LUMENE VALO NORDIC-C BRIGHTENING DAY FLUID MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- zinc oxide cream

Lumene Valo Nordic-C Brightening Day Fluid Mineral Sunscreen Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Lumene Valo Nordic-C Brightening Day Fluid Mineral Sunscreen Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Lumene Oy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

zinc Oxide 15.5%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see D irections), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

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

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
• Reapply at least every 2 hours. 
• Use a water resistant sunscreen if swimming or sweating
• Sun Protections Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regurlarly 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

Other information

• Protect this product from excessive heat and direct sun

Inactive ingredients

WATER, DICAPRYLYL ETHER, CAPRYLIC/CAPRIC TRIGLYCERIDE, DICAPRYLYL CARBONATE, POLYHYDROXYSTEARIC ACID, GLYCERIN, POLYGLYCERYL-4 OLEATE, ETHYL OLEATE, SILICA, DIMETHICONE, POLYGLYCERYL-6 OLEATE, MAGNESIUM SULFATE, CLOUDBERRY (RUBUS CHAMAEMORUS) FRUIT JUICE EXTRACT, SWEET ALMOND (PRUNUS AMYGDALUS DULCIS) OIL, CLOUDBERRY (RUBUS CHAMAEMORUS) SEED EXTRACT, MAGNESIUM STEARATE, PHENOXYETHANOL, TOCOPHEROL ACETATE, XYLITYLGLUCOSIDE, ASCORBYL TETRAISOPALMITATE, CETEARYL DIMETHICONE CROSSPOLYMER, PROPANEDIOL, ANHYDROXYLITOL, NEOPENTYL GLYCOL DIETHYLHEXANOATE, TOCOPHEROL, HYDROGENATED VEGETABLE OIL, SODIUM GLUCONATE, ETHYLHEXYLGLYCERIN, SYNTHETIC FLUROPHLOGOPITE, HYDROLYZED HYALURONIC ACID, PALMITIC ACID, TIN OXIDE, SODIUM HYDROXIDE, ROSEMARY (ROSMARINUS OFFICINALIS) LEAF EXTRACT, FRAGRANCE, IRON OXIDES, TITANIUM DIOXIDE      A1020

Package Labeling:

INGREDIENTS AND APPEARANCE

LUMENE VALO NORDIC-C BRIGHTENING DAY FLUID MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67692-577
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	155 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-4 OLEATE (UNII: 15B05TY4GX)
ETHYL OLEATE (UNII: Z2Z439864Y)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
RUBUS CHAMAEMORUS WHOLE (UNII: O90MY5Z91V)
ALMOND OIL (UNII: 66YXD4DKO9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)
PROPANEDIOL (UNII: 5965N8W85T)
ANHYDROXYLITOL (UNII: 8XWR7NN42F)
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM GLUCONATE (UNII: R6Q3791S76)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
PALMITIC ACID (UNII: 2V16EO95H1)
STANNIC OXIDE (UNII: KM7N50LOS6)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SALVIA ROSMARINUS FLOWERING TOP (UNII: 8JM482TI79)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67692-577-00	1 in 1 BOX	04/01/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/01/2021

Labeler - Lumene Oy (401630129)

Establishment
Name	Address	ID/FEI	Business Operations
Lumene Oy		401630129	manufacture(67692-577)