SEKKISEI HERBAL UV DEFENSE GEL BROAD SPECTRUM SPF40

Manufacturer
COSMAX USA, CORPORATION
Effective date
2024-12-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:49:40

Key Label Information#

Active Ingredients And Purpose

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Homosalate 9.5% Octisalate 5% Avobenzone 3.0% Octocrylene 2.6%

OTC - PURPOSE SECTION

Purpose Sunscreen

Uses

USES

Uses Helps prevent sunburn

Warnings

WARNINGS

Warnings For external use only.

Directions And Dosage

DIRECTIONS

Directions Apply liberally 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating Reapply at least every 2 hours • 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: Ask a doctor

Other Label Information

INACTIVE INGREDIENT SECTION

Inactive Ingredients Water, Isoamyl Laurate, Glycerin, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Polyglyceryl-10 Stearate, Poly C10-30 Alkyl Acrylate, Polyhydroxystearic Acid, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Cetearyl Olivate, Sorbitan Olivate, Hydroxyacetoph-enone, Phenoxyethanol, Polyglyceryl-10 Laurate, Microcrystalline Cellulose, Limonene, Rubus Idaeus (Raspberry) Seed Oil, Xanthan Gum, Glycine Soja (Soybean) Oil, Cellulose Gum, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Polyglyceryl-3 Diisostearate, Citrus Limon (Lemon) Peel Oil, Linalool, Citrus Aurantium Dulcis (Orange) Peel Oil, Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Germ Extract, Lavandula Angustifolia (Lavender) Oil, Propanediol, Ocimum Basilicum (Basil) Oil, Pelargonium Graveolens Flower Oil, Citral, Centella Asiatica Extract

Packaging Label

Label Images#

HerbalUV_SPF40_PP1
HerbalUV_SPF40_PP1
HerbalUV_SPF40_PP
HerbalUV_SPF40_PP

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68577-199-00HERBAL UV DEFENSE SPF4030 mg in 1 TUBEGEL301
68577-199-00HERBAL UV DEFENSE SPF401 in 1 CARTONGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68577-199HERBAL UV DEFENSE SPF40 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) GEL [COSMAX USA, CORPORATION]1Current NDC, 2 package rows20250101_2a76fd94-2f1f-e6d8-e063-6294a90a287c.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68577-19968577-199-00

Ingredients#

Complete SPL Sections#

OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Homosalate 9.5% Octisalate 5% Avobenzone 3.0% Octocrylene 2.6%

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

Purpose Sunscreen

USES

INDICATIONS & USAGE SECTION

Uses Helps prevent sunburn

WARNINGS

WARNINGS SECTION

Warnings For external use only.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Directions Apply liberally 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating Reapply at least every 2 hours • 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: Ask a doctor

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

Inactive Ingredients Water, Isoamyl Laurate, Glycerin, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Polyglyceryl-10 Stearate, Poly C10-30 Alkyl Acrylate, Polyhydroxystearic Acid, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Cetearyl Olivate, Sorbitan Olivate, Hydroxyacetoph-enone, Phenoxyethanol, Polyglyceryl-10 Laurate, Microcrystalline Cellulose, Limonene, Rubus Idaeus (Raspberry) Seed Oil, Xanthan Gum, Glycine Soja (Soybean) Oil, Cellulose Gum, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Polyglyceryl-3 Diisostearate, Citrus Limon (Lemon) Peel Oil, Linalool, Citrus Aurantium Dulcis (Orange) Peel Oil, Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Germ Extract, Lavandula Angustifolia (Lavender) Oil, Propanediol, Ocimum Basilicum (Basil) Oil, Pelargonium Graveolens Flower Oil, Citral, Centella Asiatica Extract

OTHER INFORMATION

OTHER SAFETY INFORMATION

Other information Protect this product from excessive heat and direct sun

Packaging Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML