DERMA SOLEIL NATURAL SUNBLOCK SPF 15

Manufacturer
Biological Health Group | Derma Soleil
Effective date
2020-02-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:03:50

Label at a glance#

ProductDERMA SOLEIL NATURAL SUNBLOCK SPF 15
Active ingredientOXYBENZONE, OCTOCRYLENE, OCTISALATE, OCTINOXATE
Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Octocrylene 3%
Octyl Methoxycinnamate 6%,
Octyl Salicylate 3%,
Oxybenzone 4%

OTC - PURPOSE SECTION

Sunscreen

OTC - WHEN USING 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 SECTION

For external use only.

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

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

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

INDICATIONS & USAGE 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

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DERMA SOLEIL NATURAL SUNBLOCK SPF 15 120 mlDERMA SOLEIL NATURAL SUNBLOCK SPF 15 120 mlDERMA SOLEIL NATURAL SUNBLOCK SPF 15 240 mlDERMA SOLEIL NATURAL SUNBLOCK SPF 15 240 ml

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69711-904-012022-01-28C16284748780-1d6a99b39-6de7-a426-e053-dadaa90af4c2DERMA SOLEIL NATURAL SUNBLOCK SPF 15
69711-904-022022-01-28C16284748780-1d6a99b39-6de7-a426-e053-dadaa90af4c2DERMA SOLEIL NATURAL SUNBLOCK SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69711-904-01DERMA SOLEIL NATURAL SUNBLOCK SPF 15120 mL in 1 BOTTLELOTION1201
69711-904-02DERMA SOLEIL NATURAL SUNBLOCK SPF 15240 mL in 1 BOTTLELOTION2401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69711-904DERMA SOLEIL NATURAL SUNBLOCK SPF 15 (OCTOCRYLENE,OCTYL METHOXYCINNAMATE,OCTYL SALICYLATE,OXYBENZONE) LOTION [BIOLOGICAL HEALTH GROUP]1Legacy NDC, 2 package rows20200225_9f5770e4-7b0a-38ee-e053-2995a90a253e.zip

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69711-90469711-904-01, 69711-904-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 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
9f5770e4-7b0b-38ee-e053-2995a90a253e9f5770e4-7b0a-38ee-e053-2995a90a253e2020-02-24WarningsExact identifier
spl id: 9f5770e4-7b0b-38ee-e053-2995a90a253e
spl set id: 9f5770e4-7b0a-38ee-e053-2995a90a253e

Reported adverse events (FAERS/openFDA)#

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