VERSED DAILY SUNSCREEN SPF 50- homosalate, octisalate, avobenzone cream

VERSED DAILY SUNSCREEN SPF 50 by

Drug Labeling and Warnings

VERSED DAILY SUNSCREEN SPF 50 by is a Otc medication manufactured, distributed, or labeled by COSMAX USA, CORP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Avobenzone 3%

Homosalate 7.3%

Octisalate 5%

PURPOSE

Purpose

Sunscreen

USES

Use

• helps prevent sunburn

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 product is swallowed, get medical help or contact a Poison Control center right away.

DIRECTIONS

Directions

• Apply generously and evenly 15 minutes before sun exposure.
• 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 10am-2pm
• Wear long-sleeved shirts, pants, hats, and sunglasses.
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating.

OTHER INFORMATION

Other information

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

INACTIVE INGREDIENT

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Ethylhexyl Methoxycrylene, Dipropylene Glycol, Betaine, Shorea Stenoptera Seed Butter, VP/Hexadecene Copolymer, Ceramide NP, Arginine, Serine, Alanine, Glycine, Threonine, Proline, Valine, Histidine, Isoleucine, Phenylalanine, Aspartic Acid, Spirodela Polyrhiza Extract, PCA, Sodium PCA, Bisabolol, Hydroxyacetophenone, Dibutyl Lauroyl Glutamide, Dibutyl Ethylhexanoyl Glutamide, Glycolipids, Dipotassium Glycyrrhizate, Sodium Lactate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Carbomer, Pentylene Glycol, Tromethamine, Phenoxyethanol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VERSED DAILY SUNSCREEN SPF 50 
homosalate, octisalate, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68577-203
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mg  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7.3 mg  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
THREONINE (UNII: 2ZD004190S)
PHENYLALANINE (UNII: 47E5O17Y3R)
SHOREA STENOPTERA SEED BUTTER (UNII: 129R0X862G)
SODIUM PCA (UNII: 469OTG57A2)
TROMETHAMINE (UNII: 023C2WHX2V)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
VP/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
GLYCINE (UNII: TE7660XO1C)
VALINE (UNII: HG18B9YRS7)
HISTIDINE (UNII: 4QD397987E)
ALANINE (UNII: OF5P57N2ZX)
SERINE (UNII: 452VLY9402)
BISABOLOL (UNII: 24WE03BX2T)
DIBUTYL ETHYLHEXANOYL GLUTAMIDE (UNII: 0IAF2L30VS)
DIBUTYL LAUROYL GLUTAMIDE (UNII: 3V7K3IA58X)
CARBOMER (UNII: 0A5MM307FC)
DIPOTASSIUM GLYCYRRHIZATE (UNII: CA2Y0FE3FX)
SODIUM LACTATE (UNII: TU7HW0W0QT)
ARGININE (UNII: 94ZLA3W45F)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
SPIRODELA POLYRHIZA (UNII: BJS9J628MG)
ISOLEUCINE (UNII: 04Y7590D77)
PROLINE (UNII: 9DLQ4CIU6V)
WATER (UNII: 059QF0KO0R)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
BETAINE (UNII: 3SCV180C9W)
CERAMIDE NP (UNII: 4370DF050B)
ASPARTIC ACID (UNII: 30KYC7MIAI)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
PCA (UNII: SZB83O1W42)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68577-203-01	1 in 1 CARTON	10/01/2025
1		1.7 mL in 1 TUBE; 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	10/01/2025

Labeler - COSMAX USA, CORP (010990210)

Registrant - COSMAX USA, CORP (010990210)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX USA, CORP		010990210	manufacture(68577-203)