FDA.reportPublic FDA data

Fikia Marine Eclipse Sun Block SPF 50 PA

Manufacturer
Beauty Line Co., Ltd. | Biocostech Co., Ltd.
Effective date
2014-10-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:40:39

Label at a glance#

ProductFikia Marine Eclipse Sun Block SPF 50 PA
Active ingredientTITANIUM DIOXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

titanium dioxide


INACTIVE INGREDIENT SECTION

water, glycerin, zinc oxide, bentonite, sodium chloride, butylene glycol, disodium edta, fragrance, etc


OTC - PURPOSE SECTION

protect the skin againse the harmful UV rays


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out or reach of the children


INDICATIONS & USAGE SECTION

apply evenly on exposed areas after daily skin-care routine


WARNINGS SECTION

-If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately
-This product is for exeternal use only. Do not use for internal use
-If possible, avoid direct sunlight and store in cool and area of low humidity
-In order to maintain the quality of the product and avoid misuse
-Avoid placing the product near fire and store out in reach of children


DOSAGE & ADMINISTRATION SECTION

for external use only


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label
package label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69327-3001-12020-01-31C16284748780-19d75b9d0-0cfd-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69327-3001-1Fikia Marine Eclipse Sun Block SPF 50 PA40 mL in 1 TUBECREAM401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69327-3001FIKIA MARINE ECLIPSE SUN BLOCK SPF 50 PA (TITANIUM DIOXIDE) CREAM [BEAUTY LINE CO., LTD.]1Legacy NDC, 1 package rows20141026_2ec3113d-2c1d-4d7a-85bb-b0f16c1017be.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69327-300169327-3001-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
HYALURONATE SODIUMYSE9PPT4THIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 7 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THINJECTION, SUSPENSION / INTRAMUSCULAR23 mgExact identifier — unii candidate
5 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii candidate
2 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THLOTION / TOPICAL0.01 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THGEL / TOPICAL463 mgExact identifier — unii candidate
5 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THINJECTION, SUSPENSION / INTRA-ARTICULAR23 mgExact identifier — unii candidate
5 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TRANSDERMAL8.12 mgExact identifier — unii candidate
2 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THINJECTION, SUSPENSION / INTRAVITREAL23 mgExact identifier — unii candidate
5 equally ranked IID candidates

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
89348ef4-5656-49ee-8ce6-17e609259c5c2ec3113d-2c1d-4d7a-85bb-b0f16c1017be2014-10-25WarningsExact identifier
spl id: 89348ef4-5656-49ee-8ce6-17e609259c5c
spl set id: 2ec3113d-2c1d-4d7a-85bb-b0f16c1017be

Reported adverse events (FAERS/openFDA)#

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