Otc - Active Ingredient
Active Ingredients:
Titanium Dioxide 5.00%
Zinc Oxide 10.00%
Concealer Broad Spectrum Sunscreen Spf 30
FDA Label NDC 70698-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Epione Medical Corporation for the product Concealer Broad Spectrum Sunscreen Spf 30 (NDC 70698-004). 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 direct with other sun protection measures (see
Directions), decreases the risk of skin cancer and early aging caused by the sun.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get help or contact a Poison Control Center right away
Indications & Usage
Stop use/ contact a doctor if rash occurs
Warnings
Warnings:
For external use only
Do not use on damaged or broken skin
Avoid contact with eyes. Rinse with water to remove
Dosage & Administration
Directions:
Apply evenly 15 minutes before sun exposure
Reapply at least every 2 hours
Use a water resistant sunscreen if swimming or sweating
Children Under 6 months: Ask a doctor.
Sun Protection Measures:
Spending time in the sun increases the risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
limit time in the sun, especially from 10a.m.-2p.m.
Wear long-sleeved shirt, pants, hats, and sunglasses
Reapply at least every 2 hours
Inactive Ingredient
Water, Coconut Alkanes, Octyldodecyl Neopentanoate, Butylene Glycol, C12-15 Alkyl Benzoate, Polysorbate 60, Cyclopentasiloxane, Dimethicone, Cetearyl Alcohol, Glycerine, Polysorbate 60, Polyacrylamide, Polyhydroxystearic Acid, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, C13-14 Isoparaffin, Coco-Caprylate/Caprate, Stearic Acid, Acrylates/C10-30 Alklyl Acrylates Crosspolymer, Ethylhexylglycerin, Alumina, Xanthan Gum, Laureth-7, Triethanolamine, Iron Oxides( CI 77499, CI 77491, CI77492).
Package Label.Principal Display Panel
Epione
Concealer Broad Spectrum SPF 30+
1.0 FL OZ (30mL)
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