ANEW PLATINUM DAYCREAM BROAD SPECTRUM SPF 25- avobenzone, octinoxate, octisalate, oxybenzone cream

Anew Platinum DayCream Broad Spectrum SPF 25 by

Drug Labeling and Warnings

Anew Platinum DayCream Broad Spectrum SPF 25 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

OCTINOXATE 7.5%

OCTISALATE 4.8%

OXYBENZONE 4%

AVOBENZONE 2.9%

PURPOSE

Purpose

Sunscreen

USES

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and skin aging caused by the sun

WARNINGS

Warnings

For external use only

Do not use on damaged 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

• 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

the product may stain certain types of fabrics

INACTIVE INGREDIENT

Inactive Ingredients:

WATER, GLYCERIN, SILICA, DIMETHICONE, STEARIC ACID, STEARYL ALCOHOL, NONENOL, SAPINDUS RARAK FRUIT EXTRACT, POUZOLZIA PENTANDRA EXTRACT, METHOXYBENZOYL METHYLSULFONYL OXOPIPERIDINYL PIPERAZINECARBOXAMIDE, THIAZOLYLALANINE, TRISILOXANE, DIMETHICONOL, MYRISTYL MYRISTATE, MALTODEXTRIN, PEG-100 STEARATE, CAPRYLYL GLYCOL, GLYCERYL STEARATE, SODIUM POLYACRYLATE, POLYURETHANE-40, POTASSIUM HYDROXIDE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, DISODIUM EDTA, 1,2-HEXANEDIOL, FRAGRANCE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANEW PLATINUM DAYCREAM BROAD SPECTRUM SPF 25 
avobenzone, octinoxate, octisalate, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68577-170
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.75 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.85 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PEG-100 STEARATE (UNII: YD01N1999R)
THIAZOLYLALANINE (UNII: VTL1Y3S44B)
TRISILOXANE (UNII: 9G1ZW13R0G)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
NONENOL (UNII: 05401NS64Z)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
STEARIC ACID (UNII: 4ELV7Z65AP)
SAPINDUS RARAK FRUIT (UNII: F9J0AF4303)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
GLYCERIN (UNII: PDC6A3C0OX)
SILICA (UNII: ETJ7Z6XBU4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68577-170-00	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)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX USA, CORPORATION		010990210	manufacture(68577-170)