Deux Derme - Age and Dark Spot Prevention

Manufacturer
Cosmetic Solutions LLC
Effective date
2019-09-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:00:36

Label at a glance#

ProductDeux Derme - Age and Dark Spot Prevention
Active ingredientOCTINOXATE, TITANIUM DIOXIDE
Label structure9 sections

Indications and uses

Help prevent sunburn.

Dosage and administration

Apply to all skin exposed to the sun. *Apply liberally and evenly 15 minutes before sun exposure. *Reapply after 40 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours. *For children under 6 months of age: Ask a doctor. 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 v...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 2.5%, Octinoxate 7%.

Purpose

OTC - PURPOSE SECTION

Sunscreen

USES

INDICATIONS & USAGE SECTION

Help prevent sunburn.

WARNINGS

WARNINGS SECTION

OTC - DO NOT USE SECTION

For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. 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

Apply to all skin exposed to the sun. *Apply liberally and evenly 15 minutes before sun exposure. *Reapply after 40 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours. *For children under 6 months of age: Ask a doctor.

Sun Protection Measures

SPL UNCLASSIFIED SECTION

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.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

OTHER INFORMATION

STORAGE AND HANDLING SECTION

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

PRINCIPAL DISPLAY PANEL - 60 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DEUX + DERMÈ

AGE & DARK SPOT
PREVENTION

SpotActive-xl™ and SPF30 Broad Spectrum
Sunscreen

Daily Advanced Cream Concentrate Formula
for Age & Dark Spots

A scientific formula to protect against both
UVA and UVB radiation and reduce the
appearance of age spots

CRUELTY-FREE & VEGAN

2.0 fl.oz / 60ml

Principal Display Panel - 60 ml Bottle Label
Principal Display Panel - 60 ml Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66163-6503-22021-01-29C16284748780-1ba0f9c33-280f-a910-e053-dadaa90a0b85Deux Derme - Age & Dark Spot Prevention

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66163-6503-2Deux Derme - Age and Dark Spot Prevention60 mL in 1 BOTTLE, PLASTICLOTION601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66163-6503DEUX DERME - AGE AND DARK SPOT PREVENTION (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [COSMETIC SOLUTIONS LLC]1Legacy NDC, 1 package rows20190928_6b98cc3f-8f8f-4a5a-a12b-958602d45590.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
66163-650366163-6503-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 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
6d1f30e0-175e-4f2d-9171-b2d18bd121656b98cc3f-8f8f-4a5a-a12b-958602d455902019-09-27WarningsExact identifier
spl id: 6d1f30e0-175e-4f2d-9171-b2d18bd12165
spl set id: 6b98cc3f-8f8f-4a5a-a12b-958602d45590

Reported adverse events (FAERS/openFDA)#

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