Dermesse Sunscreen SPF30 Medium Tint

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 Medium Tint
Active ingredientOCTINOXATE, ZINC OXIDE
Label structure13 sections

Indications and uses

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

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 • 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 broad spectrum SPF of 15 or higher and other sun protection measures including:    ...

Label contents#

Full prescribing information#

​Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxiate 7.5% w/w

Zinc Oxide 7% w/w

​Purpose

OTC - PURPOSE SECTION

Sunscreen

​Uses:

INDICATIONS & USAGE SECTION

• Helps prevent sunburn

• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early aging caused by the sun.

​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.

​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

• 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 broad spectrum SPF 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 sleeve shirts, pants, hats, and sunglasses

OTC - ASK DOCTOR SECTION

​Children under 6 months: ​Ask a doctor

​Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Cyclomethicone, C12-15 Alkyl Benzoate, C18-38 Alkyl Hydroxystearoyl Stearate, Hexylene Glycol, Aloe Barbadensis Leaf Extract, PEG-40 Stearate, Glycerin, Aluminum Starch Octenylsuccinate, Carnauba Wax, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, PEG100 Stearate, Squalane, Tocopheryl Acetate, Propylene Glycol, Siliconyl Beeswax, Stearoxytrimethylsilane, Green Tea (Camellia Sinensis) Leaf Extract, Glyceryl Dilaurate, Dimethicone, Glyceryl Stearate, Cetearyl Alcohol, Stearyl Alcohol, Steareth-100, Titanium Dioxide, Sorbitan Tristearate, Ceteareth-20, VP/Eicosene Copolymer, Polysorbate-60, Beheneth-5, Triethoxycaprylylsilane, Caprylyl Glycol, Fragrance, Methylisothiazolinone, Iron Oxides: Yellow (C177492), Red (C177491), Black (C177499)

​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
68723-331-022023-01-30C16284748780-1f386c64a-1451-0266-e053-dadaa90a7c1aDermessse Sunscreen SPF30 Tint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68723-331-02Dermesse Sunscreen SPF30 Medium Tint57 g in 1 BOTTLELOTION574

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68723-331DERMESSE SUNSCREEN SPF30 MEDIUM TINT (OCTINOXATE, ZINC OXIDE) LOTION [AXIA MEDICAL SOLUTIONS, LLC]4Legacy NDC, 1 package rows20210713_d22f1a00-121a-4d25-b956-21540e8908aa.zip

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
68723-33168723-331-02

Ingredients#

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

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

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
4b4fda56-047d-4a29-a538-3a5a91c071aad22f1a00-121a-4d25-b956-21540e8908aa2021-07-12WarningsExact identifier
spl id: 4b4fda56-047d-4a29-a538-3a5a91c071aa
spl set id: d22f1a00-121a-4d25-b956-21540e8908aa

Reported adverse events (FAERS/openFDA)#

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