LUMENE VALO DAY MOISTURIZER SPF 15 SUNSCREEN BROAD SPECTRUM SPF 15- octinoxate, oxybenzone, octisalate, avobenzone cream 
Lumene Oy

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Lumene Valo Day Moisturizer SPF 15 Sunscreen Broad Spectrum SPF 15

Drug Facts

ACTIVE INGREDIENTS

Octinoxate 7.5%

Oxybenzone 5.0%

Octisalate 4.0%

Avobenzone 3.0%

PURPOSE

Sunscreen

USES

  • Helps prevent sunburn.

WARNINGS

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.

DIRECTIONS

  • 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

Protect this product from excessive heat and direct sun

INACTIVE INGREDIENTS:

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:

General LabelPackage label DetailsInactive Ingredients

LUMENE VALO DAY MOISTURIZER SPF 15 SUNSCREEN BROAD SPECTRUM SPF 15 
octinoxate, oxybenzone, octisalate, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67692-242
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE40 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
WATER (UNII: 059QF0KO0R)  
HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
PROPANEDIOL (UNII: 5965N8W85T)  
GLYCERIN (UNII: PDC6A3C0OX)  
SQUALANE (UNII: GW89575KF9)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PANTHENOL (UNII: WV9CM0O67Z)  
XANTHAN GUM (UNII: TTV12P4NEE)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
MICA (UNII: V8A1AW0880)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
LAURETH-7 (UNII: Z95S6G8201)  
TOCOPHEROL (UNII: R0ZB2556P8)  
LACTIC ACID (UNII: 33X04XA5AT)  
SERINE (UNII: 452VLY9402)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ALLANTOIN (UNII: 344S277G0Z)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
ROSEMARY (UNII: IJ67X351P9)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
GERANIOL (UNII: L837108USY)  
CITRAL (UNII: T7EU0O9VPP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67692-242-001 in 1 BOX09/10/201603/10/2023
150 mL in 1 JAR; Type 0: Not a Combination Product
2NDC:67692-242-021 in 1 BOX11/22/201704/19/2020
250 mL in 1 JAR; Type 0: Not a Combination Product
3NDC:67692-242-0115 mL in 1 JAR; Type 0: Not a Combination Product09/10/201609/21/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02009/10/201603/10/2023
Labeler - Lumene Oy (401630129)

Revised: 10/2023
Document Id: 06f1d8cd-3373-1426-e063-6394a90a3969
Set id: d1b90cd4-5059-41ca-b24e-15dcb073c9e3
Version: 7
Effective Time: 20231005
 
Lumene Oy