LabNo 4SP Safe Tone Up Sun

Manufacturer
KB Lab Co., Ltd. | Kolmar Korea Co., Ltd.
Effective date
2017-07-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:51:54

Label at a glance#

ProductLabNo 4SP Safe Tone Up Sun
Active ingredientTitanium Dioxide
Label structure6 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredients: Titanium Dioxide 2.52%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients: Water, Dibutyl Adipate, C12-15 Alkyl Benzoate, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Butyloctyl Salicylate, Polysilicone-15, 1,2-Hexanediol, Ethylhexyl Triazone, Behenyl Alcohol, Arachidyl Alcohol, Cetearyl Alcohol, Butylene Glycol, Silica, Glyceryl Stearate, Cetyl Alcohol, Arachidyl Glucoside, Propanediol, Octyldodecanol, Sodium Stearoyl Glutamate, Polyglyceryl-2 Caprate, Polyacrylate Crosspolymer-6, Saccharide Hydrolysate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sucrose Stearate, Xanthan Gum, Simmondsia Chinensis (Jojoba) Seed Oil, Stearic Acid, Alumina, Ethylhexylglycerin, Glyceryl Caprylate, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Echium Plantagineum Seed Oil, Pelargonium Graveolens Flower Oil, Portulaca Oleracea Extract, Centella Asiatica Extract, Squalane, Houttuynia Cordata Extract, Curcuma Longa (Turmeric) Root Extract, Salvia Hispanica Seed Extract, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, T-Butyl Alcohol, Salvia Officinalis (Sage) Oil, Pogostemon Cablin Oil, Tocopherol, Camellia Japonica Flower Extract, Prunus Serrulata Flower Extract, Acer Saccharum (Sugar Maple) Extract, Rose Extract, Soluble Collagen, Arginine, Ceramide Np, Elastin

PURPOSE

OTC - PURPOSE SECTION

Purpose: Sunscreen

WARNINGS

WARNINGS SECTION

Warnings: For external use only Avoid contact with eyes. Rinse with water to remove. Discontinue use and consult a doctor if signs of irritation or rashes appear. Replace the cap after use.

Keep Out of Reach of Children: If swallowed, get medical help or contact a Poison Control Center immediately.

DESCRIPTION

DESCRIPTION SECTION

Uses:

- Helps to prevent sunburn

- Helps to provide sun protection

- Higher SPF provides strong sun protection

Directions:

- Apply generously as needed.

- Reapply as needed or after towel drying, swimming or sweating.

- Children under 6 months of age: Ask a doctor.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71497-010-022020-01-31C16284748780-19d75b9d0-b7a6-f424-e053-dadaa90a57ce326264eb-af49-4c8c-ba5a-b4d07a5ab50c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71497-010-01LabNo 4SP Safe Tone Up Sun50 mL in 1 TUBECREAM501
71497-010-02LabNo 4SP Safe Tone Up Sun1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71497-010LABNO 4SP SAFE TONE UP SUN (TITANIUM DIOXIDE) CREAM [KB LAB CO., LTD.]1Legacy NDC, 2 package rows20170711_326264eb-af49-4c8c-ba5a-b4d07a5ab50c.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71497-01071497-010-01, 71497-010-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
Water059QF0KO0RIACT
Dibutyl AdipateF4K100DXP3IACT

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
15c89c14-9ee4-4941-bf36-b0ebb8690ab0326264eb-af49-4c8c-ba5a-b4d07a5ab50c2017-07-11WarningsExact identifier
spl id: 15c89c14-9ee4-4941-bf36-b0ebb8690ab0
spl set id: 326264eb-af49-4c8c-ba5a-b4d07a5ab50c

Reported adverse events (FAERS/openFDA)#

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