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| Product NDC Code | 84138-0001 | ||||
|---|---|---|---|---|---|
| Drug Name | Thrive daily defense sunscreen balm spf30 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | Thrive Natural Care, Inc | ||||
| Packages |
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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 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours 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 value of 15 SPF 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, Coco-Caprylate, Dicaprylyl Carbonate, Glycerin, Microcrystalline Cellulose, Lauryl Glucoside, Propanediol, Cetyl Alcohol, Polyglyceryl-2 Dipolyhydroxystearate, Polyglyceryl-4 Laurate/Sebacate, Polyglyceryl-6 Caprylate/Caprate, Undaria Pinnatifida (Wakame) Extract, Coffea Arabica (Coffee) Seed Oil, Polyhydroxystearic Acid, Cellulose Gum, Xanthan Gum, Phytic Acid, Fridericia Chica (Arrabidaea Chica) Extract, Lippia Alba Oil, Hamelia Patens Extract, Ethyl Macadamiate, Tasmannia Lanceolata Fruit/Leaf Extract, Helianthus Annuus (Sunflower) Seed Oil, Triethoxycaprylylsilane, Rosmarinus Officinalis (Rosemary) Leaf Extract, Caprylyl Glyceryl Ether, Caprylhydroxamic Acid, Fragrance.
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.Thrive Daily Defense Sunscreen Balm SPF30 Zinc Oxide COCO-CAPRYLATE UNDARIA PINNATIFIDA LAURYL GLUCOSIDE CAPRYLHYDROXAMIC ACID CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED LIPPIA ALBA TOP OIL HAMELIA PATENS LEAF POLYHYDROXYSTEARIC ACID (2300 MW) XANTHAN GUM ZINC OXIDE ZINC OXIDE DICAPRYLYL CARBONATE MICROCRYSTALLINE CELLULOSE PROPANEDIOL ETHYL MACADAMIATE TASMANNIA LANCEOLATA FRUIT TRIETHOXYCAPRYLYLSILANE GLYCERIN FYTIC ACID POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE POLYGLYCERYL-4 LAURATE ROSEMARY CAPRYLYL GLYCERYL ETHER SUNFLOWER OIL POLYGLYCERYL-6 CAPRYLATE FRIDERICIA CHICA LEAF CETYL ALCOHOL ARABICA COFFEE OIL WATER
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 Thrive Skincare Powered by Regenerative Plants TM 30 Daily Defense Sunscreen Balm protects from sun hydrates & restores broadspectrum SPF 30 non-nano zinc oxide mineral sunscreen 2 FL. OZ. (60 ML) Outer packaging - unit carton
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-800-767-1549, Monday - Friday from 9 am PT to 5 pm PT
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