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

Lumene Valo Day Moisturizer SPF 15 Sunscreen Broad Spectrum SPF 15 by

Drug Labeling and Warnings

Lumene Valo Day Moisturizer SPF 15 Sunscreen Broad Spectrum SPF 15 by is a Otc medication manufactured, distributed, or labeled by Lumene Oy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67692-242
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	50 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	40 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
.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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67692-242-00	1 in 1 BOX	09/10/2016
1		50 mL in 1 JAR; Type 0: Not a Combination Product
2	NDC: 67692-242-02	1 in 1 BOX	11/22/2017
2		50 mL in 1 JAR; Type 0: Not a Combination Product
3	NDC: 67692-242-01	15 mL in 1 JAR; Type 0: Not a Combination Product	09/10/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/10/2016

Labeler - Lumene Oy (401630129)