Otc - Active Ingredient
Active Ingredients Purpose
Titanium Dioxide 14% Sunscreen
Zinc Oxide 6% Sunscreen
Clear Foundation Sunscreen Broad Spectrum Spf 45
FDA Label NDC 71014-012
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Eai-jr 286, Inc for the product Clear Foundation Sunscreen Broad Spectrum Spf 45 (NDC 71014-012). 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, warnings, dosage & administration, inactive ingredient, indications & usage, 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
- 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
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.
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 liberally and evenly 15 minutes before sun exposure and and at least every 2 hours
reapply: after 80 minutes of swimming or sweating
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 15 or higher and other 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
immediately after towel drying
Inactive Ingredient
Inactive Ingredients
Water, Dimethicone, Caprylic/Capric Triglyceride, Alumina, Lecithin, Stearic Acid, Isostearic Acid, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Squalane, Paraffin, Ceresin, Isononoyl Isononanoate, Microcrystalline Wax, Glycerin, Isopentyldiol, Polyethylene, HDI/Trimethylol Hexyllactone Crosspolymer, Polyglyceryl-6 Polyricinoleate, PEG-10 Dimethicone, Phenxoyethanol, Sodium Chloride, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Disteardimonium Hectorite, Triethoxycaprylylsilane, Disodium EDTA, Silica, Tocopherol.
Indications & Usage
Stop use and ask a doctor if:
rash or irritation develops and lasts
Package Label.Principal Display Panel
Vertra Elemental Resistance
Foundation Sunscreen Face Stick
Broad Spectrum SPF 45
Water Resistant (80 Minutes)
Color:Clear
11g NET WT. 0.39
* Please review the disclaimer below.
