Sekkisei Herbal Uv Defense Gel Broad Spectrum Spf40

Sekkisei Herbal Uv Defense Gel Broad Spectrum Spf40
SPL v1
SPL
SPL Set ID 2a76fd94-2f1f-e6d8-e063-6294a90a287c
Route
TOPICAL
Published
Effective Date 2024-01-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (9.5 mg) Octisalate (5 mg) Avobenzone (3 mg) Octocrylene (2.6 mg)
Inactive Ingredients
Methyl Trimethicone Betaine Silicon Dioxide Glycerin Caesalpinia Spinosa Fruit Pod Orange Oil, Cold Pressed .alpha.-tocopherol Acetate Aloe Vera Leaf Citrus Bioflavonoids 1,2-hexanediol Hydrolyzed Wheat Protein (enzymatic, 3000 Mw) Ammonium Acryloyldimethyltaurate/vp Copolymer Kappaphycus Alvarezii Water Butyloctyl Salicylate Lavender Oil Phenoxyethanol Caprylyl Trisiloxane Broccoli Tropaeolum Majus Flowering Top Dibutyl Ethylhexanoyl Glutamide Glycyrrhiza Glabra Butylene Glycol Angelica Gigas Root Hydroxyacetophenone Basil Oil Aminomethylpropanol Lemon Oil, Cold Pressed Edetate Disodium Coix Lacryma-jobi Var. Ma-yuen Seed Biosaccharide Gum-4 Dibutyl Lauroyl Glutamide Pelargonium Graveolens Flower Oil Propanediol Dipropylene Glycol Carbomer Homopolymer Type B (allyl Pentaerythritol Or Allyl Sucrose Crosslinked) Potassium Sorbate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-03

Description

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


Medication Information

Description

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

Uses

Uses

  • Helps prevent sunburn
Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctorif rash occurs.

Section 50567-7

When using this productkeep out of eyes. Rinse with water to remove

Section 50570-1

Do not useon damaged or broken skin.

Section 51727-6

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

Section 55105-1

Purpose

Sunscreen

Section 55106-9

Active Ingredients

Homosalate 9.5%

Octisalate 5%

Avobenzone 3.0%

Octocrylene 2.6%

Warnings

Warnings

For external use only.

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
Packaging Label

Other Information

Other information

Protect this product from excessive heat and direct sun


Structured Label Content

Uses (USES)

Uses

  • Helps prevent sunburn
Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctorif rash occurs.

Section 50567-7 (50567-7)

When using this productkeep out of eyes. Rinse with water to remove

Section 50570-1 (50570-1)

Do not useon damaged or broken skin.

Section 51727-6 (51727-6)

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

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 55106-9 (55106-9)

Active Ingredients

Homosalate 9.5%

Octisalate 5%

Avobenzone 3.0%

Octocrylene 2.6%

Warnings (WARNINGS)

Warnings

For external use only.

Directions (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
Packaging Label

Other Information (OTHER INFORMATION)

Other information

Protect this product from excessive heat and direct sun


Advanced Ingredient Data


Raw Label Data

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