FDA.reportPublic FDA data

innisfree Gentle Care for Sensitive Skin Sunscreen

Manufacturer
Innisfree Corporation
Effective date
2021-04-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:47:23

Label at a glance#

Productinnisfree Gentle Care for Sensitive Skin Sunscreen
Active ingredientTITANIUM DIOXIDE
Label structure10 sections

Indications and uses

Helps prevent sunburn 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 15 minutes before sun exposure Reapply at least every 2 hours. Use a water-resistant sunscreen if 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, especial...

Storage and handling

Protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 4.46%

PURPOSE

OTC - PURPOSE SECTION

Sunscreen

USES

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • 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 reach of children. If swallowed, call a poison control centre or get medical help 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 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 of age : Ask a doctor.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • Protect the product in this container from excessive heat and direct sun

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER / AQUA / EAU, PROPANEDIOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, BUTYLOCTYL SALICYLATE, PENTYLENE GLYCOL, 1,2-HEXANEDIOL, POLYHYDROXYSTEARIC ACID, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, ALUMINA, STEARIC ACID, HYDROXYPROPYL METHYLCELLULOSE STEAROXY ETHER, POLYACRYLATE CROSSPOLYMER-6, ETHYLHEXYLGLYCERIN, T-BUTYL ALCOHOL, TOCOPHEROL

Questions?

POSTMARKETING EXPERIENCE SECTION

support@us.amorepacific.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Innisfree

Gentle Care

for Sensitive Skin

Sunscreen

Braod Spectrum SPF 29

40 mL / 1.35 Fl. Oz.

11

22

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71220-08471220-084-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
PROPANEDIOL5965N8W85TIACT
PENTYLENE GLYCOL50C1307PZGIACT
STEARIC ACID4ELV7Z65APIACT
ALUMINUM OXIDELMI26O6933IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
TERT-BUTYL ALCOHOLMD83SFE959IACT
TOCOPHEROLR0ZB2556P8IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
WATER059QF0KO0RIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT

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
0b52ec38-ed7a-5edd-e063-6294a90a0278a51530af-3f54-833c-e053-2a95a90a16292023-11-29WarningsExact identifier
spl set id: a51530af-3f54-833c-e053-2a95a90a1629

Reported adverse events (FAERS/openFDA)#

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