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Belli pure radiance facial sunscreen tinted protection spf 25 - Medication Information

Product NDC Code 42281-003
Drug Name

Belli pure radiance facial sunscreen tinted protection spf 25

Type Brand
Active Ingredients
Titanium dioxide 70 mg/ml
Zinc oxide 50 mg/ml
Route TOPICAL
Dosage Form CREAM
Application Number M020
Labeler Name BODY HALO LLC
Packages
Package NDC Code Description
42281-003-01 1 bottle, pump in 1 carton (42281-003-01) / 44 ml in 1 bottle, pump
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Titanium Dioxide (7%) Zinc Oxide (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 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 apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours children under 6 months: ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Butylene Glycol, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Cetyl Alcohol, Cyclomethicone, Deionized Water, Glycereth-2 Cocoate, Glycerine, Glyceryl Stearate, Hydrolyzed Collagen (Marine Derived) Iodopropynyl Butylcarbamate, Iron Oxides, Isopropyl Palmitate, Octyldodecyl Neopentanoate, PEG-100 Stearate, Phenoxyethanol, Polyglyceryl-2 Diisostearate, Sodium PCA, Tocopheryl Acetate (Vitamin E), Xanthan Gum

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.
Belli Pure Radiance Facial Sunscreen Tinted Protection SPF 25 TITANIUM DIOXIDE, ZINC OXIDE BUTYLENE GLYCOL ALKYL (C12-15) BENZOATE POLYOXYL 20 CETOSTEARYL ETHER CETOSTEARYL ALCOHOL CETYL ALCOHOL CYCLOMETHICONE WATER GLYCERETH-2 COCOATE GLYCERIN GLYCERYL MONOSTEARATE MARINE COLLAGEN, SOLUBLE IODOPROPYNYL BUTYLCARBAMATE FERRIC OXIDE RED ISOPROPYL PALMITATE OCTYLDODECYL NEOPENTANOATE PEG-100 STEARATE PHENOXYETHANOL POLYGLYCERYL-2 DIISOSTEARATE SODIUM PYRROLIDONE CARBOXYLATE .ALPHA.-TOCOPHEROL ACETATE XANTHAN GUM 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.
Inner Label Outer 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.
Other information Store below 25 degree C/77 degree F.

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. In case of accidental ingestion, contact a Poison Control Center immediately.

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 or skin irritation develops and lasts

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. When using this product keep out of eyes rinse with water to remove Stop use and ask a doctor if rash or skin irritation develops and lasts Keep out of reach of children. In case of accidental ingestion, contact a Poison Control Center immediately.

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