TIBENA EVERY DAY REAL SUNSCREEN SPF50- avobenzone, homosalate, octinoxate, octocrylene, octyl salicylate cream

TIBENA EVERY DAY REAL SUNSCREEN SPF50 by

Drug Labeling and Warnings

TIBENA EVERY DAY REAL SUNSCREEN SPF50 by is a Otc medication manufactured, distributed, or labeled by KONAD CO LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3.0%

Homosalate 10.0%

Octinoxate 7.0%

Octocrylene 10.0%

Octyl Salicylate 5.0%

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, Polyglyceryl-6 Stearate, Ethylhexyl Methoxycrylene, Niacinamide, Poly C10-30 Alkyl Acrylate, Silica, Sorbitan Sesquioleate, Behenyl Alcohol, 1,2-Hexanediol, Hydroxyacetophenone, Polysorbate 60, Sodium, Polyacryloyldimethyl Taurate, Polyglyceryl-6 Behenate, Polyacrylate Crosspolymer-6, Sphingomonas Ferment Extract, Tocopheryl Acetate, Panthenol, Disodium EDTA, Adenosine, Centella Asiatica Extract, Monarda Didyma Leaf Extract, Mentha Piperita Leaf Extract, Lavandula Angustifolia Flower Extract, Freesia Refracta Extract, Rosmarinus Officinalis Leaf Extract, Chamomilla Recutita Flower Extract, Asiaticoside, Caprylyl Glycol, Madecassoside, Madecassic Acid, Asiatic Acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TIBENA EVERY DAY REAL SUNSCREEN SPF50 
avobenzone, homosalate, octinoxate, octocrylene, octyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74740-460
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.5 g  in 50 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 g  in 50 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 50 g
ETHYLHEXYL SALICYLATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	ETHYLHEXYL SALICYLATE	2.5 g  in 50 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
PANTHENOL (UNII: WV9CM0O67Z)
MONARDA DIDYMA LEAF (UNII: JY15982UBB)
ROSEMARY (UNII: IJ67X351P9)
MADECASSOSIDE (UNII: CQ2F5O6YIY)
POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T)
SILICA (UNII: ETJ7Z6XBU4)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
NIACINAMIDE (UNII: 25X51I8RD4)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
BEHENYL ALCOHOL (UNII: 9G1OE216XY)
SODIUM POLYACRYLOYLDIMETHYL TAURATE (UNII: NG5NG5733T)
POLYGLYCERYL-6 BEHENATE (UNII: 4T2L7QI313)
POLYACRYLATE CROSSPOLYMER-6 (UNII: Q7UI015FF9)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASIATICOSIDE (UNII: PKO39VY215)
ADENOSINE (UNII: K72T3FS567)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
POLYSORBATE 60 (UNII: CAL22UVI4M)
MADECASSIC ACID (UNII: M7O1N24J82)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74740-460-02	1 in 1 BOX	06/22/2025
1	NDC: 74740-460-01	50 g in 1 BOTTLE, PLASTIC; 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	06/22/2025

Labeler - KONAD CO LTD (688329887)

Establishment
Name	Address	ID/FEI	Business Operations
KONAD CO LTD		688329887	manufacture(74740-460)