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Sunscreen - Medication Information

Product NDC Code 84118-002
Drug Name

Sunscreen

Type Generic
Active Ingredients
Titanium dioxide 100 mg/g
Route CUTANEOUS
Dosage Form LOTION
Application Number M020
Labeler Name Shenzhen Chengqi Electronic Science & Technology Co., Ltd.
Packages
Package NDC Code Description
84118-002-01 50 g in 1 bottle (84118-002-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
ACTIVE INGREDIENT : Titanium Dioxide 10% Ethylhexyl salicylate 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.
DOSAGE & ADMINISTRATION Take an appropriate amount of this product and apply it to the skin

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
INACTIVE INGREDIENT AQUA MINERAL OIL ETHYLHEXYL PALMITATE ACRYLATES COPOLYMER POLYACRYLAMIDE C13-14 ISOPARAFFIN LAURETH-7 TRIETHANOLAMINE PHENOXYETHANOL FRAGRANCE METHYLISOTHIAZOLINONE RETINOL BUTYLENE GLYCOL HYDROXYPROPYL CYCLODEXTRIN 1,2-HEXANEDIOL ETHYLHEXYLGLYCERIN

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.
Sunscreen Sunscreen 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 Label

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 swallwed, 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 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