL ADIPATE BUTYLOCTYL SALICYLATE PROPANEDIOL GLYCERIN CETEARYL OLIVATE POLYHYDROXYSTEARIC ACID (2300 MW) SORBITAN OLIVATE .BETA.-BISABOLOL PONGAMIA PINNATA SEED ZINGIBER OFFICINALE WHOLE TETRAHYDRODIFERULOYLMETHANE TETRAHYDRODEMETHOXYDIFERULOYLMETHANE TETRAHYDROBISDEMETHOXYDIFERULOYLMETHANE CALENDULA OFFICINALIS FLOWER CAMELLIA SINENSIS SEED MATRICARIA CHAMOMILLA FLOWERING TOP CENTELLA ASIATICA PHENOXYETHANOL POLYGLYCERYL-4 LAURATE/SUCCINATE LAUROYL LYSINE TRIETHOXYCAPRYLYLSILANE ARACHIDYL ALCOHOL SILICON XANTHAN GUM POTASSIUM CETYL PHOSPHATE CAPRYLYL GLYCOL VINYLPYRROLIDONE/EICOSENE COPOLYMER ARACHIDYL GLUCOSIDE TETRASODIUM GLUTAMATE DIACETATE ETHYLHEXYLGLYCERIN CETYL ALCOHOL STANNIC OXIDE ISONONYL ISONONANOATE SORBITAN MONOOLEATE TITANIUM DIOXIDE MICA BROWN IRON OXIDE 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.Principal Display Panel 82800-010-01
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.Other Information • protect the product in this container from excessive heat and direct sun
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Visit prequelskin.com
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