Otc - Active Ingredient
Active ingredients
OCTINOXATE 7.11%, OCTISALATE 4.75%,
OXYBENZONE 4.00%, AVOBENZONE 2.85%.............................................................
The following Structured Product Label (SPL) was submitted to the FDA by Avon Products, Inc for the product Anew Reversalist (NDC 10096-0181). 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 7.11%, OCTISALATE 4.75%,
OXYBENZONE 4.00%, AVOBENZONE 2.85%.............................................................
Purpose
.....................................Sunscreen
Uses• 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
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 ingredients: WATER/EAU, DIMETHICONE, GLYCERIN, BUTYLENE GLYCOL,
ISODECYL ISONONANOATE, TROMETHAMINE, DILAURYL THIODIPROPIONATE, PHYTOL,
THIODIPROPIONIC ACID, THIAZOLYLALANINE, SESBANIA GRANDIFLORA FLOWER EXTRACT,
AMORPHOPHALLUS CAMPANULATUS RHIZOME/ROOT EXTRACT, PUNICA GRANATUM FRUIT
JUICE, PALMITOYL LYSYL AMINOVALEROYL LYSINE, TOCOPHEROL, POLYSORBATE 20,
CETEARYL ALCOHOL, KAEMPFERIA GALANGA ROOT EXTRACT, ISOHEXADECANE,
CARBOMER, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, NYLON-12,
POLYMETHYLSILSESQUIOXANE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL
TAURATE COPOLYMER, XANTHAN GUM, CETEARETH-20, HYDROGENATED LECITHIN, SILICA,
POLYSORBATE 60, TRIMETHYLSILOXYSILICATE, SORBITAN ISOSTEARATE, DIMETHICONE
CROSSPOLYMER, POLYMETHYL METHACRYLATE, ETHYLHEXYLGLYCERIN, DISODIUM EDTA,
PHENOXYETHANOL, PARFUM/FRAGRANCE.
Questions? Call 1-800-FOR-AVON
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