FDA.reportPublic FDA data

IM SAFE FOR BABY AND SILVER

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 SAFE FOR BABY AND SILVER
Active ingredientTITANIUM DIOXIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

22

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Titamin Dioxide 3.57 %

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Water, Propanediol, Phenyl Trimethicone, Dicaprylyl Carbonate, Methylpropanediol, Cyclomethicone, 1,2-Hexanediol, Glycereth-26, Methyl Trimethicone, Salvia Hispanica Seed Extract, Centella Asiatica Extract, Houttuynia Cordata Extract, Polyglyceryl-2 Caprate, Methyl Methacrylate Crosspolymer, Sucrose Stearate, Fructooligosaccharides, Saccharide Hydrolysate, Simmondsia Chinensis (Jojoba) Seed Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cellulose Gum, Tromethamine, Hydroxypropyl Methylcellulose, Cetyl Hydroxyethylcellulose, Stearic Acid, Alumina, Betaine, Trehalose, Pullulan, Glyceryl Caprylate, Ethylhexylglycerin, Squalane, Butylene Glycol, Pentylene Glycol, Aloe Barbadensis Leaf Extract, Madecassoside, C12-15 Alkyl Benzoate, Sodium Hyaluronate, Aluminum Stearate, Polyhydroxystearic Acid

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

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
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72284-0005-12022-01-28C16284748780-1d6a99b39-d1b8-a426-e053-dadaa90af4c283186695-f093-45d0-e053-2a91aa0a827d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72284-0005-1IM SAFE FOR BABY AND SILVER50 mL in 1 TUBELOTION501
72284-0005-1IM SAFE FOR BABY AND SILVER1 in 1 BOXLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72284-0005IM SAFE FOR BABY AND SILVER (TITANIUM DIOXIDE) LOTION [NORMALEST CO., LTD.]1Legacy NDC, 2 package rows20190306_83186695-f093-45d0-e053-2a91aa0a827d.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
72284-000572284-0005-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
DICAPRYLYL CARBONATE609A3V1SUAIACT
METHYLPROPANEDIOLN8F53B3R4RIACT
CYCLOMETHICONENMQ347994ZIACT
SALVIA HISPANICA SEEDNU0OLX06F8IACT
FOSFRUCTOSEM7522JYX1HIACT
SIMMONDSIA CHINENSIS SEEDD24K2Q1F6HIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
TROMETHAMINE023C2WHX2VIACT
BETAINE3SCV180C9WIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
SQUALANEGW89575KF9IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PENTYLENE GLYCOL50C1307PZGIACT
MADECASSOSIDECQ2F5O6YIYIACT
INVERT SUGARED959S6ACYIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
SUCROSE STEARATE274KW0O50MIACT
TREHALOSEB8WCK70T7IIACT
PULLULAN8ZQ0AYU1TTIACT
HYALURONATE SODIUMYSE9PPT4THIACT
PROPANEDIOL5965N8W85TIACT
HYPROMELLOSES3NXW29V3WOIACT
STEARIC ACID4ELV7Z65APIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
GLYCERETH-26NNE56F2N14IACT
METHYL TRIMETHICONES73ZQI0GXMIACT
CENTELLA ASIATICA7M867G6T1UIACT
HOUTTUYNIA CORDATA WHOLEO3E12ZLW5TIACT
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMEREG97988M5QIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ALUMINUM STEARATEU6XF9NP8HMIACT

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
83186695-f094-45d0-e053-2a91aa0a827d83186695-f093-45d0-e053-2a91aa0a827d2019-03-06Exact identifier
spl id: 83186695-f094-45d0-e053-2a91aa0a827d
spl set id: 83186695-f093-45d0-e053-2a91aa0a827d

Reported adverse events (FAERS/openFDA)#

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