FDA.reportPublic FDA data

By Pharmicell Lab Prestige Sun Block

Manufacturer
Pharmicell Co., Ltd.
Effective date
2013-11-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:37:31

Label at a glance#

ProductBy Pharmicell Lab Prestige Sun Block SPF40 PA PLUS PLUS PLUS
Active ingredientOCTINOXATE, OCTISALATE, ENSULIZOLE, AVOBENZONE
Label structure8 sections

Indications and uses

Indications and usage : At the last step of basic skin care, take a proper amount of the sun block and spread it evenly over the skin.

Dosage and administration

Dosage and administration : Take a proper amount of the product and spread it evenly over the entire face.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredient : OCTINOXATE 5.5%, OCTISALATE 5.0%, ENSULIZOLE 4.0%, AVOBENZONE 3%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredient : WATER, BUTYLENE GLYCOL, C12-15 ALKYL BENZOATE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, ARBUTIN, CETEARYL ALCOHOL, CYCLOPENTASILOXANE, CETEARYL OLIVATE, GLYCERIN, SORBITAN OLIVATE, CYCLOHEXASILOXANE, GLYCERYL STEARATE, SODIUM HYDROXIDE, DIMETHICONE, PANTHENOL, METHYL METHACRYLATE CROSSPOLYMER, VP/HEXADECENE COPOLYMER, POLYSORBATE 60, POLYACRYLATE-13, PHENOXYETHANOL, SORBITAN STEARATE, POLYISOBUTENE, DISODIUM EDTA, TOCOPHERYL ACETATE, SODIUM BENZOATE, CITRUS MEDICA LIMONUM (LEMON) PEEL OIL, PEG-100 STEARATE, POTASSIUM SORBATE, CITRUS AURANTIFOLIA (LIME) FLOWER EXTRACT, ADENOSINE, HUMAN BONE MARROW STEM CELL CONDITIONED MEDIA, PRUNUS PERSICA (PEACH) FLOWER EXTRACT, BHT, SORBITAN ISOSTEARATE, POLYSORBATE 20, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL, PYRUS MALUS (APPLE) FLOWER EXTRACT, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, 1,2-HEXANDIOL, CAPRYLYL GLYCOL, CITRUS AURANTIFOLIA (LIME) OIL, PUNICA GRANATUM FLOWER EXTRACT, PINUS SYLVESTRIS LEAF OIL, PRUNUS AVIUM (SWEET CHERRY) FLOWER EXTRACT, CITRUS AURANTIUM DULCIS (ORANGE) FLOWER EXTRACT, HYDROLYZED EXTENSIN, ALOE BARBADENSIS LEAF JUICE, EUCALYPTUS GLOBULUS LEAF OIL, ZEA MAYS (CORN) KERNEL EXTRACT, JASMINUM OFFICINALE (JASMINE) FLOWER EXTRACT, SQUALANE, PHOSPHOLIPIDS, CI 17200, PHYTOSPHINGOSINE, CERAMIDE 3, TROPOLONE, PHYTOSTEROLS, ETHYLHEXYLGLYCERIN

PURPOSE

OTC - PURPOSE SECTION

Purpose : Sunscreen

WARNINGS

WARNINGS SECTION

Warning : Keep out of reach of children and babies. For external use only. Avoid contact with eyes. Discontinue use if signs of irritation and/or rash appear.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children and babies.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Indications and usage : At the last step of basic skin care, take a proper amount of the sun block and spread it evenly over the skin.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Dosage and administration : Take a proper amount of the product and spread it evenly over the entire face.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60949-030-012019-11-27C16284748780-19855e2a2-4c59-60a7-e053-dbdaa90a05bd6f9d3195-418d-446e-817c-e0fddb68ee14

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60949-030-01By Pharmicell Lab Prestige Sun BlockSPF40 PA PLUS PLUS PLUS50 g in 1 CARTONCREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60949-030BY PHARMICELL LAB PRESTIGE SUN BLOCK SPF40 PA PLUS PLUS PLUS (OCTINOXATE, OCTISALATE, ENSULIZOLE, AVOBENZONE) CREAM [PHARMICELL CO., LTD.]1Legacy NDC, 1 package rows20131119_6f9d3195-418d-446e-817c-e0fddb68ee14.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX1
ENSULIZOLEACTIVE INGREDIENT9YQ9DI1W421
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
AVOBENZONEACTIVE MOIETYG63QQF2NOX1
ENSULIZOLEACTIVE MOIETY9YQ9DI1W421
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OCTISALATEACTIVE MOIETY4X49Y0596W1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60949-03060949-030-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
ENSULIZOLE9YQ9DI1W42ACTIB
AVOBENZONEG63QQF2NOXACTIB
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT

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 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii candidate
2 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TRANSDERMAL8.12 mgExact identifier — unii candidate
2 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
3b9ed51d-50fe-4335-89a7-d4b999be10486f9d3195-418d-446e-817c-e0fddb68ee142013-11-19WarningsExact identifier
spl id: 3b9ed51d-50fe-4335-89a7-d4b999be1048
spl set id: 6f9d3195-418d-446e-817c-e0fddb68ee14

Reported adverse events (FAERS/openFDA)#

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