Invincible Setting Powder Spf 45 Translucent
FDA Label NDC 75936-145

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Taylor James, Ltd. for the product Invincible Setting Powder Spf 45 Translucent (NDC 75936-145). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredients      Purpose

Zinc Oxide 24.5%      Sunscreen           

Otc - Purpose

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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.  If product is swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage

Stop use and ask a doctor if rash occurs

Warnings

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.

Dosage & Administration

Directions

  • apply generously and evenly 15 minutes before sun exposure
    • reapply 
    • after 40 minutes of swimming or sweating
    • immediately 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 value of 15 or higher and other sun protections measures including:
    • Limit time in the sun, especially from 10a.m. -2p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses
    • Children under 6 months: Ask a doctor

Inactive Ingredient

Inactive Ingredients

Calcium Aluminum Borosilicate, Silica, Polymethyl Methacrylate, Ethylhexylglycerin, Triethoxycaprylysilane, Nylon-6/12, Sodium Dehydroacetate, Olive Glycerides, Ascorbyl Palmitate, Ceramide 3. May contain +/- Iron Oxides (CI 77492, CI 77491, CI 77499), Titanium Dioxide (CI 77891)

Package Label.Principal Display Panel

Invincible Setting Powder SPF 45

100% Mineral + Sweat resistant

Translucent

0.15 oz./ 4.25 g

Secondary (Invinciblepowder Secondary Translucent)

Secondary (Invinciblepowder Secondary Translucent)

Card (Invinciblepowder Card)

Card (Invinciblepowder Card)

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