Otc - Active Ingredient
Active/Medicinal Ingredient
Titanium Dioxide 5.39% W/W............
Extralasting
FDA Label NDC 10096-0232
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by New Avon Llc for the product Extralasting (NDC 10096-0232). 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, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
......................................Sunscreen
Indications & Usage
Uses
helps prevent sunburn
Warnings
Warnings
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
For external use only
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
• apply liberally 15 minutes before sun exposure
• children under 6 months of age: ask a doctor
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
Storage And Handling
Other information
• protect the product in this container from excessive heat and direct sun
Inactive Ingredient
Inactive/non-medicinal ingredients: Water/Eau, Cyclopentasiloxane, Dimethicone, Dipropylene Glycol, Glycerin, PEG-10 Dimethicone, Nylon-12, Polymethyl Methacrylate, Trisiloxane, Methyl Trimethicone, Acrylates/Dimethicone Copolymer, Sodium Chloride, Quaternium-90 Bentonite, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Aluminum Hydroxide, Caprylyl Glycol, Stearic Acid, Phenoxyethanol, Tetrasodium EDTA, Propylene Carbonate, Hexylene Glycol, Cellulose, Trifluoromethyl C1-4 Alkyl Dimethicone, Parfum/Fragrance, Triethoxycaprylylsilane, Glyceryl Rosinate, Octyldodecyl Myristate. May Contain: Titanium Dioxide/CI 77891, Iron Oxides.
Otc - Questions
Questions or Comments?
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