Sei Bella Daily Uv Defense

Sei Bella Daily Uv Defense
SPL v2
SPL
SPL Set ID 1f1d1575-cf37-5d66-e063-6394a90ab2a3
Route
TOPICAL
Published
Effective Date 2024-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (0.225 g) Zinc Oxide (0.236 g) Homosalate (0.188 g) Octisalate (0.094 g) Titanium Dioxide (0.05 g)
Inactive Ingredients
Silicon Dioxide Apple Polymethylsilsesquioxane (4.5 Microns) Propanediol Gossypium Hirsutum Root Sodium Citrate Allantoin Water Caprylyl Trisiloxane Phenoxyethanol Medium-chain Triglycerides Cyclomethicone 5 Alkyl (c12-15) Benzoate Tocopherol Glycerin Coco-caprylate/caprate Dimethicone 2-ethylhexyl Acrylate, Methacrylate, Methyl Methacrylate, Or Butyl Methacrylate/hydroxypropyl Dimethicone Copolymer (30000-300000 Mw) Dimethicone/peg-10/15 Crosspolymer Sodium Chloride Triethoxycaprylylsilane Ethylhexylglycerin Disteardimonium Hectorite 2,3-butanediol Polyhydroxystearic Acid (2300 Mw) Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone Peg-12 Dimethicone/ppg-20 Crosspolymer

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-01
Description

Homosalate 7.5% Octocrylene 9% Octisalate 3.75% Titanium Dioxide 2% Zinc Oxide 9.45%

Medication Information

Indications and Usage

helps prevent sunburn

if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer caused by the sun

Dosage and Administration

Directions For sunscreen use:

  • apply liberally 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:

limiting time in the sun, especially from 10 a.m. - 2 p.m.

wearing long-sleeve shirts, pants, hats, and sunglasses

  • children under 6 months of age: Ask a doctor
Description

Homosalate 7.5% Octocrylene 9% Octisalate 3.75% Titanium Dioxide 2% Zinc Oxide 9.45%

Section 44425-7

store at room temperature 68-77 F. Protect from freezing.

Section 50565-1

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

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 51727-6

water, caprylyl methicone, cyclopentasiloxane, glycerin, caprylic/capric triglyceride, coco-caprylate/caprate, propanediol, pyrus malus (apple) fruit extract, dimethicone, polymethylsilsesquioxane, lauryl peg-9 polydimethylsiloxyethyl dimethicone, PEG-12 dimethicone/PPG-20 crosspolymer, acrylates/dimethicone copolymer, C12-15 alkyl benzoate, polyhydroxystearic acid, dimethicone/peg-10/15 crosspolymer, gossypium hirsutum (cotton) extract, sodium chloride, phenoxyethanol, triethoxycaprylylsilane, ethylhexylglycerin,disteardimonium hectorite, silica, allantoin, sodium citrate, 2,3-butanediol, tocopherol

Section 51945-4

Section 55105-1

sunscreen

Warnings

For external use only. Do not use on damaged or broken skin

Active Ingredients

Homosalate 7.5%

Octocrylene 9%

Octisalate 3.75%

Titanium Dioxide 2%

Zinc Oxide 9.45%

Structured Label Content

Indications and Usage (34067-9)

helps prevent sunburn

if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer caused by the sun

Dosage and Administration (34068-7)

Directions For sunscreen use:

  • apply liberally 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:

limiting time in the sun, especially from 10 a.m. - 2 p.m.

wearing long-sleeve shirts, pants, hats, and sunglasses

  • children under 6 months of age: Ask a doctor
Section 44425-7 (44425-7)

store at room temperature 68-77 F. Protect from freezing.

Section 50565-1 (50565-1)

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

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 51727-6 (51727-6)

water, caprylyl methicone, cyclopentasiloxane, glycerin, caprylic/capric triglyceride, coco-caprylate/caprate, propanediol, pyrus malus (apple) fruit extract, dimethicone, polymethylsilsesquioxane, lauryl peg-9 polydimethylsiloxyethyl dimethicone, PEG-12 dimethicone/PPG-20 crosspolymer, acrylates/dimethicone copolymer, C12-15 alkyl benzoate, polyhydroxystearic acid, dimethicone/peg-10/15 crosspolymer, gossypium hirsutum (cotton) extract, sodium chloride, phenoxyethanol, triethoxycaprylylsilane, ethylhexylglycerin,disteardimonium hectorite, silica, allantoin, sodium citrate, 2,3-butanediol, tocopherol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

sunscreen

Warnings

For external use only. Do not use on damaged or broken skin

Active Ingredients

Homosalate 7.5%

Octocrylene 9%

Octisalate 3.75%

Titanium Dioxide 2%

Zinc Oxide 9.45%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:59.567213 · Updated: 2026-03-14T23:12:05.275634