Otc - Active Ingredient
Active Ingredients
Octinoxate 7.11%....................................
Octisalate 4.75%.....................................
Avobenzone 2.00%.................................
Avon Elements
FDA Label NDC 10096-0300
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 Avon Elements (NDC 10096-0300). 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
Indications & Usage
Uses
- helps prevent sunburn
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
- apply generously and evenly 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, dimethicone, butylene glycol, glycerin, DI-C12-15 alkyl fumarate, pyridoxine HCL, zinc PCA, camellia sinensis leaf extract,dilauryl thiodipropionate, sodium hyaluronate, caprylic/capric triglyceride, dimethicone crosspolymer, silica, sorbitan isostearate, isohexadecane,
hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, acrylates/C10-30 alkyl acrylate crosspolymer, polysorbate 60, DNA, carbomer, sodium hydroxide, disodium EDTA, phenoxyethanol, methylparaben, propylparaben, caprylyl glycol, hexylene glycol, parfum/fragrance.
Otc - Questions
Questions or comments?
Call toll free 1-800-FOR-AVON
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