ANEW ULTIMATE DAY MULTI-PERFORMANCECREAM SPF 25 SUNSCREEN- avobenzone, homosalate, octinoxate,oxybenzone cream

ANEW ULTIMATE DAY MULTI-PERFORMANCECREAM SPF 25 SUNSCREEN by

Drug Labeling and Warnings

ANEW ULTIMATE DAY MULTI-PERFORMANCECREAM SPF 25 SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by COSMAX USA, CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

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

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.

Do not use on damaged or broken skin.

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

Stop use and ask a doctor if rash occurs.

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

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANEW ULTIMATE DAY MULTI-PERFORMANCECREAM SPF 25 SUNSCREEN 
avobenzone, homosalate, octinoxate,oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68577-190
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	8 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.85 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCOLIC ACID (UNII: 0WT12SX38S)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
HYDROGENATED POLYISOBUTENE (450 MW) (UNII: 7YR4ZFS62E)
TRISILOXANE (UNII: 9G1ZW13R0G)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
THIODIPROPIONIC ACID (UNII: 3BBK323ED8)
POLYSORBATE 60 (UNII: CAL22UVI4M)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
ISOHEXADECANE (UNII: 918X1OUF1E)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CARAMEL (UNII: T9D99G2B1R)
CYCLOTETRASILOXANE (UNII: CZ227117JE)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PALMITOYL TETRAPEPTIDE-10 (UNII: 6Q6H1PKC05)
BEHENYL ALCOHOL (UNII: 9G1OE216XY)
ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)
PHYTOL (UNII: 5BC2RZ81NG)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
THIAZOLYLALANINE (UNII: VTL1Y3S44B)
GLUCOSE (UNII: 5SL0G7R0OK)
ECLIPTA PROSTRATA LEAF (UNII: H86R96580E)
ISOMALT (UNII: S870P55O2W)
RED 4 (UNII: X3W0AM1JLX)
SODIUM LACTATE (UNII: TU7HW0W0QT)
STEARETH-20 (UNII: L0Q8IK9E08)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68577-190-00	1 in 1 CARTON	01/03/2024
1		50 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/03/2024

Labeler - COSMAX USA, CORPORATION (010990210)

Registrant - COSMAX USA, CORPORATION (010990210)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX USA, CORPORATION		010990210	manufacture(68577-190)