FDA.reportPublic FDA data

VERSED DAILY SUNSCREEN SPF 50

Manufacturer
COSMAX USA, CORP
Effective date
2025-12-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:28:06

Label at a glance#

ProductVERSED DAILY SUNSCREEN SPF 50
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE
Label structure8 sections

Indications and uses

Use helps prevent sunburn

Dosage and administration

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 sungla...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Avobenzone 3%

Homosalate 7.3%

Octisalate 5%

OTC - PURPOSE SECTION

Purpose

Sunscreen

USES

INDICATIONS & USAGE SECTION

Use

  • helps prevent sunburn

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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 SAFETY INFORMATION

Other information

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68577-203-01VERSED DAILY SUNSCREEN SPF 501 in 1 CARTONCREAM11
68577-203-01VERSED DAILY SUNSCREEN SPF 501.7 mL in 1 TUBECREAM1.71

Products#

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

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68577-20368577-203-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Name, UNII, Kind table
NameUNIIKind
THREONINE2ZD004190SIACT
PHENYLALANINE47E5O17Y3RIACT
SHOREA STENOPTERA SEED BUTTER129R0X862GIACT
SODIUM PCA469OTG57A2IACT
TROMETHAMINE023C2WHX2VIACT
PENTYLENE GLYCOL50C1307PZGIACT
VP/HEXADECENE COPOLYMERKFR5QEN0N9IACT
GLYCINETE7660XO1CIACT
VALINEHG18B9YRS7IACT
HISTIDINE4QD397987EIACT
ALANINEOF5P57N2ZXIACT
SERINE452VLY9402IACT
BISABOLOL24WE03BX2TIACT
DIBUTYL ETHYLHEXANOYL GLUTAMIDE0IAF2L30VSIACT
DIBUTYL LAUROYL GLUTAMIDE3V7K3IA58XIACT
CARBOMER0A5MM307FCIACT
DIPOTASSIUM GLYCYRRHIZATECA2Y0FE3FXIACT
SODIUM LACTATETU7HW0W0QTIACT
ARGININE94ZLA3W45FIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
SPIRODELA POLYRHIZABJS9J628MGIACT
ISOLEUCINE04Y7590D77IACT
PROLINE9DLQ4CIU6VIACT
WATER059QF0KO0RIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
HYDROXYACETOPHENONEG1L3HT4CMHIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
BETAINE3SCV180C9WIACT
CERAMIDE NP4370DF050BIACT
ASPARTIC ACID30KYC7MIAIIACT
OCTISALATE4X49Y0596WACTIB
DIPROPYLENE GLYCOLE107L85C40IACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
PCASZB83O1W42IACT

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
57c45da1-74f1-1805-e063-6394a90a1511468dd98e-9578-955b-e063-6294a90ada532026-07-29WarningsExact identifier
spl set id: 468dd98e-9578-955b-e063-6294a90ada53

Reported adverse events (FAERS/openFDA)#

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