Otc - Active Ingredient
Active Ingredients
AVOBENZONE 2.85%
HOMOSALATE 8.0%
OCTINOXATE 5.0%
OXYBENZONE 4.0%
Anew Ultimate Day Multi-performancecream Spf 25 Sunscreen Cream
FDA Label NDC 68577-190
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cosmax Usa, Corporation for the product Anew Ultimate Day Multi-performancecream Spf 25 Sunscreen (NDC 68577-190). 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, uses, 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
Uses
Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decrease 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.
Directions
Directions
For sunscreen use:
- apply liberally 15 minutes before sun exposure
- children less than 6 months of age: ask a doctor
- reapply at least every 2 hours
- use a water resistant sunscreen if swimming or sweating
- limit time in the sun, especially from 10 a.m. – 2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
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:
Other Information
Other information
• protect the product in this container from excessive heat and direct sun
Inactive Ingredient
Inactive Ingredients:
WATER, DIMETHICONE, GLYCERIN, BUTYLENE GLYCOL, GLYCOLIC ACID, BEHENYL ALCOHOL, HYDROGENATED POLYISOBUTENE, TRISILOXANE, ETHYLHEXYL ISONONANOATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, CETEARYL ALCOHOL, ISOHEXADECANE, PHYTOL, THIODIPROPIONIC ACID, SODIUM HYDROXIDE, PEG-100 STEARATE, FRAGRANCE, DIMETHICONOL, PHENOXYETHANOL, CETEARYL GLUCOSIDE, POLYSORBATE 60, DISODIUM EDTA, PEG-150 DISTEARATE, SORBITAN ISOSTEARATE, MALTODEXTRIN, TILIACORA TRIANDRA LEAF/VINE EXTRACT, CARAMEL, THIAZOLYLALANINE, CYCLOTETRASILOXANE, GLUCOSE, ECLIPTA PROSTRATA EXTRACT, ISOMALT, RED 4 (CI 14700), SACCHAROMYCES/COPPER FERMENT, SACCHAROMYCES/MAGNESIUM FERMENT, SACCHAROMYCES/MALACHITE FERMENT, SACCHAROMYCES/TOURMALINE FERMENT, SACCHAROMYCES/ZINC FERMENT, CARBOMER, SODIUM LACTATE, POLYSORBATE 20, STEARETH-20, LECITHIN, VITIS VINIFERA (GRAPE) FRUIT CELL EXTRACT, PALMITOYL TETRAPEPTIDE-7, PALMITOYL LYSYL AMINOVALEROYL LYSINE, PALMITOYL TETRAPEPTIDE-10
Package Label.Principal Display Panel
Jar (Avon Anewultimate Pp)
Carton (Avon Anewultimate Sp)
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