FDA.reportPublic FDA data

AVON Anew Ultimate Multi-Performance Day Cream SPF 25

Manufacturer
COSMAX USA, CORPORATION
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:47:12

Label at a glance#

ProductANEW ULTIMATE DAY MULTI-PERFORMANCECREAM SPF 25 SUNSCREEN
Active ingredientOCTINOXATE, HOMOSALATE, OXYBENZONE, AVOBENZONE
Label structure8 sections

Indications and 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

Dosage and administration

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 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 ...

Storage and handling

Other information • protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

AVOBENZONE 2.85%
HOMOSALATE 8.0%
OCTINOXATE 5.0%
OXYBENZONE 4.0%

OTC - PURPOSE SECTION

Purpose

Sunscreen

USES

INDICATIONS & USAGE SECTION

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 SECTION

Warnings

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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


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

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Other information

• protect the product in this container from excessive heat and direct sun

INACTIVE INGREDIENT SECTION

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

JARJARCARTONCARTON

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68577-190-00ANEW ULTIMATE DAY MULTI-PERFORMANCECREAM SPF 25 SUNSCREEN50 g in 1 JARCREAM501
68577-190-00ANEW ULTIMATE DAY MULTI-PERFORMANCECREAM SPF 25 SUNSCREEN1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68577-190ANEW ULTIMATE DAY MULTI-PERFORMANCECREAM SPF 25 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTINOXATE,OXYBENZONE) CREAM [COSMAX USA, CORPORATION]12 package rows20241222_29ad9cf5-0905-e7fd-e063-6394a90ad982.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68577-19068577-190-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 41 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCOLIC ACID0WT12SX38SIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
DIMETHICONE92RU3N3Y1OIACT
CETEARYL ALCOHOL2DMT128M1SIACT
PEG-100 STEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PEG-150 DISTEARATE6F36Q0I0ACIACT
HYDROGENATED POLYISOBUTENE (450 MW)7YR4ZFS62EIACT
TRISILOXANE9G1ZW13R0GIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
THIODIPROPIONIC ACID3BBK323ED8IACT
POLYSORBATE 60CAL22UVI4MIACT
MALTODEXTRIN7CVR7L4A2DIACT
ISOHEXADECANE918X1OUF1EIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
EDETATE DISODIUM7FLD91C86KIACT
CARAMELT9D99G2B1RIACT
OCTINOXATE4Y5P7MUD51ACTIB
HOMOSALATEV06SV4M95SACTIB
CYCLOTETRASILOXANECZ227117JEIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
POLYSORBATE 207T1F30V5YHIACT
PALMITOYL TETRAPEPTIDE-106Q6H1PKC05IACT
OXYBENZONE95OOS7VE0YACTIB
AVOBENZONEG63QQF2NOXACTIB
BEHENYL ALCOHOL9G1OE216XYIACT
ETHYLHEXYL ISONONANOATEI6KB4GE3K4IACT
PHYTOL5BC2RZ81NGIACT
SODIUM HYDROXIDE55X04QC32IIACT
DIMETHICONOL (2000 CST)T74O12AN6YIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
THIAZOLYLALANINEVTL1Y3S44BIACT
GLUCOSE5SL0G7R0OKIACT
ECLIPTA PROSTRATA LEAFH86R96580EIACT
ISOMALTS870P55O2WIACT
RED 4X3W0AM1JLXIACT
SODIUM LACTATETU7HW0W0QTIACT
STEARETH-20L0Q8IK9E08IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
561f0657-0664-45d7-e063-6294a90ac5b529ad9cf5-0905-e7fd-e063-6394a90ad9822026-07-08WarningsExact identifier
spl set id: 29ad9cf5-0905-e7fd-e063-6394a90ad982

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.