SPL v2
SPL
SPL Set ID 2b4c363b-f767-7901-e063-6394a90adba5
Route
TOPICAL
Published
Effective Date 2025-04-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (17.46 g)
Inactive Ingredients
Ceramide Ns Phytosphingosine Acetyl Hexapeptide-8 Pentylene Glycol Niacinamide Hyaluronic Acid Cetearyl Alcohol Sodium Citrate Butylene Glycol Thymus Vulgaris (thyme) Leaf Dimethicone/phenyl Vinyl Dimethicone Crosspolymer Citral Disteardimonium Hectorite 1,2-hexanediol Isostearic Acid Nutmeg Rosmarinus Officinalis (rosemary) Leaf Oil Cholesterol Eucalyptus Globulus Leaf Ecklonia Cava Limonene, (+)- Benzotriazolyl Dodecyl P-cresol Dipropylene Glycol Caprylyl Glycol Ethylhexylglycerin Caprylyl Methicone Butyloctyl Salicylate Dehydrated Alcohol Dimethicone Polyglyceryl-6 Polyricinoleate Magnesium Sulfate Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Triethoxycaprylylsilane Caprylic/capric Triglyceride Dimethicone/polyglycerin-3 Crosspolymer Tocopherol Rosa Canina Fruit Ceramide Np Ceramide Ap Distearyldimonium Chloride Sodium Acetylated Hyaluronate Sodium Hyaluronate Panthenol Laminaria Japonica Citronellol Geraniol Linalool Water Diphenylsiloxy Phenyl Trimethicone Melissa Officinalis Flowering Top Mentha X Rotundifolia Leaf Glycerin Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Stearic Acid Sargassum Fusiforme

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-11
Description

Zinc Oxide 17.46%

Purpose

Sunscreen

Medication Information

Warnings and Precautions

For external use only.

Purpose

Sunscreen

Dosage and Administration

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

Description

Zinc Oxide 17.46%

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 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 50567-7

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

Section 50570-1

Do not use on damaged or broken skin.

Section 51945-4

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 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.
Active Ingredient

Zinc Oxide 17.46%

Other Information

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

Inactive Ingredients

Water, Dimethicone, Caprylyl Methicone, Butyloctyl Salicylate, Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Dipropylene Glycol, Benzotriazolyl Dodecyl P-Cresol, Glycerin, Niacinamide, Polyglyceryl-6 Polyricinoleate, Disteardimonium Hectorite, 1,2-Hexanediol, Isostearic Acid, Magnesium Sulfate, Methyl Methacrylate Crosspolymer, Panthenol, Trimethylsiloxysilicate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Diphenylsiloxy Phenyl Trimethicone, Triethoxycaprylylsilane, Caprylic/Capric Triglyceride, Dimethicone/Polyglycerin-3 Crosspolymer, Fragrance++, Distearyldimonium Chloride, Dimethicone/Phenyl Vinyl Dimethicone Crosspolymer, Myristica Fragrans (Nutmeg) Extract, Melissa O­cinalis Flower/Leaf/Stem Water*, Rosmarinus O­cinalis (Rosemary) Leaf Water*, Sodium Hyaluronate+, Sodium Citrate, Butylene Glycol, Tocopherol, Cholesterol, Eucalyptus Globulus Leaf Extract*, Hydrolyzed Hyaluronic Acid+, Hydrogenated Lecithin, Alcohol Denat., Mentha Rotundifolia Leaf Extract*, Rosa Canina Fruit Extract*, Hyaluronic Acid+, Hydrolyzed Sodium Hyaluronate+, Hydroxypropyltrimonium Hyaluronate+, Sodium Acetylated Hyaluronate+, Cetearyl Alcohol, Stearic Acid, Thymus Vulgaris (Thyme) Leaf Extract*, Pentylene Glycol, Ceramide NP, Caprylyl Glycol, Ecklonia Cava Extract**, Hizikia Fusiforme Extract**, Laminaria Japonica Extract**, Ethylhexylglycerin, Ceramide NS, Phytosphingosine, Sodium Hyaluronate Crosspolymer+, Acetyl Hexapeptide-8, Ceramide AP, Ceramide AS, Desamido Collagen, Ceramide EOP, Limonene, Citronellol, Geraniol, Linalool, Citral.

(* belif original formula / + multi7-Hyaluron / ** Jeju-Haeyun Complex / ++ : Fragrance of botanical origin)

Questions Or Comments?

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

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.

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 51945-4 (51945-4)

Purpose

Sunscreen

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 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.
Active Ingredient

Zinc Oxide 17.46%

Other Information

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

Inactive Ingredients

Water, Dimethicone, Caprylyl Methicone, Butyloctyl Salicylate, Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Dipropylene Glycol, Benzotriazolyl Dodecyl P-Cresol, Glycerin, Niacinamide, Polyglyceryl-6 Polyricinoleate, Disteardimonium Hectorite, 1,2-Hexanediol, Isostearic Acid, Magnesium Sulfate, Methyl Methacrylate Crosspolymer, Panthenol, Trimethylsiloxysilicate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Diphenylsiloxy Phenyl Trimethicone, Triethoxycaprylylsilane, Caprylic/Capric Triglyceride, Dimethicone/Polyglycerin-3 Crosspolymer, Fragrance++, Distearyldimonium Chloride, Dimethicone/Phenyl Vinyl Dimethicone Crosspolymer, Myristica Fragrans (Nutmeg) Extract, Melissa O­cinalis Flower/Leaf/Stem Water*, Rosmarinus O­cinalis (Rosemary) Leaf Water*, Sodium Hyaluronate+, Sodium Citrate, Butylene Glycol, Tocopherol, Cholesterol, Eucalyptus Globulus Leaf Extract*, Hydrolyzed Hyaluronic Acid+, Hydrogenated Lecithin, Alcohol Denat., Mentha Rotundifolia Leaf Extract*, Rosa Canina Fruit Extract*, Hyaluronic Acid+, Hydrolyzed Sodium Hyaluronate+, Hydroxypropyltrimonium Hyaluronate+, Sodium Acetylated Hyaluronate+, Cetearyl Alcohol, Stearic Acid, Thymus Vulgaris (Thyme) Leaf Extract*, Pentylene Glycol, Ceramide NP, Caprylyl Glycol, Ecklonia Cava Extract**, Hizikia Fusiforme Extract**, Laminaria Japonica Extract**, Ethylhexylglycerin, Ceramide NS, Phytosphingosine, Sodium Hyaluronate Crosspolymer+, Acetyl Hexapeptide-8, Ceramide AP, Ceramide AS, Desamido Collagen, Ceramide EOP, Limonene, Citronellol, Geraniol, Linalool, Citral.

(* belif original formula / + multi7-Hyaluron / ** Jeju-Haeyun Complex / ++ : Fragrance of botanical origin)

Questions Or Comments? (Questions or comments?)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:53.000498 · Updated: 2026-03-14T23:08:17.487612