FDA.reportPublic FDA data

LUMENE CC COLOR CORRECTING CREAM SUNSCREEN BROAD SPECTRUM SPF 20 LIGHT

Manufacturer
Lumene Oy
Effective date
2017-12-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:05:41

Label at a glance#

ProductLUMENE CC COLOR CORRECTING SUNSCREEN BROAD SPECTRUM SPF 20 LIGHT
Active ingredientOCTINOXATE, TITANIUM DIOXIDE
Label structure7 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating 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, especiall...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 4.0%

Titanium dioxide 0.8%

Purpose

OTC - PURPOSE SECTION

sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.

Warnings

WARNINGS SECTION

For external use only.

Do not ues

OTC - DO NOT USE SECTION

on damaged or broken skin.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs.

When using this product,

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • 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

Inacitve ingredients

INACTIVE INGREDIENT SECTION

WATER, CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, ISODODECANE, DIMETHICONE, POLYGLYCERYL-4 ISOSTEARATE, MAGNESIUM SULFATE, CETYL PEG/PPF-10/1 DIMETHICONE, HEXYL LAURATE, MICA, NYLON-12, PROPYLENE GLYCOL, LINGONBERRY (VACCINIUM VITIS-IDAEA) SEED OIL, CLOUDBERRY (RUBUS CHAMAEMORUS) SEED EXTRACT, CETEARYL DIMETHICONE CROSSPOLYMER, PHENOXYETHANOL, DISTEARDIMONIUM HECTORITE, PERFLUOROOCTYL TRIETHOXYSILANE, ALUMINUM HYDROXIDE, PROPANEDIOL, PROPYLENE CARBONATE, METHICONE, ETHYLHEXYLGLYCERIN, GLYCERIN, ALUMINA, TRIETHOXYCAPRYLYLSILANE, SUNFLOWER (HELIANTHUS ANNUUS) SEED OIL, ROSEMARY (ROSMARINUS OFFICINALIS) LEAF EXTRACT, FRAGRANCE, TITANIUM DIOXIDE, IRON OXIDES

Other information

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sun.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-135011046008160GTIN-13: 5011046008160
EAN-13: 5011046008160
GTIN storage (14 digits): 05011046008160		Label2.jpg

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
67692-82167692-821-00

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
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
CYCLOMETHICONE 6XHK3U310BAIACT
ISODODECANEA8289P68Y2IACT
DIMETHICONE92RU3N3Y1OIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
HEXYL LAURATE4CG9F9W01QIACT
MICAV8A1AW0880IACT
NYLON-12446U8J075BIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
LINGONBERRY SEED OIL44P1VFO6KMIACT
RUBUS CHAMAEMORUS WHOLEO90MY5Z91VIACT
PHENOXYETHANOLHIE492ZZ3TIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
PROPANEDIOL5965N8W85TIACT
PROPYLENE CARBONATE8D08K3S51EIACT
METHICONE (20 CST)6777U11MKTIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
ALUMINUM OXIDELMI26O6933IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
SUNFLOWER OIL3W1JG795YIIACT
ROSEMARYIJ67X351P9IACT
FERRIC OXIDE RED1K09F3G675IACT
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB

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
cef78587-a503-6797-e053-2995a90ac19f4bdfbc68-ed10-473f-e054-00144ff8d46c2021-10-22WarningsExact identifier
spl set id: 4bdfbc68-ed10-473f-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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