FDA.reportPublic FDA data

Lumene Valo Day Moisturizer SPF 15 Sunscreen Broad Spectrum SPF 15

Manufacturer
Lumene Oy
Effective date
2021-10-22
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 22:31:08

Label at a glance#

ProductLumene Valo Day Moisturizer SPF 15 Sunscreen Broad Spectrum SPF 15
Active ingredientOCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE
Label structure7 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

Apply liberally 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating Reapply at least every 2 hours Children under 6 months of age: ask a doctor 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...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%

Oxybenzone 5.0%

Octisalate 4.0%

Avobenzone 3.0%

PURPOSE

OTC - PURPOSE SECTION

Sunscreen

USES

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.

WARNINGS

WARNINGS SECTION

For external use only.

Do not use

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 poison control center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • Children under 6 months of age: ask a doctor
  • 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 form 10 a.m. -2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sun

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

AQUA (WATER), HEPTYL UNDECYLENATE, CETEARYL ALCOHOL, HYDROGENATED POLYISOBUTENE, PROPANEDIOL, GLYCERIN, SQUALANE, PHENOXYETHANOL, BUTYLENE GLYCOL, CETEARYL GLUCOSIDE, TOCOPHERYL ACETATE, GLYCERYL STEARATE, PEG-100 STEARATE, PANTHENOL, POLYACRYLAMIDE, XANTHAN GUM, ACRYLATES/C1O-30 ALKYL ACRYLATE CROSSPOLYMER, LECITHIN, C13-14 ISOPARAFFIN, (CI 77891) TITANIUM DIOXIDE, DISODIUM EDTA, ETHYLHEXYLGLYCERIN, MAGNESIUM ASCORBYL PHOSPHATE, MICA, HIPPOPHAE RHAMNOIDES (SEA BUCKTHORN) OIL, RUBUS CHAMAEMORUS (CLOUDBERRY) SEED OIL, PEG-8, CAPRYLYL GLYCOL, SODIUM HYDROXIDE, LAURETH-7, TOCOPHEROL, LACTIC ACID, SERINE, SODIUM LACTATE, SORBITOL TEA-LACTATE, UREA, RUBUS CHAMAEMORUS (CLOUDBERRY) SEED EXTRACT, ASCORBYL PALMITATE, SODIUM CHLORIDE, CHONDRUS CRISPUS (CARRAGEENAN), ASCORBIC ACID, CITRIC ACID, ALLANTOIN, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, LIMONENE, LINALOOL, BUTYLPHENYL METHYLPROPIONAL, GERANIOL, CITRAL, HEXYL CINNAMAL, CITRONELLOL, PARFUM(FRAGRANCE)

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

General LabelGeneral LabelPackage label DetailsPackage label DetailsInactive IngredientsInactive Ingredients

Products#

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

DailyMed product names page 1 of 2 · 49 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67692-24267692-242-00, 67692-242-02, 67692-242-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 47 matching rows.

Name, UNII, Kind table
NameUNIIKind
.ALPHA.-HEXYLCINNAMALDEHYDE7X6O37OK2IIACT
WATER059QF0KO0RIACT
HEPTYL UNDECYLENATEW77QUB6GXOIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
HYDROGENATED POLYBUTENE (1300 MW)7D1YQ9Y5EZIACT
PROPANEDIOL5965N8W85TIACT
GLYCERINPDC6A3C0OXIACT
SQUALANEGW89575KF9IACT
PHENOXYETHANOLHIE492ZZ3TIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
PANTHENOLWV9CM0O67ZIACT
XANTHAN GUMTTV12P4NEEIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
MAGNESIUM ASCORBYL PHOSPHATE0R822556M5IACT
MICAV8A1AW0880IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SODIUM HYDROXIDE55X04QC32IIACT
LAURETH-7Z95S6G8201IACT
TOCOPHEROLR0ZB2556P8IACT
LACTIC ACID33X04XA5ATIACT
SERINE452VLY9402IACT
SODIUM LACTATETU7HW0W0QTIACT
ASCORBYL PALMITATEQN83US2B0NIACT
SODIUM CHLORIDE451W47IQ8XIACT
CHONDRUS CRISPUS CARRAGEENANUE856F2T78IACT
ASCORBIC ACIDPQ6CK8PD0RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ALLANTOIN344S277G0ZIACT
SUNFLOWER OIL3W1JG795YIIACT
ROSEMARYIJ67X351P9IACT
LIMONENE, (+)-GFD7C86Q1WIACT
LINALOOL, (+/-)-D81QY6I88EIACT

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
06f1d8cd-3373-1426-e063-6394a90a3969d1b90cd4-5059-41ca-b24e-15dcb073c9e32023-10-05WarningsExact identifier
spl set id: d1b90cd4-5059-41ca-b24e-15dcb073c9e3

Reported adverse events (FAERS/openFDA)#

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