Anew
FDA Label NDC 10096-0266

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Avon Products, Inc. for the product Anew (NDC 10096-0266). 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 - ask doctor, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active ingredientsHOMOSALATE 8%, OCTINOXATE 5%, OXYBENZONE 4%,AVOBENZONE 2.85%...................................................................

Otc - Purpose

                                          Purpose
....................................................Sunscreen

Indications & Usage

Uses
• helps prevent sunburn

• if used as directed with other sun protection measures (see Directions), decreases the risk of 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 - Ask Doctor

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 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

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, GLYCOLIC ACID, GLYCERIN, BEHENYL ALCOHOL, HYDROGENATED POLYISOBUTENE, TRISILOXANE, ETHYLHEXYL ISONONANOATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, CETEARYL ALCOHOL, ISOHEXADECANE, PHYTOL, THIODIPROPIONIC ACID, VITIS VINIFERA (GRAPE) FRUIT CELL EXTRACT, MALUS DOMESTICA FRUIT CELL CULTURE EXTRACT, ECLIPTA PROSTRATA EXTRACT, PALMITOYL LYSYL AMINOVALEROYL LYSINE, PALMITOYL TETRAPEPTIDE-10, PALMITOYL TETRAPEPTIDE-7, MELICOPE HAYESII LEAF EXTRACT, SACCHAROMYCES FERMENT LYSATE FILTRATE, THIAZOLYLALANINE, MESYLOXYBENZYL ISOBUTYLBENZENESULFONAMIDE, PEG-100 STEARATE, CETEARYL GLUCOSIDE, DIMETHICONOL, POLYSORBATE 60, PEG-150 DISTEARATE, XANTHAN GUM, ISOMALT, LECITHIN, STEARETH-20, AMMONIUM HYDROXIDE, PHENOXYETHANOL, DISODIUM EDTA, PARFUM/FRAGRANCE, CARAMEL, RED 4/CI 14700.

Otc - Questions

Questions? 1-800-FOR-AVON

* Please review the disclaimer below.