TIBENA EVERY DAY REAL SUN BLOCK- titanium dioxide, zinc oxide cream

TIBENA EVERY DAY REAL SUN BLOCK by

Drug Labeling and Warnings

TIBENA EVERY DAY REAL SUN BLOCK by is a Otc medication manufactured, distributed, or labeled by KONAD CO LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Titanium Dioxide 3.12 %

Zinc Oxide 19.2 %

Purpose

sunscreen

Uses

helps prevent sunburn

if used as directed with other sun protection measures ( see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only

Do not use

· on damaged skin or broken skin.

When using this product

· keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

· rash occurs.

Keep out of reach of children

If swallowed, get medical help or contact Poison Control Center right away.

Directions

■ Apply liberally 15 minutes before sun exposure.
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
·limit time in the sun, especially from 10 a.m. – 2 p.m.
·wear long-sleeved shirts, pants, hats, and sunglasses
■ Children under 6 months of age: Ask a doctor
■ Reapply at least every 2 hours.
■ Use a water-resistant sunscreen if swimming or sweating.

Other information

■ Protect the product in this container form excessive heat or direct sun. ■ Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Inactive ingredients

Water, Butylene Glycol, Butyloctyl Salicylate, Cetyl Ethylhexanoate, Ethylhexyl Methoxycrylene, Niacinamide, Stearic Acid, Polyglyceryl-3 Methylglucose Distearate, 1,2-Hexanediol, Cetearyl Alcohol, Glyceryl Stearate, Polyglyceryl-10 Oleate, Gluconolactone, Polyglyceryl-4 Oleate, Triethoxycaprylylsilane, Aluminum Hydroxide, Caprylyl Glycol, Sodium Polyacryloyldimethyl Taurate, Sphingomonas Ferment Extract, Polyglyceryl-3 Polyricinoleate, Xanthan Gum, Tocopherol, Ethylhexylglycerin, Adenosine, Centella asiatica Extract, Lavandula Angustifolia Flower Extract, Monarda Didyma Leaf Extract, Mentha Piperita Leaf Extract, Freesia Refracta Extract, Chamomilla Recutita Flower Extract, Rosmarinus Officinalis Leaf Extract, Asiaticoside, Asiatic acid, Madecassic acid, Madecassoside

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TIBENA EVERY DAY REAL SUN BLOCK 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74740-450
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	9.6 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.56 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ADENOSINE (UNII: K72T3FS567)
MADECASSIC ACID (UNII: M7O1N24J82)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM POLYACRYLOYLDIMETHYL TAURATE (UNII: NG5NG5733T)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
TOCOPHEROL (UNII: R0ZB2556P8)
ROSEMARY (UNII: IJ67X351P9)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ASIATIC ACID (UNII: 9PA5A687X5)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (UNII: W19EIO0DBE)
WATER (UNII: 059QF0KO0R)
NIACINAMIDE (UNII: 25X51I8RD4)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYGLYCERYL-10 OLEATE (UNII: 55C81W76DH)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
POLYGLYCERYL-4 OLEATE (UNII: 15B05TY4GX)
XANTHAN GUM (UNII: TTV12P4NEE)
MONARDA DIDYMA LEAF (UNII: JY15982UBB)
ASIATICOSIDE (UNII: PKO39VY215)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
MADECASSOSIDE (UNII: CQ2F5O6YIY)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74740-450-02	1 in 1 BOX	09/09/2024
1	NDC: 74740-450-01	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 Drug	M020	09/09/2024

Labeler - KONAD CO LTD (688329887)

Establishment
Name	Address	ID/FEI	Business Operations
KONAD CO LTD		688329887	manufacture(74740-450)