FDA.reportPublic FDA data

IM PURE CICA SUNSCREEN

Manufacturer
Normalest Co., Ltd.
Effective date
2019-03-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:58:42

Label at a glance#

ProductIM PURE CICA SUNSCREEN
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Zinc Oxide (11.6%)

Titanium Dioxide (3.1%)

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Water, Cyclomethicone, Hydrogen Dimethicone, Aluminum Hydroxide, Stearic Acid, Dicaprylyl Carbonate, Propanediol, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Dimethicone Crosspolymer, Phenyl Trimethicone, Salvia Hispanica Seed Extract, Centella Asiatica Extract, Houttuynia Cordata Extract, 1,2-Hexanediol, Saccharide Hydrolysate, Fructooligosaccharides, Pullulan, Cetyl Ethylhexanoate, Disteardimonium Hectorite, Magnesium Sulfate, Polyglyceryl-2 Dipolyhydroxystearate, Helianthus Annuus (Sunflower) Seed Oil, Anthemis Nobilis Flower Oil, Ethylhexylglycerin, Octyldodecanol, Echium Plantagineum Seed Oil, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Tocopherol, Galactomyces Ferment Filtrate, Butylene Glycol, Pentylene Glycol, Caprylyl Glycol, Madecassoside

OTC - ASK DOCTOR SECTION

OTC - ASK DOCTOR/PHARMACIST SECTION

OTC - DO NOT USE SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - PURPOSE SECTION

OTC - STOP USE SECTION

OTC - WHEN USING SECTION

WARNINGS SECTION

DOSAGE & ADMINISTRATION SECTION

OTHER SAFETY INFORMATION

STATEMENT OF IDENTITY SECTION

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72284-0004-12022-01-28C16284748780-1d6a99b39-b8c8-a426-e053-dadaa90af4c283152174-d211-ab65-e053-2a91aa0a489f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72284-0004-1IM PURE CICA SUNSCREEN1 in 1 BOXLOTION11
72284-0004-1IM PURE CICA SUNSCREEN50 mL in 1 TUBELOTION501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72284-0004IM PURE CICA SUNSCREEN (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [NORMALEST CO., LTD.]1Legacy NDC, 2 package rows20190306_83152174-d211-ab65-e053-2a91aa0a489f.zip

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72284-000472284-0004-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
1,2-HEXANEDIOLTR046Y3K1GIACT
SUNFLOWER SEED OIL GLYCERETH-8 ESTERS358X17CAT0IACT
CHAMOMILE FLOWER OIL60F80Z61A9IACT
CARDIOSPERMUM HALICACABUM WHOLE185RQ97K0VIACT
MADECASSOSIDECQ2F5O6YIYIACT
HYDROGEN DIMETHICONE (13 CST)4QGR4P2YOIIACT
STEARIC ACID4ELV7Z65APIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
CENTELLA ASIATICA LEAF6810070TYDIACT
INVERT SUGARED959S6ACYIACT
CETYL ETHYLHEXANOATE134647WMX4IACT
MAGNESIUM SULFATE ANHYDROUSML30MJ2U7IIACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
OCTYLDODECANOL461N1O614YIACT
ECHIUM PLANTAGINEUM SEED OILPIB7XBU8XWIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
CYCLOMETHICONENMQ347994ZIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
PROPANEDIOL5965N8W85TIACT
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S)RLA2U05Z4QIACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
SALVIA HISPANICA SEEDNU0OLX06F8IACT
HOUTTUYNIA CORDATA WHOLEO3E12ZLW5TIACT
PULLULAN8ZQ0AYU1TTIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
TOCOPHEROLR0ZB2556P8IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PENTYLENE GLYCOL50C1307PZGIACT
CAPRYLYL GLYCOL00YIU5438UIACT
FOSFRUCTOSEM7522JYX1HIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

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
83152174-d212-ab65-e053-2a91aa0a489f83152174-d211-ab65-e053-2a91aa0a489f2019-03-06Exact identifier
spl id: 83152174-d212-ab65-e053-2a91aa0a489f
spl set id: 83152174-d211-ab65-e053-2a91aa0a489f

Reported adverse events (FAERS/openFDA)#

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