LABNO 4SP SAFE TONE UP SUN- titanium dioxide cream

LabNo 4SP Safe Tone Up Sun by

Drug Labeling and Warnings

LabNo 4SP Safe Tone Up Sun by is a Otc medication manufactured, distributed, or labeled by KB Lab Co., Ltd., Kolmar Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Titanium Dioxide 2.52%

INACTIVE INGREDIENT

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

Purpose: Sunscreen

WARNINGS

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

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

INGREDIENTS AND APPEARANCE

LABNO 4SP SAFE TONE UP SUN 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71497-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	1.26 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Dibutyl Adipate (UNII: F4K100DXP3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71497-010-02	1 in 1 CARTON	06/01/2017
1	NDC: 71497-010-01	50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2017

Labeler - KB Lab Co., Ltd. (694703258)

Registrant - KB Lab Co., Ltd. (694703258)

Establishment
Name	Address	ID/FEI	Business Operations
KB Lab Co., Ltd.		694703258	relabel(71497-010)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd.		689512611	manufacture(71497-010)