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Cyberderm simply zinc lite - Medication Information

Product NDC Code 71644-008
Drug Name

Cyberderm simply zinc lite

Type Brand
Pharm Class Copper Absorption Inhibitor [EPC],
Decreased Copper Ion Absorption [PE]
Active Ingredients
Zinc oxide 25 g/100ml
Route TOPICAL
Dosage Form LOTION
Application Number M020
Labeler Name Cyberderm Laboratories Inc.
Packages
Package NDC Code Description
71644-008-01 1 bottle in 1 carton (71644-008-01) / 100 ml in 1 bottle
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Zinc oxide* 25%

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 Adults and children over 6 months of age Apply liberally to face and body 15 minutes before sun exposure Reapply at least every 2 hours Use a water-resistant sunscreen if swimming or sweating 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

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Non-medicinal ingredients caprylic/capric triglyceride*, coco-caprylate/caprate*, polyglyceryl-3 polyricinoleate*, isostearic acid*, polylactic acid*, coconut alkanes*, sodium-phospho-magnesium silicate, carthamus tinctorius oleosomes*, water/eau, picea abies extract, propanediol*, titanium dioxide, stearic acid, alumina, cerium dioxide, silica, aluminum hydroxide, polyhydroxystearic acid.

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.
Cyberderm Simply Zinc Lite Zinc oxide CARTHAMUS TINCTORIUS SEED OLEOSOMES PICEA ABIES FLOWER BUD STEARIC ACID ALUMINUM OXIDE POLYGLYCERYL-3 RICINOLEATE TITANIUM DIOXIDE CERIC OXIDE SILICON DIOXIDE ALUMINUM HYDROXIDE POLYHYDROXYSTEARIC ACID (2300 MW) COCONUT ALKANES ZINC OXIDE ZINC CATION ISOSTEARIC ACID WATER COCO-CAPRYLATE/CAPRATE POLYLACTIDE MEDIUM-CHAIN TRIGLYCERIDES PROPANEDIOL

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.
cyberderm made with love by the sunscreen company™ Simply Zinc Lite Transparent sunscreen lotion made with 25% zinc oxide with Certified Organic Bio UVA Ultra and Sheer Illuminating Tint UVA/UVB Broad Spectrum SPF 50 helps prevent sunburn 100 mL (3.4 fl oz) Simply Zinc Lite

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 Distributed by: Cyberderm Laboratories Incorporated 650-1600 Carling Avenue Ottawa, ON K1Z 1G3 Canada Made in Canada www.thesunscreencompany.com

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 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, call a Poison Control Center or get medical help or 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? 718-481-2628 Monday - Friday 9 am - 5 pm

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 avoid contact eyes. If contact occurs, rinse thoroughly with water.

Storage and handling

Information about safe storage and handling of the drug product.
Other information Protect this product from excessive heat and direct sun

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

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