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Lani and kai mineral sunscreen spf30 - Medication Information

Product NDC Code 71447-052
Drug Name

Lani and kai mineral sunscreen spf30

Type Brand
Active Ingredients
Titanium dioxide 2 g/100g
Zinc oxide 18.4 g/100g
Route TOPICAL
Dosage Form CREAM
Application Number part352
Labeler Name LABORATOIRES DRUIDE INC
Packages
Package NDC Code Description
71447-052-01 1 bottle, plastic in 1 box (71447-052-01) / 50 g in 1 bottle, plastic (71447-052-00)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Titanium Dioxide 2% Zinc Oxide 18.4%

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 and evenly 15 minutes before sun exposure ▪ Reapply ▪ After 80 minutes of swimming or sweating ▪ Immediately after towel drying ▪ At least every 2 hours ▪ 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 ▪ Use a water-resistant sunscreen if swimming or sweating.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients C10-18 Triglycerides, Sodium Citrate, Sorbic Acid, Tocopherol, Potassium Sorbate, Sodium Stearoyl Glutamate, Aloe Barbadensis Leaf Juice, Coco-Caprylate, Alumina, Glycerin, Stearic Acid, Xanthan Gum, Lecithin, Polyhydroxystearic Acid, Polyglycery 3 Polyricinoleate, Salicylic Acid, Benzyl Alcohol, Isostearic Acid, Coconut Extract, Caprylic/Capric/ Linoleic Triglyceride, Glyceryl Stearat.

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.
LANI AND KAI MINERAL SUNSCREEN SPF30 TITANIUM DIOXIDE, ZINC OXIDE CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE GLYCERYL STEARATE SE C10-18 TRIGLYCERIDES SODIUM CITRATE SORBIC ACID TOCOPHEROL PROPANEDIOL POTASSIUM SORBATE SODIUM STEAROYL GLUTAMATE ALOE VERA LEAF COCO-CAPRYLATE ALUMINUM OXIDE GLYCERIN STEARIC ACID XANTHAN GUM LECITHIN, SUNFLOWER POLYHYDROXYSTEARIC ACID (2300 MW) POLYGLYCERYL-3 RICINOLEATE SALICYLIC ACID BENZYL ALCOHOL ISOSTEARIC ACID COCONUT TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE

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.
LANI AND KAI SPF30 MINERAL SUNSCREEN 50G (NDC 71447-050-00) Lani & Kai SPF 30 Mineral Sunscreen 50 g

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 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? 1-844-311-6652 or visit www.laniandkai.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.

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