Otc - Active Ingredient
Active Ingredients
Homosalate 8.0%............................
Octinoxate 5.0%..............................
Oxybenzone 4.0%.........................
Avobenzone 2.85%...........................
Anew Vitale
FDA Label NDC 10096-0322
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 Anew Vitale (NDC 10096-0322). 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
............... Sunscreen
.............. Sunscreen
.............. Sunscreen
Indications & Usage
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
Warnings
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
For sunscreen use:
- apply liberally 15 minutes before sun exposure
- children under 6 month 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
Storage And Handling
Other Information
- protect the product in this container from excessive heat and direct sun
Inactive Ingredient
Inactive ingredients:
water/eau, butylene glycol, dimethicone, PEG-8, trisiloxane, glycerin, ethylhexyl isononanoate, HDI/trimethylol hexyllactone crosspolymer,
cetyl alcohol, caprylyl glycol, behenyl alcohol, dilauryl thiodipropionate, thiodipropionic acid, carbomer, glyceryl stearate, parfum/fragrance,
sodium hydroxide, phenoxyethanol, trimethylsiloxysilicate, hydrogenated lecithin, acrylates/C10-30 alkyl acrylate crosspolymer, disodium
EDTA, polyglyceryl-3 diisostearate, choleth-24, hexylene glycol, ceteth-24, panthenol, silica, mesyloxybenzyl methoxyethyl chlorobenzamide,
pichia ferment lysate filtrate, saccharomyces ferment lysate filtrate, palmitoyl tetrapeptide-10.
Otc - Questions
Questions?
1-800-FOR-AVON or 1-800-265-AVON in Canada
Package Label.Principal Display Panel
Image Of Pdp (Pdp)
Image Of Carton (Dfb1)
Image Of Carton (Dfb2)
Image Of Carton (Dfb3)
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