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Sunscreen facestick spf30 - Prescription Drug Labeling

Product NDC Code 81055-000
Drug Name

Sunscreen facestick spf30

Type Brand
Active Ingredients
Zinc oxide 22 mg/100mg
Route TOPICAL
Dosage Form LOTION
Application Number part352
Labeler Name Llama Cosmetics LLC
Packages
Package NDC Code Description
81055-000-00 41 mg in 1 not applicable (81055-000-00)

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient(s) Zinc Oxide 22%wt

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 Directions -Apply generously and evenly 15 minutes before sun exposure -Children under 6 months of age: Ask a doctor -For sunscreen use apply to all skin exposed to the sun 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 -reapply after 80 minutes swimming or sweating -immediately after towel drying -at least every 2 hours

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Chlorella, Raw Cacao, Iron Oxide, Beeswax, Coconut Oil, Shea Butter, Vitamin E, Carrot Powder

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.
Sunscreen Facestick SPF30 FaceStick Sunscreen PEG-8 BEESWAX ZINC OXIDE ZINC OXIDE

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.
Albedo SPF 30 FaceStick Sunscreen SPF 30, Water Resistant 80min, Sunscreen Facestick Packaging SPF30 Facestick Image

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.
This product is manufactured with the ingredients as listed.

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 -in children less than 6 months of age -on open skin wounds

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.

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 irritation or rash occurs. These may be signs of a serious condition.

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.
Use as directed

Storage and handling

Information about safe storage and handling of the drug product.
Other information -Store at room temperature, avoid large variations in temperature. -Keep in dry conditions and avoid contact with moisture.

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 -When using this product keep out of eyes. Rinse with water to remove.

Disclaimer: Do not rely on openFDA 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