TIBENA ALWAYS REAL SUN BLOCK UV SPF 45

Manufacturer
KONAD CO LTD
Effective date
2025-01-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:50:37

Key Label Information#

Active Ingredients And Purpose

Active ingredients

Avobenzone 3% Ethylhexyl Salicylate 5% Homosalate 10% Octocrylene 10%

Purpose

sunscreen

Uses

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

Warnings

For external use only

Do not use

• on damaged skin or broken skin

Directions And Dosage

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 Label Information

Inactive ingredients

Water, Butylene Glycol, Butyloctyl Salicylate, Polyglyceryl-6 Stearate, Ethylhexyl Methoxycrylene, Niacinamide, Poly C10-30 Alkyl Acrylate, Sorbitan Sesquioleate, Silica, Behenyl Alcohol, 1,2-Hexanediol, Hydroxyacetophenone, 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

Label Images#

TIBENA ALWAYS REAL SUN BLOCK 45
TIBENA ALWAYS REAL SUN BLOCK 45

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74740-045-01TIBENA ALWAYS REAL SUN BLOCK UV SPF 4550 g in 1 TUBECREAM501
74740-045-02TIBENA ALWAYS REAL SUN BLOCK UV SPF 451 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74740-045TIBENA ALWAYS REAL SUN BLOCK UV SPF 45 (AVOBENZONE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENE) CREAM [KONAD CO LTD]1Current NDC, 2 package rows20250105_2aafbd33-710a-201e-e063-6294a90ab1bb.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74740-04574740-045-01, 74740-045-02

Ingredients#

Complete SPL Sections#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3% Ethylhexyl Salicylate 5% Homosalate 10% Octocrylene 10%

Purpose

OTC - PURPOSE SECTION

sunscreen

Uses

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

• on damaged skin or broken skin

When using this product

OTC - WHEN USING SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

■ 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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

Water, Butylene Glycol, Butyloctyl Salicylate, Polyglyceryl-6 Stearate, Ethylhexyl Methoxycrylene, Niacinamide, Poly C10-30 Alkyl Acrylate, Sorbitan Sesquioleate, Silica, Behenyl Alcohol, 1,2-Hexanediol, Hydroxyacetophenone, 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

Source Document#

Source XML