FDA.reportPublic FDA data

ISA KNOX UV SUN PRO 365 Sheer Mineral Face

Manufacturer
LG HOUSEHOLD & HEALTH CARE LTD.
Effective date
2025-04-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:00:44

Label at a glance#

ProductISA KNOX UV SUN PRO 365 Sheer Mineral Face
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measure (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

For sunscreen use: apply liberally 15 minutes before sun exposure children under 6 months of age: ask a doctor reapply after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours 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...

Storage and handling

protect the product in this container from excessive heat and direct sun the proudct may stain certain types of fabrics

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 15.52%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measure (see Directions), 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

Do not use on damaged or broken skin

When using

OTC - WHEN USING SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Stop use

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

DOSAGE & ADMINISTRATION SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

INSTRUCTIONS FOR USE SECTION

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • children under 6 months of age: ask a doctor
  • reapply
    • after 40 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours

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

Other information

STORAGE AND HANDLING SECTION

  • protect the product in this container from excessive heat and direct sun
  • the proudct may stain certain types of fabrics

Inactive Ingredients

INACTIVE INGREDIENT SECTION

WATER, DIMETHICONE, BENZOTRIAZOLYL DODECYL P-CRESOL, CYCLOPENTASILOXANE, POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, DIPROPYLENE GLYCOL, GLYCERIN, DISTEARDIMONIUM HECTORITE, 1,2-HEXANEDIOL, ISOSTEARIC ACID, MAGNESIUM SULFATE, PANTHENOL, POLYGLYCERYL-6 POLYRICINOLEATE, DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER, NIACINAMIDE, CAPRYLIC/CAPRIC TRIGLYCERIDE, TRIETHOXYCAPRYLYLSILANE, DISTEARYLDIMONIUM CHLORIDE, CITRUS AURANTIFOLIA (LIME) OIL, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL, PELARGONIUM GRAVEOLENS FLOWER OIL, AMYRIS BALSAMIFERA BARK OIL, MYRISTICA FRAGRANS (NUTMEG) EXTRACT, RICINUS COMMUNIS (CASTOR) SEED OIL, CANANGA ODORATA FLOWER OIL, SANTALUM ALBUM (SANDALWOOD) OIL, JUNIPERUS VIRGINIANA OIL, BOSWELLIA CARTERII OIL, SODIUM CITRATE, TOCOPHEROL, PAEONOL, PAEONIA SUFFRUTICOSA BRANCH/FLOWER/LEAF EXTRACT, LIMONENE, LINALOOL, CITRONELLOL, GERANIOL, CITRAL

Questions?

OTC - QUESTIONS SECTION

1-866-993-4709

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BOTTLEBOTTLE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CARTONCARTON

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53208-003-01ISA KNOX UV SUN PRO 365 Sheer Mineral Face50 mL in 1 BOTTLECREAM502
53208-003-02ISA KNOX UV SUN PRO 365 Sheer Mineral Face1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53208-003ISA KNOX UV SUN PRO 365 SHEER MINERAL FACE (ZINC OXIDE) CREAM [LG HOUSEHOLD & HEALTH CARE LTD.]2Current NDC, 2 package rows20250511_2eeac795-b74e-b3a3-e063-6294a90abf52.zip

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53208-00353208-003-01, 53208-003-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRONELLOLP01OUT964KIACT
BENZOTRIAZOLYL DODECYL P-CRESOL298PX4M11XIACT
GLYCERINPDC6A3C0OXIACT
NIACINAMIDE25X51I8RD4IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL39W1PKE3JIIACT
POLYGLYCERYL-6 POLYRICINOLEATEYPM0ZOC2HRIACT
AMYRIS BALSAMIFERA OILI1BJ961J2EIACT
WATER059QF0KO0RIACT
CYCLOPENTASILOXANE0THT5PCI0RIACT
DIPROPYLENE GLYCOLE107L85C40IACT
SANTALUM ALBUM (SANDALWOOD) OILX7X01WMQ5FIACT
NUTMEGAEE24M3MQ9IACT
DIMETHICONE92RU3N3Y1OIACT
SODIUM CITRATE1Q73Q2JULRIACT
PELARGONIUM GRAVEOLENS FLOWER OIL3K0J1S7QGCIACT
CANANGA ODORATA FLOWER OIL8YOY78GNNXIACT
BOSWELLIA CARTERII OIL67ZYA5T02KIACT
TOCOPHEROLR0ZB2556P8IACT
LIMONENE, (+)-GFD7C86Q1WIACT
LINALOOLD81QY6I88EIACT
CITRALT7EU0O9VPPIACT
DISTEARYLDIMONIUM CHLORIDEOM9573ZX3XIACT
ISOSTEARIC ACIDX33R8U0062IACT
DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER2P2G24V6T9IACT
RICINUS COMMUNIS (CASTOR) SEED OILD5340Y2I9GIACT
JUNIPERUS VIRGINIANA OILPAD4FN7P2GIACT
PAEONOL3R834EPI82IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
PANTHENOLWV9CM0O67ZIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
MAGNESIUM SULFATEDE08037SABIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
CITRUS AURANTIFOLIA (LIME) OILUZH29XGA8GIACT
GERANIOLL837108USYIACT
ZINC OXIDESOI2LOH54ZACTIB

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
ISA KNOX UV SUN PRO 365 Sheer Mineral FaceZINC OXIDELG HOUSEHOLD & HEALTH CARE LTD.2eeac795-b74e-b3a3-e063-6294a90abf522025-04-08WarningsExact identifier
ndc (package): 53208-003-02
ndc (package): 53208-003-01
ndc (product): 53208-003
ndc11 (package): 53208000301
ndc11 (package): 53208000302
spl id: 32457b13-65e4-94bb-e063-6394a90a955e
spl set id: 2eeac795-b74e-b3a3-e063-6294a90abf52

Reported adverse events (FAERS/openFDA)#

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