FDA.reportPublic FDA data

Dermesse Sunscreen SPF30

Manufacturer
Axia Medical Solutions, LLC
Effective date
2021-07-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:41:26

Label at a glance#

ProductDermesse Sunscreen SPF30
Active ingredientOCTINOXATE, TITANIUM DIOXIDE
Label structure14 sections

Indications and uses

• Helps prevent sunburn

Dosage and administration

• Apply liberally 15 minutes before sun exposure • Reapply    • After 40 minutes of swimming or sweating    • Immediately after towel drying    • At least every 2 hours

Label contents#

Full prescribing information#

​Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxiate 7% w/w

Titanium Dioxide 2% w/w

​Purpose

OTC - PURPOSE SECTION

Sunscreen

​Uses:

INDICATIONS & USAGE SECTION

• Helps prevent sunburn

​Warnings:

WARNINGS SECTION

​For external use only​

Do not use on damaged or broken skin.

When using this product:

OTC - WHEN USING SECTION

• Keep out of eyes.  Rinse with water to remove.

Stop use and ask doctor if

OTC - STOP USE SECTION

• Rash or irritation develops

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• If swallowed, get medical help or contact a Poison Control Center right away.

WARNINGS SECTION

​Skin Cancer/Skin Aging Alert: ​Spending time in the sun increases your risk of skin cancer and early skin aging.  This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

​Directions

INSTRUCTIONS FOR USE SECTION

• Apply liberally 15 minutes before sun exposure

• Reapply

   • After 40 minutes of swimming or sweating

   • Immediately after towel drying

   • At least every 2 hours

OTC - ASK DOCTOR SECTION

​Children under 6 months: ​Ask a doctor

​Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Aloe Barbadensis Leaf Extract, Isocetyl Stearate, Sorbitol, Cetearyl Alcohol, Ceteareth-20, Tocopheryl Acetate, Acetyl Hexapdptide-8, Hydrolyzed Rice Protein, Alcohol SDA-40, Dimethicone, Octyl Salicylate, Cety Alcohol, Methicone, Sodium Laureth Sulfate, Carbomer, Green Tea (Carnellia Sinensis) Leaf Extract, Fragrance, Triethanolamine, Stearic Acid, Lecithin, Alumina, Caprylyl Glycol, Methylisothiazolinone

​Other information

OTHER SAFETY INFORMATION

​Protect this product from excessive heat and direct sun.

​Questions or Comments?

OTC - QUESTIONS SECTION

866-494-4466 or visit www.dermesse.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68723-330-022023-01-30C16284748780-1f386c649-b20d-0266-e053-dadaa90a7c1aDermessse Sunscreen SPF30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68723-330-02Dermesse Sunscreen SPF3057 g in 1 BOTTLELOTION574

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68723-330DERMESSE SUNSCREEN SPF30 (OCTINOXATE, TITANIUM DIOXIDE) LOTION [AXIA MEDICAL SOLUTIONS, LLC]4Legacy NDC, 1 package rows20210713_f948c01f-07c9-4c88-ac4c-cb9e504f14fd.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68723-33068723-330-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
ISOCETYL STEARATE3RJ7186O9WIACT
SORBITOL506T60A25RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ACETYL HEXAPEPTIDE-8L4EL31FWILIACT
ALCOHOL3K9958V90MIACT
DIMETHICONE 3502Y53S6ATLUIACT
OCTISALATE4X49Y0596WIACT
CETYL ALCOHOL936JST6JCNIACT
METHICONE (20 CST)6777U11MKTIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
TROLAMINE9O3K93S3TKIACT
STEARIC ACID4ELV7Z65APIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
ALUMINUM OXIDELMI26O6933IACT
CAPRYLYL GLYCOL00YIU5438UIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT

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
5adfb392-5731-496b-b352-2434161b7b9bf948c01f-07c9-4c88-ac4c-cb9e504f14fd2021-07-12WarningsExact identifier
spl id: 5adfb392-5731-496b-b352-2434161b7b9b
spl set id: f948c01f-07c9-4c88-ac4c-cb9e504f14fd

Reported adverse events (FAERS/openFDA)#

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