Otc - Active Ingredient
Active ingredients Purpose
Titanium Dioxide 15.7% Sunscreen
Zinc Oxide 20% Sunscreen
Invincible Setting Powder Spf 45
FDA Label NDC 75936-105
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 (NDC 75936-105). 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 - 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
Indications & Usage
Stop use and ask a doctor if rash occurs
Warnings
Warnings For external use only
Do not on damaged or broken skin
When using this product keep out of eyes
Rinse with water to remove
If swallowed, get medical help or contact a Poison Center right away
Dosage & Administration
Directions Apply liberally and evenly to face before sun exposure
Reapply after 40 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours
Children under 6 months: Ask a doctor
Inactive Ingredient
Inactive Ingredients Silica, Calcium Aluminum Borosilicate, Polymethyl Methacrylate, Lauroyl Lysine, Phenoxyethanol, Water (Aqua), Sodium Dehydroacetate, Ascorbyl palmitate, Ceteareth-25, Glycerin, Cetyl Alcohol, Cholesterol, Ceramide NP, Behenic Acid, Ethylhexyglycerin, Ceramide NS, Ceramide AP, Ceramide EOP, Ceramide EOS, Caprooyl Pytosphingosine, Caprooyl Sphingosine, Tocopherol, Titanium Dioxide (CI77891), Iron Oxides (CI 77491)
Package Label.Principal Display Panel
Invincible Setting Powder
SPF 45
100% mineral. Sweat Resistant
0.09 oz / 2.5 g
* Please review the disclaimer below.
