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Vertra pearl white face stick spf 50 - Prescription Drug Labeling

Product NDC Code 66990-1019
Drug Name

Vertra pearl white face stick spf 50

Type Brand
Active Ingredients
Padimate o 7 g/100g
Titanium dioxide 17 g/100g
Route TOPICAL
Dosage Form STICK
Application Number part352
Labeler Name Toshiki Pigment Co., ltd.
Packages
Package NDC Code Description
66990-1019-1 10.5 g in 1 carton (66990-1019-1)

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Purpose PADIMATE O 7% Sunscreen TITANIUM DIOXIDE 17% 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 and generously 15 minutes before sun exposure and at least every 2 hours Children under 6 months of age: ask a doctor. 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 your time in the sun, especially from 10 a.m. – 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses Reapply: After 80 minutes of swimming or sweating Immediately after towel drying at least every 2 hours

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Hexyldecyl Isostearate, Mica, Synthetic Wax, Paraffin, Ozokerite, Polyglyceryl-2 Oleate, Aluminum Hydroxide, Stearic Acid, Ethylene/Propylene Copolymer, Tocopherol, Fragrance

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.
Stop use and ask a doctor if: Rash or irritation develops and lasts

Purpose

Information about the drug product’s indications for use.
Uses Helps prevent sunburn If used as directed with other sun protection (see directions), decreases the risk of skin cancer and early skin aging caused by the sun. Higher SPF gives more sunburn protection Retains SPF after 80 minutes activity in the water, sweating, or perspiring. Provides high protection against sunburn

Spl product data elements

Usually a list of ingredients in a drug product.
Vertra Pearl White Face Stick SPF 50 Padimate O, Titanium Dioxide PADIMATE O PADIMATE O TOCOPHEROL PARAFFIN HEXYLDECYL ISOSTEARATE SYNTHETIC WAX (1200 MW) POLYGLYCERYL-2 OLEATE ALUMINUM HYDROXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE MICA CERESIN STEARIC ACID

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.
Vertra Premium Suncare SPF 50 + Premium Mineral Based Foundation Sunscreen Face Stick Reef Safe Broad Spectrum SPF 50+ Water Resistant (80 Minutes) Color: Pearl white 10.5g NET WT 0.37 OZ 2021 Pearl White SPF 50

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 product is swallowed get medical help or contact a Poison Control Center right away

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 Do not use: On damaged or broken skin When using this product: keep out of eyes. Rinse with water to remove For external use only

Disclaimer: Do not rely on openFDA 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