FDA.reportPublic FDA data

ZINC OXIDE

Manufacturer
Lumene Oy
Effective date
2021-03-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:48:14

Label at a glance#

ProductLumene Valo Nordic-C Brightening Day Fluid Mineral Sunscreen Broad Spectrum SPF 30
Active ingredientZINC OXIDE
Label structure7 sections

Indications and 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

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 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, especi...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

zinc Oxide 15.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs

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
  • 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

SPL UNCLASSIFIED SECTION

  • Protect this product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

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:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67692-57767692-577-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DICAPRYLYL ETHER77JZM5516ZIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
GLYCERINPDC6A3C0OXIACT
POLYGLYCERYL-4 OLEATE15B05TY4GXIACT
ETHYL OLEATEZ2Z439864YIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
DIMETHICONE92RU3N3Y1OIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
RUBUS CHAMAEMORUS WHOLEO90MY5Z91VIACT
ALMOND OIL66YXD4DKO9IACT
MAGNESIUM STEARATE70097M6I30IACT
PHENOXYETHANOLHIE492ZZ3TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
XYLITYLGLUCOSIDEO0IEZ166FBIACT
ASCORBYL TETRAISOPALMITATE47143LT58AIACT
PROPANEDIOL5965N8W85TIACT
ANHYDROXYLITOL8XWR7NN42FIACT
NEOPENTYL GLYCOL DIETHYLHEXANOATEU68ZV6W62CIACT
TOCOPHEROLR0ZB2556P8IACT
SODIUM GLUCONATER6Q3791S76IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDEYK3DC63Y5MIACT
PALMITIC ACID2V16EO95H1IACT
STANNIC OXIDEKM7N50LOS6IACT
SODIUM HYDROXIDE55X04QC32IIACT
SALVIA ROSMARINUS FLOWERING TOP8JM482TI79IACT
FERRIC OXIDE RED1K09F3G675IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ZINC OXIDESOI2LOH54ZACTIM

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
06f1fef9-073f-f988-e063-6394a90ae2baf6991d2b-ac2b-4999-8f46-2b042f54779d2023-10-05WarningsExact identifier
spl set id: f6991d2b-ac2b-4999-8f46-2b042f54779d

Reported adverse events (FAERS/openFDA)#

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