FDA.reportPublic FDA data

ACWELL SOLAR DEFENSE LICORICE Suncream

Manufacturer
BNHCOSMETICS CO., LTD. | Kolmar Korea Co.,LTD. Gwanjeong Factory
Effective date
2022-10-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:51:59

Label at a glance#

ProductACWELL SOLAR DEFENSE LICORICE Suncream
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE, OCTISALATE, HOMOSALATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 15.20%

Homosalate 7.5%

Octisalate 4.5%

Titanium Dioxide 2.2%

OTC - PURPOSE SECTION

Sunscreen

DOSAGE & ADMINISTRATION SECTION

- Apply liberally 15 minutes before sun exposure. Reapply at least every two 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 of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses
- Ask a doctor to use for children under 6 months

INDICATIONS & USAGE SECTION

Helps prevent sunburn

WARNINGS SECTION

For external use only

Do not use on damaged or broken skin

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

Stop using and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

INACTIVE INGREDIENT SECTION

WATER, CYCLOPENTASILOXANE, HOMOSALATE, PROPANEDIOL, ETHYLHEXYL SALICYLATE, BUTYLOCTYL SALICYLATE, LAURYL PEG-10 TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE, NIACINAMIDE, CAPRYLYL METHICONE, VERONICA OFFICINALIS EXTRACT, POTERIUM OFFICINALE ROOT EXTRACT, PINUS SYLVESTRIS BUD EXTRACT, GLYCYRRHIZA URALENSIS (LICORICE) ROOT EXTRACT, NELUMBIUM SPECIOSUM FLOWER EXTRACT, SOLIDAGO VIRGAUREA (GOLDENROD) EXTRACT, EUGENIA CARYOPHYLLUS (CLOVE) BUD EXTRACT, ARTEMISIA VULGARIS OIL, SODIUM HYALURONATE, GLYCYRRHIZA GLABRA (LICORICE) ROOT WATER, CALCIUM ALUMINUM BOROSILICATE, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, DIMETHICONE, 1,2-HEXANEDIOL, POLYMETHYLSILSESQUIOXANE, TRIETHOXYCAPRYLYLSILANE, STEARIC ACID, ALUMINUM HYDROXIDE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, BUTYLENE GLYCOL, GLYCERYL CAPRYLATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, ADENOSINE, DIPROPYLENE GLYCOL, SODIUM CITRATE, TOCOPHEROL, SILICA, C12-15 ALKYL BENZOATE, CERIUM OXIDE, HYDROGEN DIMETHICONE, POLYHYDROXYSTEARIC ACID)

OTHER SAFETY INFORMATION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Products#

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

DailyMed product names page 1 of 2 · 46 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71597-01171597-011-01, 71597-011-02

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 43 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
PROPANEDIOL5965N8W85TIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
NIACINAMIDE25X51I8RD4IACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
CALCIUM ALUMINUM BOROSILICATE3JRB8A35M0IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
DIMETHICONE92RU3N3Y1OIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
DIMETHICONE/PEG-10/15 CROSSPOLYMER21AS8B1BSSIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
GLYCERYL MONOCAPRYLATETM2TZD4G4AIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)H895X08VNQIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ARTEMISIA VULGARIS TOP OIL72Q967Y48VIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ADENOSINEK72T3FS567IACT
HYALURONATE SODIUMYSE9PPT4THIACT
SANGUISORBA OFFICINALIS ROOT4NYV2HT01XIACT
VERONICA OFFICINALIS FLOWERING TOP9IH82J936JIACT
DIPROPYLENE GLYCOLE107L85C40IACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
TOCOPHEROLR0ZB2556P8IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CERIC OXIDE619G5K328YIACT
HYDROGEN DIMETHICONE (30 CST)JF2ZJ6R2WDIACT
PINUS SYLVESTRIS LEAFY TWIGQ1RGP4UB73IACT
NELUMBO NUCIFERA FLOWER61W322NLDVIACT
GLYCYRRHIZA URALENSIS ROOT42B5YD8F0KIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
CLOVEK48IKT5321IACT
SOLIDAGO VIRGAUREA FLOWERING TOP5405K23S50IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB

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
facdf884-099e-f6a9-e053-6394a90ab7da422ebb58-fd31-4967-ad3e-514575ddc8782023-05-03WarningsExact identifier
spl set id: 422ebb58-fd31-4967-ad3e-514575ddc878

Reported adverse events (FAERS/openFDA)#

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