Otc - Active Ingredient
Active ingredient
Titanium Dioxide 5.40% W/W................................
The following Structured Product Label (SPL) was submitted to the FDA by New Avon Llc for the product Ideal Flawless (NDC 10096-0293). 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.
Active ingredient
Titanium Dioxide 5.40% W/W................................
Purpose
.................................Sunscreen
Uses
• helps prevent sunburn
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.
Stop use and ask a doctor if rash occurs
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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
• 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 of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m. – 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses
Other information
• protect the product in this container from excessive heat and direct sun
Inactive/Non-Medicinal Ingredients:
Water/Eau, Cyclopentasiloxane, Phenyl Trimethicone, Glycerin, Butylene Glycol, PEG-10 Dimethicone, Dimethicone, Sodium Chloride, Trifluoromethyl C1-4 Alkyl Dimethicone, Nylon-12, Octyldodecyl Neopentanoate, Polysilicone-11, Quaternium-90 Bentonite, Aluminum Hydroxide, Caprylyl Glycol, Stearic Acid, Octyldodecyl Stearoyl Stearate, Phenoxyethanol, Methyl Undecylenate, Ethyl Undecylenate, HDI/Trimethylol Hexyllactone Crosspolymer, Tetrasodium EDTA, Triethoxysilylethyl Polydimethylsiloxyethyl Dimethicone, Propylene Carbonate,
Hexylene Glycol, Calcium PCA, Zinc PCA, Hexyl Laurate, Cetyl PEG/PPG-10/1 Dimethicone, Polyglyceryl-4 Isostearate, Methicone, Cocos Nucifera (Coconut) Fruit Juice, Silica, Tocopheryl Acetate, Saccharomyces/Copper Ferment, Saccharomyces/Magnesium Ferment, Saccharomyces/Zinc Ferment, Saccharomyces/Malachite Ferment, Saccharomyces/Tourmaline Ferment. May Contain: Titanium Dioxide/CI 77891, Iron Oxides, Mica/CI 77019.
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