FDA.reportPublic FDA data

Derma Soleil Natural Sunblock SPF 45

Manufacturer
Derma Soleil
Effective date
2017-07-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:52:03

Label at a glance#

ProductDerma Soleil Natural Sunblock SPF 45
Active ingredientOCTINOXATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE
Label structure9 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 skin 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit t...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

  • Octocrylene 7%
  • Octyl Methoxycinnamate 7.5%,
  • Octyl Salicylate 5%,
  • Oxybenzone 6%

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 skin aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs.

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION 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 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 • children under 6 months of age: ask a doctor

Ingredients

INACTIVE INGREDIENT SECTION

Aloe Vera Gel, C12-15 Alkyl Benzoate, Aqua and Glycerin and Sodium Levulinate and Sodium Anisate, Fragrance, Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Aminomethyl Propanol, Carbomer, Titanium Dioxide, Hydroxypropyl Methylcellulose, Tetrasodium EDTA, Evening Primrose Oil, Avocado Oil, Jojoba Oil, Grape Seed Oil, Blue Chamomile Oil, Calendula Oil, Hydrolyzed Wheat Protein, Retinyl Palmitate, Ascorbic Acid, Tocopherol Acetate.

PRINCIPAL DISPLAY PANEL - 120 ml Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Derma Soleil

Natural Sunblock SPF 45
80% Natural

Moisturizing with Vitamins A, C, E & Aloe

UVA+UVB Protection
Water Resistant (40 minutes)
PABA Free

For All Skin Types

Broad Spectrum
SPF 45+

Net 4 fl. Oz (120 ml)

12 ml Tube12 ml Tube

PRINCIPAL DISPLAY PANEL - 240 ml Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Derma Soleil Health

Natural Sunblock SPF 45
80% Natural

Moisturizing with Vitamins A, C, E & Aloe

UVA+UVB Protection
Water Resistant (40 minutes)
PABA Free

For All Skin Types

Broad Spectrum
SPF 45+

Net 8 fl. Oz (240 ml)

240 ml Tube240 ml Tube

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130827118730137GTIN-13: 0827118730137
EAN-13: 0827118730137
GTIN-12: 827118730137
UPC-A: 827118730137
GTIN storage (14 digits): 00827118730137		69711-456-DS Adult SPF45 240mL Label.jpg
BarcodeEAN-130827118730229GTIN-13: 0827118730229
EAN-13: 0827118730229
GTIN-12: 827118730229
UPC-A: 827118730229
GTIN storage (14 digits): 00827118730229		69711-456-DS Adult SPF45 120mL Label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69711-458-012020-01-31C16284748780-19d75b9d0-e30e-f424-e053-dadaa90a57ceDerma Soleil Natural Sunblock SPF 45
69711-458-022020-01-31C16284748780-19d75b9d0-e30e-f424-e053-dadaa90a57ceDerma Soleil Natural Sunblock SPF 45

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69711-458-01Derma Soleil Natural Sunblock SPF 45120 mL in 1 TUBELOTION1201
69711-458-02Derma Soleil Natural Sunblock SPF 45240 mL in 1 TUBELOTION2401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69711-458DERMA SOLEIL NATURAL SUNBLOCK SPF 45 (OCTOCRYLENE, OCTYL METHOXYCINNAMATE, OCTYL SALICYLATE, OXYBENZONE) LOTION [DERMA SOLEIL]1Legacy NDC, 2 package rows20170724_55140bff-58de-3ae2-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69711-45869711-458-01, 69711-458-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OXYBENZONE95OOS7VE0YACTIB
GLYCERINPDC6A3C0OXIACT
EDETATE SODIUMMP1J8420LUIACT
EVENING PRIMROSE OIL3Q9L08K71NIACT
JOJOBA OIL724GKU717MIACT
GRAPE SEED OIL930MLC8XGGIACT
CHAMOMILE FLOWER OIL60F80Z61A9IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
OCTOCRYLENE5A68WGF6WMACTIB
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
AVOCADO OIL6VNO72PFC1IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
WATER059QF0KO0RIACT
SODIUM LEVULINATEVK44E1MQU8IACT
SODIUM ANISATEF9WFJ28MV9IACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
HYPROMELLOSES3NXW29V3WOIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW)J2S07SB0YLIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
ALOE VERA LEAFZY81Z83H0XIACT

Source Document#

Source XML · Source PDF

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
55140bff-58df-3ae2-e054-00144ff88e8855140bff-58de-3ae2-e054-00144ff88e882017-07-24WarningsExact identifier
spl id: 55140bff-58df-3ae2-e054-00144ff88e88
spl set id: 55140bff-58de-3ae2-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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