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Prevention sun serum spf30 - Medication Information

Product NDC Code 62742-4225
Drug Name

Prevention sun serum spf30

Type Brand
Active Ingredients
Zinc oxide 15.6 g/100g
Route TOPICAL
Dosage Form CREAM
Application Number M020
Labeler Name Allure Labs
Packages
Package NDC Code Description
62742-4225-1 7 g in 1 tube (62742-4225-1)
62742-4225-3 1 tube in 1 carton (62742-4225-3) / 28.3 g in 1 tube (62742-4225-2)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Zinc Oxide 15.6%

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.
Shake well before use • apply generously 15 minutes before sun exposure • children under 6 months of age: Ask a doctor • reapply at least every 2 hours • use a water resistant sunscreen if swimming or sweating • 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

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients: ISODODECANE, SQUALANE, POLYSILICONE-11, PROPANEDIOL DICAPRYLATE/CAPRATE, POLYGLYCERYL-3 POLYRICINOLEATE, POLYHYDROXYSTEARIC ACID, TRIETHOXYCAPRYLYLSILANE, LECITHIN, TOCOPHERYL ACETATE, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, LIMONENE, CAMELLIA OLEIFERA SEED OIL, TETRAHEXYLDECYL ASCORBATE, PRUNUS ARMENIACA (APRICOT) KERNEL OIL, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, ALOE BARBADENSIS LEAF EXTRACT, CITRAL, LINALOOL, CITRIC ACID.

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.
Prevention Sun Serum SPF30 Zinc Oxide ORANGE OIL GINGER LIMONENE, (+)- TETRAHEXYLDECYL ASCORBATE CITRAL LINALOOL, (+/-)- ISODODECANE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) SAFFLOWER OIL CITRIC ACID MONOHYDRATE ZINC OXIDE ZINC OXIDE SQUALANE CAMELLIA OIL ALOE VERA LEAF PROPANEDIOL DICAPRYLATE/CAPRATE POLYHYDROXYSTEARIC ACID (2300 MW) TRIETHOXYCAPRYLYLSILANE POLYGLYCERYL-3 PENTARICINOLEATE LECITHIN, SOYBEAN .ALPHA.-TOCOPHEROL ACETATE APRICOT KERNEL OIL

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.
Prevention Sun Serum

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

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other information • protect the product in this container from excessive heat and direct sun

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