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Green screen spf 31 nude sunscreen - Medication Information

Product NDC Code 73369-0004
Drug Name

Green screen spf 31 nude sunscreen

Type Brand
Active Ingredients
Zinc oxide 25 g/100g
Route TOPICAL
Dosage Form CREAM
Application Number M020
Labeler Name Kabana Skin Care LLC
Packages
Package NDC Code Description
73369-0004-1 115 g in 1 tube (73369-0004-1)
73369-0004-2 30 g in 1 tube (73369-0004-2)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Zinc Oxide** USP 25% 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.
apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply: after swimming or sweating immediately after towel drying 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 value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 AM – 2 PM. Wear long-sleeved shirts, pants, hats and sunglasses. Children under 6 months. Ask a doctor Directions apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply: after swimming or sweating immediately after towel drying 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 Eldorado Springs Artesian Water (aqua), extra virgin olive oil* (Oleo europaea fruit oil), jojoba oil* (Simmondsia chinensis oil), vegetable glycerin # (glycerin), shea butter (Butyrospermum parkii seed oil), vegetable emulsifying wax NF # (cetearyl alcohol and polysorbate 60), vegetable vitamin e # (tocopherol), iron oxide (iron oxides) *Certified Organic by USDA/NOP # Non-GMO

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.
Green Screen SPF 31 Nude Sunscreen Zinc Oxide ZINC OXIDE ZINC OXIDE JOJOBA OIL FERROSOFERRIC OXIDE ALPHA-TOCOPHEROL POLYSORBATE 60 WATER SHEA BUTTER FERRIC OXIDE RED CETOSTEARYL ALCOHOL OLIVE OIL FERRIC OXIDE YELLOW GLYCERIN

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.
Drug Facts Green Screen SPF 31 Nude Sunscreen Package Insert

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
children under 6 months: Ask a Doctor

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

Instructions for use

Information about safe handling and use of the drug product.
Directions apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply: after swimming or sweating immediately after towel drying 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

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 product is swallowed, get medical help or contact a Poison Control Center right away Keep out of reach of children, if product is swallowed, get medical help or contact a Poison Control Center right away Keep out of reach of children, if product is 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 this product 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 or comments? Call Kabana Skin Care toll free at 1-888-517-0414 or visit www.kabanaskincare.com

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 if used as directed with other sun protection measures 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 product is swallowed, get medical help or contact a Poison Control Center right away Keep out of reach of children, if product is swallowed, get medical help or contact a Poison Control Center right away Keep out of reach of children, if product is 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