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| Product NDC Code | 14222-0425 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Rodan and fields essentials lip shield broad spectrum spf 25 |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | STICK | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | Rodan & Fields | ||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Avobenzone 2.5% Homosalate 8% Octisalate 5% Octocrylene 2.2%
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 and evenly, covering lips completely. 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 SPF 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-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 Beeswax, Hydrogenated Avocado Oil, Butyrospermum Parkii (Shea Butter), Persea Gratissima (Avocado) Oil, Simmondsia Chinesis (Jojoba) Seed Oil, Acacia Decurrens / Jojoba / Sunflower Seed Wax / Polyglyceryl-3 Esters, Sunflower (Helianthus Annuus) Seed Oil Unsaponifiables, Dimethicone, Fragrance, Ethylhexyl Palmitate, Hydrogenated Polydecene, Dunaliella Salina Extract, Palmitoyl Tripeptide-1, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Retinyl Palmitate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tribehenin, Sorbitan Isosterate.
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.Rodan and Fields ESSENTIALS Lip Shield Broad Spectrum SPF 25 Avobenzone, Homosalate, Octisalate, Octocrylene YELLOW WAX HYDROGENATED AVOCADO OIL SHEA BUTTER AVOCADO OIL JOJOBA OIL DIMETHICONE ETHYLHEXYL PALMITATE HYDROGENATED POLYDECENE (550 MW) DUNALIELLA SALINA PALMITOYL TRIPEPTIDE-1 TETRAHEXYLDECYL ASCORBATE .ALPHA.-TOCOPHEROL ACETATE VITAMIN A PALMITATE TEA TREE OIL TRIBEHENIN SORBITAN ISOSTEARATE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE
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 - Essentials Lip Shield Outer Label RODAN+FIELDS ® ESSENTIALS Lip Shield BROAD SPECTRUM SPF 25 Contains 2 Tubes 4.25 g/.15 Oz. Ea. Principal Display Panel - Essentials Lip Shield Outer Label
Principal Display Panel - Essentials Lip Shield Primary Label RODAN+FIELDS ® ESSENTIALS Principal Display Panel - Essentials Lip Shield Primary Label
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.on damaged or broken skin. Do not use
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.If product is swallowed, get medical help or contact Poison Control Center right away. 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 this product from excessive heat and sun.
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.if rash occurs. Stop use and ask a doctor
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.keep out of eyes. Rinse with water to remove. When using this product
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 on damaged or broken skin. Do not use keep out of eyes. Rinse with water to remove. When using this product if rash occurs. Stop use and ask a doctor If product is swallowed, get medical help or contact Poison Control Center right away. 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