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Well people lip butter spf 15 sunscreen wine - Medication Information

Product NDC Code 76354-491
Drug Name

Well people lip butter spf 15 sunscreen wine

Type Brand
Pharm Class Copper Absorption Inhibitor [EPC],
Decreased Copper Ion Absorption [PE]
Active Ingredients
Zinc oxide 100 mg/g
Route TOPICAL
Dosage Form CREAM
Application Number M020
Labeler Name e.l.f. Cosmetics, Inc
Packages
Package NDC Code Description
76354-491-01 1 bottle in 1 box (76354-491-01) / 2.2 g in 1 bottle
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Zinc Oxide 10% 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. Reapply at least every 2 hours. Use water resistant sunscreen if swimming or sweating. 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 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. Sun Protection Measures:

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Ricinus Communis (Castor) Seed Oil/Ricinus Communis Seed Oil*, Octyldodecanol, Heliathus Annuus (Sunflower) Seed Oil/Helianthus Annuus Seed Oil*, Jojoba Esters, Simmondsia Chinensis (Jojoba) Seed Oil/Simmondsia Chinensis Seed Oil* Copernicia Cerifera (Camauba) Wax/Copernicia Cerifera Cera*, Oleic/Linoleic/Linolenic Polyglycerides, Euphorbia Cerifera (Candelilla) Wax/Euphorbia Cerifera Cera, Helianthus Annuus (Sunflower) Seed Wax/Helianthus Annuus Seed Wax, Rubus Idaeus (Raspberry) Seed Oil/Rubus Idaeus Seed Oil, Dibutyl Lauroyl Glutamide, Mica, Caprylic/Capric Triglyceride, Tocopherol, Prunus Amygdalus Dulcis (Sweet Almond) Oil/Prunus Amygdalus Dulcis Oil, Ethylhexylglycerin, Acacia Decurrens Flower Wax, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Lecithin, Isostearic Acid, Polyglycerin-3, Daucus Carota Sativa (Carrot) Seed Oil/Daucas Carota Sativa Seed Oil, Vanilla Planifolia Fruit Oil, Mentha Viridis (Spearmint) Leaf Oil/Mentha Viridis Leaf Oil, Camellia Sinensis (Green Tea) Leaf Extract/Camellia Sinensis Leaf Extract ,Limonene MAY CONTAIN: Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499), Red 7 Lake (CI 15850), Red 33 Lake (CI 17200) *Orgainc Ingredients

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.
Use 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.
Well People Lip Butter SPF 15 Sunscreen WINE ZINC OXIDE OCTYLDODECANOL HELIANTHUS ANNUUS FLOWERING TOP SUNFLOWER OIL JOJOBA OIL CARNAUBA WAX CANDELILLA WAX HELIANTHUS ANNUUS SEED WAX RASPBERRY SEED OIL DIBUTYL LAUROYL GLUTAMIDE MICA MEDIUM-CHAIN TRIGLYCERIDES TOCOPHEROL ALMOND OIL ETHYLHEXYLGLYCERIN ACACIA DECURRENS FLOWER WAX POLYGLYCERYL-3 PENTARICINOLEATE CARROT SEED OIL CASTOR OIL VANILLA PLANIFOLIA OIL SPEARMINT OIL GREEN TEA LEAF LIMONENE, (+)- 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: label3

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 a 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 or comments? 1-888-315-9814

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.
Warning 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