FDA.reportPublic FDA data

IM SAFE FOR SENSITIVE SKIN

Manufacturer
Normalest Co., Ltd.
Effective date
2019-04-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:59:19

Label at a glance#

ProductIM SAFE FOR SENSITIVE SKIN
Active ingredientTITANIUM DIOXIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IMSAFEIMSAFE

Active Ingredients

Titanium Dioxide

Inactive Ingredients

Water, Propanediol, Phenyl Trimethicone, Dicaprylyl Carbonate, Methylpropanediol, Cyclopentasiloxane,1,2-Hexanediol, Glycereth-26, Methyl Trimethicone, Polyglyceryl-2 Caprate, Methyl Methacrylate Crosspolymer, Styrene/Acrylates Copolymer ,Sucrose Stearate, Tromethamine, Simmondsia Chinensis (Jojoba) Seed Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cellulose Gum, Hydroxypropyl Methylcellulose, Cetyl Hydroxyethylcellulose, Stearic Acid, Alumina, Betaine, Trehalose, Glyceryl Caprylate, Butylene Glycol, Pentylene Glycol, Ethylhexylglycerin, Squalane, Centella Asiatica Extract, Aloe Barbadensis Leaf Extract, Madecassoside, Butylene Glycol Dicaprylate/Dicaprate, Carbomer, Polyacrylate Crosspolymer-6, t-Butyl Alcohol

OTC - ACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

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

DOSAGE & ADMINISTRATION SECTION

WARNINGS SECTION

OTHER SAFETY INFORMATION

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72284-0007-12022-01-28C16284748780-1d6a99b39-d1df-a426-e053-dadaa90af4c287325bf8-430b-0740-e053-2a91aa0a835c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72284-0007-1IM SAFE FOR SENSITIVE SKIN1 in 1 BOXLOTION11
72284-0007-1IM SAFE FOR SENSITIVE SKIN50 mL in 1 TUBELOTION501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72284-0007IM SAFE FOR SENSITIVE SKIN (TITANIUM DIOXIDE) LOTION [NORMALEST CO., LTD.]1Legacy NDC, 2 package rows20190424_87325bf8-430b-0740-e053-2a91aa0a835c.zip

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72284-000772284-0007-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCROSE STEARATE274KW0O50MIACT
BETAINE3SCV180C9WIACT
TREHALOSEB8WCK70T7IIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
PENTYLENE GLYCOL50C1307PZGIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SQUALANEGW89575KF9IACT
CENTELLA ASIATICA7M867G6T1UIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
TERT-BUTYL ALCOHOLMD83SFE959IACT
WATER059QF0KO0RIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
PROPANEDIOL5965N8W85TIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
METHYLPROPANEDIOLN8F53B3R4RIACT
METHYL TRIMETHICONES73ZQI0GXMIACT
JOJOBA OIL724GKU717MIACT
TROMETHAMINE023C2WHX2VIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ALOE VERA LEAFZY81Z83H0XIACT
MADECASSOSIDECQ2F5O6YIYIACT
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE75D21FL1PIIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
HYPROMELLOSES3NXW29V3WOIACT
STEARIC ACID4ELV7Z65APIACT
ALUMINUM OXIDELMI26O6933IACT
GLYCERETH-26NNE56F2N14IACT
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMEREG97988M5QIACT

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
87325bf8-430c-0740-e053-2a91aa0a835c87325bf8-430b-0740-e053-2a91aa0a835c2019-04-23Exact identifier
spl id: 87325bf8-430c-0740-e053-2a91aa0a835c
spl set id: 87325bf8-430b-0740-e053-2a91aa0a835c

Reported adverse events (FAERS/openFDA)#

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