FDA.reportPublic FDA data

BE THE SKIN NATURAL BASE SUN

Manufacturer
BETHESKIN Co.,Ltd | Liebecos Co., Ltd
Effective date
2019-02-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:58:32

Label at a glance#

ProductBE THE SKIN NATURAL BASE SUN
Active ingredientOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.00%
Titanium Dioxide 5.30%
Zinc Oxide 3.90%

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

Helps prevent sunburn

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure. Reapply at least every two hours

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

Magnolia Liliflora Bud Extract, Cyclopentasiloxane, Water, Butylene Glycol, C12-15 Alkyl Benzoate, Isoamyl p-Methoxycinnamate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Disteardimonium Hectorite, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Glyceryl Behenate/Eicosadioate, Sodium Chloride, Triethoxycaprylylsilane, Mica, Methyl Methacrylate Crosspolymer, Cyclomethicone, Hydrogen Dimethicone, Hydrated Silica, Aluminum Hydroxide, Propylene Glycol Isostearate, Aluminum Stearate, Polyhydroxystearic Acid, Alumina, Scutellaria Baicalensis Root Extract, Paeonia Suffruticosa Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Laurus Nobilis Leaf Extract, Artemisia Umbelliformis Extract, Buddleja Davidii Extract, Thymus Vulgaris (Thyme) Flower/Leaf Extract, Aloe Barbadensis Leaf Extract, Honey Extract, Royal Jelly Extract, Tocopheryl Acetate, Stearyl Glycyrrhetinate, Disodium EDTA, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Fragrance

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72802-001-022021-01-29C16284748780-1ba0f9c33-4d1e-a910-e053-dadaa90a0b8572802_001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72802-001-01BE THE SKIN NATURAL BASE SUN50 g in 1 CONTAINERCREAM501
72802-001-02BE THE SKIN NATURAL BASE SUN1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72802-001BE THE SKIN NATURAL BASE SUN (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BETHESKIN CO.,LTD]1Legacy NDC, 2 package rows20190214_39ff9fdb-6faa-4275-ab74-b2b69206e61a.zip

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72802-00172802-001-01, 72802-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
MAGNOLIA LILIIFLORA WHOLEGDO2997SZZIACT
CYCLOMETHICONE 50THT5PCI0RIACT
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
BEMOTRIZINOLPWZ1720CBHIACT
AMILOXATE376KTP06K8IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE25G622K2RAIACT
PAEONIA X SUFFRUTICOSA ROOT7M7E9A2C8JIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
SCUTELLARIA BAICALENSIS ROOT7J95K7ID2SIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3)G300307ZXPIACT
CYCLOMETHICONENMQ347994ZIACT
SODIUM CHLORIDE451W47IQ8XIACT
ALUMINUM OXIDELMI26O6933IACT
ALUMINUM STEARATEU6XF9NP8HMIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
GLYCERYL BEHENATE/EICOSADIOATE73CJJ317SRIACT
HYDROGEN DIMETHICONE (13 CST)4QGR4P2YOIIACT
HYDRATED SILICAY6O7T4G8P9IACT
ROYAL JELLYL497I37F0CIACT
MICAV8A1AW0880IACT
STEARYL GLYCYRRHETINATE3YYE6VJS0PIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER657L0NC5MTIACT
EDETATE DISODIUM7FLD91C86KIACT
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM

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
81c14d65-845d-4de8-e053-2991aa0ab08e39ff9fdb-6faa-4275-ab74-b2b69206e61a2019-02-13WarningsExact identifier
spl id: 81c14d65-845d-4de8-e053-2991aa0ab08e
spl set id: 39ff9fdb-6faa-4275-ab74-b2b69206e61a

Reported adverse events (FAERS/openFDA)#

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