SPL v2
SPL
SPL Set ID 284cadf1-deb9-4f3d-e063-6394a90ab122
Route
TOPICAL
Published
Effective Date 2025-04-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2.7 g) Homosalate (9.5 g) Octocrylene (5 g) Octisalate (4.5 g)
Inactive Ingredients
Citrus Aurantium Dulcis (orange) Peel Oil Butylene Glycol Pelargonium Graveolens Flower Oil Stearalkonium Hectorite Rosmarinus Officinalis (rosemary) Leaf Oil Mentha X Rotundifolia Leaf Pentylene Glycol Ecklonia Cava Laminaria Japonica Dicaprylyl Carbonate Propylheptyl Caprylate Butyloctyl Salicylate Polyhydroxystearic Acid (2300 Mw) Eucalyptus Globulus Leaf C12-15 Alkyl Benzoate Citral Magnesium Potassium Aluminosilicate Fluoride Dextrin Palmitate (corn; 20000 Mw) Ethylhexylglycerin Dibutyl Ethylhexanoyl Glutamide Caprylic/capric Triglyceride Tocopherol Rosa Canina Fruit Niacinamide Thymus Vulgaris (thyme) Leaf Sodium Acetylated Hyaluronate Limonene, (+)- Citronellol Geraniol Linalool Dibutyl Lauroyl Glutamide Sodium Hyaluronate Propylene Carbonate Hyaluronic Acid Octyldodecanol Water 1,2-hexanediol Ci 77491 Sargassum Fusiforme Melissa Officinalis Flowering Top

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-14

Description

Butyl Methoxydibenzolylmethane 2.7% Ethylhexyl Salicylate 4.5% Homosalate 9.5% Octocrylene 5.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Dosage and Administration

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

Description

Butyl Methoxydibenzolylmethane 2.7% Ethylhexyl Salicylate 4.5% Homosalate 9.5% Octocrylene 5.0%

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.
Section 51945-4

Stop Use

Stop use and ask a doctor if rash occurs.

Directions
  • Apply generously and evenly 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • Sun Protection Measure: 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.

*Gently twist the bottom just enough for a single use.

Do Not Use

Do not use on damaged or broken skin

When Using

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

Other Information

Protect the product in this container from excessive heat and direct sun.

Active Ingredients

Butyl Methoxydibenzolylmethane 2.7%

Ethylhexyl Salicylate 4.5%

Homosalate 9.5%

Octocrylene 5.0%

Inactive Ingredients

Octyldodecanol, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Dicaprylyl Carbonate, Propylheptyl Caprylate, Dibutyl Lauroyl Glutamide, Butyloctyl Salicylate, Dibutyl Ethylhexanoyl Glutamide, Pelargonium Graveolens Flower Oil++, Citrus Aurantium Dulcis (Orange) Peel Oil++, Hyaluronic Acid+, Hydrolyzed Hyaluronic Acid+, Sodium Hyaluronate+, Melissa Officinalis Flower/Leaf/Stem Water*, Rosmarinus Officinalis (Rosemary) Leaf Water*, Eucalyptus Globulus Leaf Extract*, Laminaria Japonica Extract**, Ecklonia Cava Extract**, Hizikia Fusiforme Extract**, Mentha Rotundifolia Leaf Extract*, Rosa Canina Fruit Extract*, Thymus Vulgaris (Thyme) Leaf Extract*, Dextrin Palmitate, Polyhydroxystearic Acid, Stearalkonium Hectorite, Propylene Carbonate, Synthetic Fluorphlogopite, Tocopherol, Water, Hydrolyzed Sodium Hyaluronate+, Hydroxypropyltrimonium Hyaluronate+, Niacinamide, Sodium Acetylated Hyaluronate+, Butylene Glycol, 1,2-Hexanediol, Pentylene Glycol, Ethylhexylglycerin, Sodium Hyaluronate Crosspolymer+, Limonene++, Citronellol++, Geraniol++, Linalool++, Citral++, Iron Oxides (CI 77491)

*belif original formula

+multi7- Hyaluronic Acid

** Jeju-Haeyun Complex

++ frangrances of botanical origin

For External Use Only.

For external use only.

Questions Or Comments?

Contact our Sun Specialist at 1-866-993-4709 or www.belifusa.com

Keep Out of Reach of Children

Keep out of reach of children.


Structured Label Content

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.
Dosage and Administration (34068-7)

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

Section 51945-4 (51945-4)

Purpose

Sunscreen

Stop Use (Stop use)

Stop use and ask a doctor if rash occurs.

Directions
  • Apply generously and evenly 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • Sun Protection Measure: 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.

*Gently twist the bottom just enough for a single use.

Do Not Use (Do not use)

Do not use on damaged or broken skin

When Using (When using)

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

Other Information

Protect the product in this container from excessive heat and direct sun.

Active Ingredients

Butyl Methoxydibenzolylmethane 2.7%

Ethylhexyl Salicylate 4.5%

Homosalate 9.5%

Octocrylene 5.0%

Inactive Ingredients

Octyldodecanol, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Dicaprylyl Carbonate, Propylheptyl Caprylate, Dibutyl Lauroyl Glutamide, Butyloctyl Salicylate, Dibutyl Ethylhexanoyl Glutamide, Pelargonium Graveolens Flower Oil++, Citrus Aurantium Dulcis (Orange) Peel Oil++, Hyaluronic Acid+, Hydrolyzed Hyaluronic Acid+, Sodium Hyaluronate+, Melissa Officinalis Flower/Leaf/Stem Water*, Rosmarinus Officinalis (Rosemary) Leaf Water*, Eucalyptus Globulus Leaf Extract*, Laminaria Japonica Extract**, Ecklonia Cava Extract**, Hizikia Fusiforme Extract**, Mentha Rotundifolia Leaf Extract*, Rosa Canina Fruit Extract*, Thymus Vulgaris (Thyme) Leaf Extract*, Dextrin Palmitate, Polyhydroxystearic Acid, Stearalkonium Hectorite, Propylene Carbonate, Synthetic Fluorphlogopite, Tocopherol, Water, Hydrolyzed Sodium Hyaluronate+, Hydroxypropyltrimonium Hyaluronate+, Niacinamide, Sodium Acetylated Hyaluronate+, Butylene Glycol, 1,2-Hexanediol, Pentylene Glycol, Ethylhexylglycerin, Sodium Hyaluronate Crosspolymer+, Limonene++, Citronellol++, Geraniol++, Linalool++, Citral++, Iron Oxides (CI 77491)

*belif original formula

+multi7- Hyaluronic Acid

** Jeju-Haeyun Complex

++ frangrances of botanical origin

For External Use Only. (For external use only.)

For external use only.

Questions Or Comments? (Questions or comments?)

Contact our Sun Specialist at 1-866-993-4709 or www.belifusa.com

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)