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Translucent broad spectrum foundation spf 50 vertra - Prescription Drug Labeling

Product NDC Code 71014-005
Drug Name

Translucent broad spectrum foundation spf 50 vertra

Type Brand
Active Ingredients
Padimate o 7 g/100g
Titanium dioxide 17.45 g/100g
Route TOPICAL
Dosage Form STICK
Application Number part352
Labeler Name Eai-Jr286, Inc.
Packages
Package NDC Code Description
71014-005-02 1 cylinder in 1 box (71014-005-02) > 10.5 g in 1 cylinder (71014-005-01)

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Purpose Padamite O 7% Sunscreen Titanium Dioxide 17%

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 apply to all skin exposed to sun use a water resistant sunscreen if swimming or sweating reapply: after 80 minutes of swimming or sweating immeadiately 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 otther sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses children under 6 months of age: ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Hexyldecyl Isosterate, Mica, Synthetic wax, Paraffin, Ozokerite, Polyglyceryl-2 Oleate, Aluminum Hydroxide, Stearic Acid, Ethylene/Propylene Copolymer, Tocopheryl, Fragrance, Iron Oxides

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 measures (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.
Translucent Broad Spectrum Foundation SPF 50 Vertra Padimate O, Titanium Dioxide PADIMATE O PADIMATE O TITANIUM DIOXIDE TITANIUM DIOXIDE ALUMINUM HYDROXIDE HEXYLDECYL ISOSTEARATE MICA CERESIN PARAFFIN STEARIC ACID SYNTHETIC WAX (1200 MW) TOCOPHEROL

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 Elemental Resistance Foundation Sunscreen Face Stick Broad Spectrum SPF 50+ Water Resistant (80 minutes) Color: Translucent 10.5g NET WT. .37 oz. Translucent SPF 50 updated box Translucent SPF 50 updated stick

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 products is swallowed, get medical help or contact 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 For external use only Do not use on damaged or broken skin When using this product keep out of eyes Rinse with water to remove

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