Otc - Active Ingredient
Active Ingredients
Octinoxate 7.5%......................
Oxybenzone 3.0%...................
Octisalate 3.0%......................
Avobenzone 2.0% ..................
The following Structured Product Label (SPL) was submitted to the FDA by New Avon Llc for the product Skin So Soft Firm And Restore (NDC 10096-0331). 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 Ingredients
Octinoxate 7.5%......................
Oxybenzone 3.0%...................
Octisalate 3.0%......................
Avobenzone 2.0% ..................
Purpose
................ Sunscreen
................ Sunscreen
................. Sunscreen
.................. Sunscreen
Uses
■ helps prevent sunburn
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
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
For sunscreen use:
■ apply generously and evenly 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
Other Information
■ protect the product in this container from excessive heat and direct sun.
Inactive ingredients: WATER/EAU, GLYCERIN, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, CETYL ALCOHOL, PARFUM/FRAGRANCE, PEG-40 STEARATE, PROPYLENE GLYCOL, STEARETH-2, THIODIPROPIONIC ACID, ETHOXYDIGLYCOL, SODIUM HYDROXIDE, DIMETHICONE, CARBOMER, STEARYL ALCOHOL, HYDROGENATED POLYDECENE, PHENOXYETHANOL, CAPRYLYL GLYCOL, SILICA, DISODIUM EDTA, XANTHAN GUM, TRIMETHYLSILOXYSILICATE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, DIMETHICONE CROSSPOLYMER, ORBIGNYA OLEIFERA SEED OIL, LECITHIN, ETHYLENE/METHACRYLATE COPOLYMER, GLYCINE SOJA (SOYBEAN) OIL, CAFFEINE, PHOSPHORIC ACID, ISOPROPYL TITANIUM TRIISOSTEARATE, TOCOPHEROL, ALGAE EXTRACT.
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