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Sunforgettable total protection sheet matte sunscreen spf 30 - Medication Information

Product NDC Code 68078-036
Drug Name

Sunforgettable total protection sheet matte sunscreen spf 30

Type Brand
Active Ingredients
Zinc oxide 225 mg/g
Route TOPICAL
Dosage Form POWDER
Application Number part352
Labeler Name Colorescience
Packages
Package NDC Code Description
68078-036-01 1 tube, with applicator in 1 carton (68078-036-01) / 4.3 g in 1 tube, with applicator
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Zinc Oxide 22.5%

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 a water resistant sunscreen if swimming or sweating. 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 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.
Inactive ingredients Mica, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol/Propylsilsequioxane/Silicate Crosspolymer, Methicone, Maltodextrin, Silica, Glycerin, Club Moss (Lycopodium Clavatum) Extract, Sodium Hyaluronate, Grape (Vitis Vinifera) Seed Extract, Green Tea (Camellia Sinensis) Leaf Extract, Oak (Quercus Robur) Wood Extract, Cogon Grass (Imperata Cylindrica) Root Extract, Water, Tara (Caesalpinia Spinosa) Fruit Pod Extract, Sunflower (Helianthus Annuus) Sprout Extract, Isoceteth-10, Triethoxycaprylylsilane, Sodium Benzoate, Potassium Sorbate, Iron Oxides (CI77491, CI 77492, CI 77499).

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.
Sunforgettable Total Protection Sheet Matte Sunscreen SPF 30 Zinc Oxide Zinc Oxide Zinc Oxide Mica DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) METHICONE (20 CST) Maltodextrin SILICON DIOXIDE Glycerin Isoceteth-10 HYALURONATE SODIUM VITIS VINIFERA SEED GREEN TEA LEAF QUERCUS ROBUR TWIG BARK IMPERATA CYLINDRICA ROOT Water CAESALPINIA SPINOSA RESIN SUNFLOWER OIL Sodium Benzoate Potassium Sorbate Triethoxycaprylylsilane FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE FERRIC OXIDE RED

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 - 4.3 g Tube Carton colorescience ® SUNFORGETTABLE ® TOTAL PROTECTION™ SHEER MATTE SUNSCREEN + Protects from UVA/UVB, pollution, blue light, IR + Absorbs excess oil, mattifies + Mess-free application 30 Broad Spectrum SPF 30 Sunscreen PA+++ CHEMICAL-FREE ACTIVES | 100% MINERAL Net Wt. 4.3 g / 0.15 oz. Principal Display Panel - 4.3 g Tube Carton

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 in USA by colorescience ® Carlsbad, CA 92011

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? Call toll free 866.426.5673

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 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