FDA.reportPublic FDA data

NUORI MINERAL DEFENCE SUNSCREEN WATER RESISTANT SPF 30

Manufacturer
NUORI ApS
Effective date
2022-11-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:48:34

Label at a glance#

ProductNUORI MINERAL DEFENCE SUNSCREEN WATER RESISTANT SPF 30
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

Helps prevent sunburn Higher SPF gives more sunburn protection If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

Apply liberally on clean, moisturized skin 15 minutes before sun exposure. Reapply at least every 2 hours. Reapply after 80 minutes of swimming or sweating. 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...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

INSTRUCTIONS FOR USE SECTION

  • Apply liberally on clean, moisturized skin 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Reapply after 80 minutes of swimming or sweating.
  • 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 from 10 a.m.-2 p.m.
  • Wear long-sleeved shirts, pants, hats and sunglasses.
  • Children under 6 months: ask a doctor.

Other information

OTHER SAFETY INFORMATION

  • Protect the product in this container from excessive heat and direct sun
  • You may report a serious adverse reaction to: NUORI Inc., 228 Park Ave S, Ste 300, New York, NY 10003

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua (water), caprylic/capric triglyceride, coco-caprylate/caprate, capryloyl glycerin/sebacic acid copolymer, ethyl macadamiate, ricinus communis (castor) seed oil, polyglyceryl-6 polyhydroxystearate, polyglyceryl-6 polyricinoleate, magnesium sulfate, pongamia glabra (karanja) seed oil, benzyl alcohol, hydroxyacetophenone, helianthus annuus (sunflower) seed oil, cetyl alcohol, isostearic acid, lecithin, polyglyceryl-3 polyricinoleate, polyhydroxystearic acid, hydrogenated castor oil, microcrystalline cellulose, sclerotium gum, copernicia cerifera (carnauba) wax, cellulose gum, beta-carotene, daucus carota sativa (carrot) root extract, daucus carota sativa (carrot) seed oil, tocopherol (vitamin E), malic acid, ascorbyl palmitate.

Questions?

OTC - QUESTIONS SECTION

send them to info@nuori.com

Company Information

SPL UNCLASSIFIED SECTION

MANUFACTURED IN ITALY FOR NUORI ApS

STORMGADE 35/ DK-1555 COPENHAGEN

NUORI.COM/ @NUORISKINCARE

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

nuori water resistantnuori water resistant

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72894-01472894-014-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)N7YC58165TIACT
CASTOR OILD5340Y2I9GIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
ISOSTEARIC ACIDX33R8U0062IACT
CARNAUBA WAXR12CBM0EIZIACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
ETHYL MACADAMIATEANA2NCS6V1IACT
BETA CAROTENE01YAE03M7JIACT
KARUM SEED OIL62160PU6FJIACT
SUNFLOWER OIL3W1JG795YIIACT
CARROT SEED OIL595AO13F11IACT
ZINC OXIDESOI2LOH54ZACTIB
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
WATER059QF0KO0RIACT
CARROTL56Z1JK48BIACT
ASCORBYL PALMITATEQN83US2B0NIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
BENZYL ALCOHOLLKG8494WBHIACT
TOCOPHEROLR0ZB2556P8IACT
BETASIZOFIRAN2X51AD1X3TIACT
MALIC ACID817L1N4CKPIACT
CETYL ALCOHOL936JST6JCNIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
POLYGLYCERYL-6 POLYRICINOLEATEYPM0ZOC2HRIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT

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
ed244843-0e31-1882-e053-2995a90af79fba736862-f983-3a9d-e053-2a95a90ae1512022-11-10WarningsExact identifier
spl id: ed244843-0e31-1882-e053-2995a90af79f
spl set id: ba736862-f983-3a9d-e053-2a95a90ae151

Reported adverse events (FAERS/openFDA)#

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