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Derma e vitamin c weightless moisturizer spf 45 - Medication Information

Product NDC Code 54108-0359
Drug Name

Derma e vitamin c weightless moisturizer spf 45

Type Brand
Active Ingredients
Zinc oxide 200 mg/ml
Route TOPICAL
Dosage Form LOTION
Application Number M020
Labeler Name derma e
Packages
Package NDC Code Description
54108-0359-1 1 bottle in 1 box (54108-0359-1) / 60 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 20%

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 shake well apply liberally 15 minutes before sun exposure Children under 6 months of age: Ask a doctor 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 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 reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Apium Gravelones (Celery) Seed Extract, Aspalathus Linearis (Rooibos) Leaf Extract, Caprylic/Capric Triglyceride, Cocoglycerides, Diethylhexyl Succinate, Ethylhexylglycerin, Ethylhexyl Olivate, Glycerin, Isostearic Acid, Jojoba Esters, Lauryl Glucoside, Lecithin, Linum Usitatissimum (Linseed) Seed Extract, Natural Fragrance Oil, Niacinamide, Panthenol, Phenoxyethanol, Polyglyceryl-2 Dipolyhydroxystearate, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Purified Water, Sodium Ascorbyl Phosphate, Sodium Carboxymethyl Starch, Sodium Phytate, Sorbitan Trioleate, Tetrahexyldecyl Ascorbate, Titanium Dioxide, Tocopheryl Acetate Vitamin E), Xanthan Gum. *Certified Organic 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.
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.
Derma E Vitamin C Weightless Moisturizer SPF 45 Zinc oxide ZINC OXIDE ZINC OXIDE WATER DIETHYLHEXYL SUCCINATE MEDIUM-CHAIN TRIGLYCERIDES ETHYLHEXYL OLIVATE POLYHYDROXYSTEARIC ACID (2300 MW) COCO-GLYCERIDES GLYCERIN SODIUM STARCH GLYCOLATE TYPE A LAURYL GLUCOSIDE POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE PHENOXYETHANOL .ALPHA.-TOCOPHEROL ACETATE TETRAHEXYLDECYL ASCORBATE POLYGLYCERYL-3 PENTARICINOLEATE ISOSTEARIC ACID LECITHIN, SUNFLOWER TITANIUM DIOXIDE PHYTATE SODIUM NIACINAMIDE PANTHENOL ETHYLHEXYLGLYCERIN FRAGRANCE 13576 XANTHAN GUM ASPALATHUS LINEARIS LEAF SORBITAN TRIOLEATE HYDROLYZED JOJOBA ESTERS (ACID FORM) SODIUM ASCORBYL PHOSPHATE CELERY SEED FLAX SEED

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 - 60 mL Bottle Box VITAMIN C • 100% VEGAN • SOY-FREE • SPF 45 CRUELTY-FREE DERMA•E Vitamin C Weightless Moisturizer BROAD SPECTRUM SPF 45 Rooibos Vitamins B3 & E prime and brighten • DERMATOLOGIST • RECOMMENDED 2 FL OZ / 60 mL PRINCIPAL DISPLAY PANEL - 60 mL Bottle Box

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 DERMA E ® Simi Valley, CA 93065, USA

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 product is 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? Call toll free 1-800-933-9344 or visit dermae.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.

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 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.

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