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Tulip dew sunscreen - Medication Information

Product NDC Code 82548-4530
Drug Name

Tulip dew sunscreen

Type Brand
Pharm Class Copper Absorption Inhibitor [EPC],
Decreased Copper Ion Absorption [PE]
Active Ingredients
Zinc oxide 120 mg/ml
Route TOPICAL
Dosage Form LOTION
Application Number M020
Labeler Name Bloomeffects, Inc.
Packages
Package NDC Code Description
82548-4530-1 1 bottle, pump in 1 carton (82548-4530-1) / 55 ml in 1 bottle, pump
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Zinc Oxide 12% 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.
Directions Apply liberally 15 minutes before sun exposure REAPPLY : use a water-resistant sunscreen if swimming or sweating at least every 2 hours 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 & other sun protection measures including: Sun Protection Measures limit your time in the sun, especially from 10 a.m – 2 p.m. wear long-sleeved shirts, pants, hats and sunglasses Children under 6 months of age: ask a doctor. Shake well

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients: Water (Aqua), C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Jojoba Esters, Tridecyl Salicylate, Propanediol, Polyglyceryl-4 Disostearate/Polyhydroxystearates/Sebacate, Niacinamide, Methylpropanediol, Silica, Nylon-12, Coco-Caprylate, Tulipa Gesneriana/Kaurmanniana Meristem Cell Lysate Filtrate Extract, Helianthus Annuus Extract, Glycerin, Sodium Hyaluronate, Sodium Lactate, Bisabolol, Allantoin, Oryza Sativa Bran Extract, Terminalia Ferdinandiana Fruit Extract, Podocarpus Elatus Fruit Extract, Pleiogynium Timoriense Fruit Extract, Lecithin, Hydrogenated Lecithin, Leuconostoc/Radish Root Ferment Filtrate, Rosmarinus Officinalis Leaf Extract, Sodium Chloride, Polyglyceryl-2 Dipolyhydroxystearate, Caprylyl Glycol, Methylheptyl Isostearate, Phenylpropanol, Tetrasodium Glutamate Diacetate, Sodium Gluconate, Pentylene Glycol, Sodium Hydroxide, Phenethyl Alcohol, Potassium Sorbate, Alcohol, Hamamelis Virginiana Water, Citric Acid, CI 77499, CI 77492, CI 77491.

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 ), decreases the risk of skin cancer & early skin aging caused by the sun. Directions

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.
Tulip Dew Sunscreen ZINC OXIDE WATER ALKYL (C12-15) BENZOATE MEDIUM-CHAIN TRIGLYCERIDES TRIDECYL SALICYLATE PROPANEDIOL POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE NIACINAMIDE METHYLPROPANEDIOL SILICON DIOXIDE NYLON-12 COCO-CAPRYLATE GLYCERIN HYALURONATE SODIUM SODIUM LACTATE LEVOMENOL ALLANTOIN KAKADU PLUM PODOCARPUS ELATUS FRUIT PLEIOGYNIUM TIMORIENSE FRUIT LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE ROSEMARY SODIUM CHLORIDE POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE CAPRYLYL GLYCOL METHYLHEPTYL ISOSTEARATE PHENYLPROPANOL TETRASODIUM GLUTAMATE DIACETATE SODIUM GLUCONATE PENTYLENE GLYCOL SODIUM HYDROXIDE PHENYLETHYL ALCOHOL POTASSIUM SORBATE ALCOHOL CITRIC ACID MONOHYDRATE FERROSOFERRIC OXIDE FERRIC OXIDE YELLOW FERRIC OXIDE RED ZINC OXIDE ZINC CATION

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.
Package Labeling: Label

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 Other information Protect the product in this container from excessive heat and direct sun.

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.

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 & ask a doctor if skin 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. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use & ask a doctor if skin 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