FDA.reportPublic FDA data

innisfree Daily UV Defense Sunscreen

Manufacturer
Innisfree Corporation
Effective date
2024-07-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:59:17

Label at a glance#

Productinnisfree Daily UV Defense Sunscreen
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE
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 causes 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, espe...

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

Avobenzone 2.5%

Homosalate 7.0%

Octisalate 4.3%

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 causes by the sun

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damanged 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 product is 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 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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER / AQUA / EAU, BUTYLENE GLYCOL, CYCLOPENTASILOXANE, BUTYLOCTYL SALICYLATE, ETHYLHEXYL METHOXYCRYLENE, ARACHIDYL ALCOHOL, BEHENYL ALCOHOL, GLYCERYL STEARATE, PEG-100 STEARATE, 1,2-HEXANEDIOL, POLYMETHYLSILSESQUIOXANE, CETYL ALCOHOL, ARACHIDYL GLUCOSIDE, PHENOXYETHANOL, PROPANEDIOL, POLYACRYLATE CROSSPOLYMER-6, OCTYLDODECANOL, FRAGRANCE / PARFUM, XANTHAN GUM, CENTELLA ASIATICA EXTRACT, PORTULACA OLERACEA EXTRACT, ECHIUM PLANTAGINEUM SEED OIL, T-BUTYL ALCOHOL, CAMELLIA SINENSIS LEAF EXTRACT, ETHYLHEXYLGLYCERIN, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES, CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT, TOCOPHEROL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, GLYCERIN, HAMAMELIS VIRGINIANA (WITCH HAZEL) LEAF EXTRACT, CITRUS UNSHIU PEEL EXTRACT, OPUNTIA COCCINELLIFERA FRUIT EXTRACT, ORCHID EXTRACT, CAMELLIA JAPONICA LEAF EXTRACT, CITRIC ACID, SODIUM BENZOATE, POTASSIUM SORBATE

Other information

STORAGE AND HANDLING SECTION

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

Questions?

POSTMARKETING EXPERIENCE SECTION

support@us.amorepacific.com

Innisfree Hydrate & Protect

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

innisfree

Hydrate

& Protect

Sunscreen

Facial Serum

Facial Cream

Net Contents of Kit

3.38 Fl. Oz. / 100 mL

PDPPDP

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71220-085INNISFREE DAILY UV DEFENSE SUNSCREEN (AVOBENZONE, HOMOSALATE, AND OCTISALATE LOTION) LOTION [INNISFREE CORPORATION]3Unmatched20240711_02ab23ef-f933-9ee8-e063-6394a90a2030.zip

Products#

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

DailyMed product names page 1 of 2 · 41 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71220-08571220-085-99

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
DOCOSANOL9G1OE216XYIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CETYL ALCOHOL936JST6JCNIACT
PURSLANEM6S840WXG5IACT
ECHIUM PLANTAGINEUM SEED OILPIB7XBU8XWIACT
TERT-BUTYL ALCOHOLMD83SFE959IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
GLYCERINPDC6A3C0OXIACT
TANGERINE PEELJU3D414057IACT
PHANERA VARIEGATA WHOLEB11919964FIACT
CAMELLIA JAPONICA LEAF4E3VE6KTLYIACT
SODIUM BENZOATEOJ245FE5EUIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
HAMAMELIS VIRGINIANA LEAFT07U1161SVIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PHENOXYETHANOLHIE492ZZ3TIACT
XANTHAN GUMTTV12P4NEEIACT
CENTELLA ASIATICA7M867G6T1UIACT
PROPANEDIOL5965N8W85TIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
OCTYLDODECANOL461N1O614YIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
OCTISALATE4X49Y0596WACTIB
WATER059QF0KO0RIACT
TOCOPHEROLR0ZB2556P8IACT
SUNFLOWER OIL3W1JG795YIIACT
CYCLOMETHICONE 50THT5PCI0RIACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
PEG-100 STEARATEYD01N1999RIACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
OPUNTIA COCHENILLIFERA FRUIT838ZTK02KHIACT
CARDIOSPERMUM HALICACABUM FLOWERING TOPMZP2508BRRIACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT

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
1cd7cab1-8dba-a7b7-e063-6394a90ae8f202ab23ef-f933-9ee8-e063-6394a90a20302024-07-09WarningsExact identifier
spl id: 1cd7cab1-8dba-a7b7-e063-6394a90ae8f2
spl set id: 02ab23ef-f933-9ee8-e063-6394a90a2030

Reported adverse events (FAERS/openFDA)#

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