The following Structured Product Label (SPL) was submitted to the FDA by New Avon Llc for the product Anew Men (NDC 10096-0326). 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
Avobenzone 2.8%...........................
Homosalate 9.5%...........................
Octinoxate 7.5%............................
Octocrylene 2.56%.......................
Oxybenzone 4.75%........................
Purpose
.................Sunscreen
.................Sunscreen
................Sunscreen
................Sunscreen
..............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
For sunscreen use:
• 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
Inactive ingredients
water/eau, propanediol, butyloctyl salicylate, dimethicone, dilauryl thiodipropionate, polymethylsilsesquioxane, silica, ceteareth-20,cocos nucifera (coconut) seed butter, glycerin, PEG-8, polysilicone-11, phenoxyethanol, stearoxytrimethylsilane, cetearyl alcohol, ceteth-2, hydrogenated lecithin, stearyl alcohol, caprylyl glycol, hydrolyzed wheat protein, hydroxyethyl acrylate/sodium acryloyldimethyl taurate
copolymer, isohexadecane, tromethamine, carbomer, disodium edta, oryzanol, phyllanthus emblica fruit extract, phytol, hydrolyzed wheat
starch, polysorbate 60, laureth-12, camellia sinensis leaf extract, caprylic/capric triglyceride, cinnamido benzylpiperidinyl ethoxypropylbenzamide, retinol/saccharomyces polypeptide, phaeodactylum tricornutum extract, tocopherol.
Questions?
1-800-FOR-AVON or 1-800-265-AVON in Canada
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