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One and done - Medication Information

Product NDC Code 82735-200
Drug Name

One and done

Type Brand
Active Ingredients
Titanium dioxide 2 g/100ml
Zinc oxide 1 g/100ml
Route TOPICAL
Dosage Form CREAM
Application Number part352
Labeler Name Thirteen Lune Inc.
Packages
Package NDC Code Description
82735-200-01 50 ml in 1 tube (82735-200-01)
82735-200-02 15 ml in 1 tube (82735-200-02)
82735-200-03 4 ml in 1 packet (82735-200-03)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient ZINC OXIDE 1% TITANIUM DIOXIDE 2%

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. Sun Protection Measures. Spending time in the sun increased your risk of skin cancer and early skin aging. To decrease this rick, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measure including: Limit time in the sun, especially from 10 a.m. - 2p.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 Water, Butyloctyl Salicylate, Octyldodecyl Neopentanoate, Ethylhexyl Isononanoate, Polyester-7, Glycerin, Neopentyl Glycol Diheptanoate, Niacinamide, Cetyl Alcohol, Glyceryl Stearate, Squalane, PEG-75 Stearate, Phenoxyethanol, Bisabolol, Hydrolyzed Sodium Hyaluronate, Pyrus Malus (Apple) Fruit Extract, C12-15 Alkyl, Benzoate, Lysolecithin, Sclerotium Gum, Dimethiconol/Caprylylsilsesquioxane/Silicate Crosspolymer, Allantoin, Caprylyl Glycol, Hippophae Rhamnoides Seed Oil, Prunus, Domestica Seed Oil, Mauritia Flexuosa Fruit Oil, Triceteareth-4 Phosphate, Pullulan, Xanthan Gum, Ceteth-20, Steareth-20, Ethylhexylglycerin, Hexylene Glycol, Sodium Hyaluronate, Trilaureth-4 Phosphate, Butylene Glycol, Disodium EDTA, Dimethiconol/Propylsilsesquioxane/Silicate Crosspolymer, Plankton Extract, Lecithin, Silica, Avena Sativa (Oat) Kernel Extract, Kigelia Africana Fruit Extract, Camellia Sinensis Leaf Extract, Potassium Sorbate, Sodium Ascorbate, Tocopherol.

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), decrease the risk of skin cancer and early skin againg 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.
One and Done SPF 40 ZINC OXIDE ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE WATER

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 50ML RELEVANT ONE + DONE 50ML 15ML RELEVANT ONE + DONE SPF 4ML RELEVANT ONE + DONE SACHET (SAMPLE) Primary Packaging Artwork 15ML PRIMARY PACKAGING ARTWORK 4ML PRIMARY PACKAGING ARTWORK

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.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions (888) 305-2032

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. Keep outer carton for complete labeling information.

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