TIBENA EVERY DAY REAL SUNSTICK UV SPF 52- avobenzone, ethylhexyl salicylate, homosalate, octocrylene stick

TIBENA EVERY DAY REAL SUNSTICK UV SPF 52 by

Drug Labeling and Warnings

TIBENA EVERY DAY REAL SUNSTICK UV SPF 52 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%

Ethylhexyl Salicylate 5%

Homosalate 10%

Octocrylene 10%

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 a 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 from excessive heat and 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

Dimethicone, Ceresin, Butyloctyl Salicylate, Methyl Methacrylate Crosspolymer, C12-15 Alkyl Benzoate,
Silica, Cetyl Ethylhexanoate, Euphorbia Cerifera (Candelilla) Wax, Ethylhexyl Methoxycrylene, Water,
Ozokerite, Synthetic Beeswax, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer,
Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Bisabolol, 1,2-Hexanediol, Hydroxyacetophenone,
Butylene Glycol, Tocopheryl Acetate, Adenosine, Lavandula Angustifolia Flower Extract, Monarda Didyma Leaf Extract,
Mentha Piperita Leaf Extract, Freesia Refracta Extract, Chamomilla Recutita Flower Extract, Rosmarinus Officinalis Leaf Extract,
Caprylyl Glycol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TIBENA EVERY DAY REAL SUNSTICK UV SPF 52 
avobenzone, ethylhexyl salicylate, homosalate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74740-052
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 g  in 20 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.6 g  in 20 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	2 g  in 20 g
ETHYLHEXYL SALICYLATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	ETHYLHEXYL SALICYLATE	1 g  in 20 g

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
ROSEMARY (UNII: IJ67X351P9)
MONARDA DIDYMA LEAF (UNII: JY15982UBB)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
CERESIN (UNII: Q1LS2UJO3A)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
LAURYL POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: H49Q67JS3B)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
EUPHORBIA CERIFERA (CANDELILLA) WAX (UNII: WL0328HX19)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
SILICA (UNII: ETJ7Z6XBU4)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
BISABOLOL (UNII: 24WE03BX2T)
ADENOSINE (UNII: K72T3FS567)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74740-052-02	1 in 1 BOX	01/02/2025
1	NDC: 74740-052-01	20 g in 1 APPLICATOR; 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	01/02/2025

Labeler - KONAD CO LTD (688329887)

Establishment
Name	Address	ID/FEI	Business Operations
KONAD CO LTD		688329887	manufacture(74740-052)