SPL v2
SPL
SPL Set ID 67be9830-c8b3-46cf-e053-2a91aa0a6b71
Route
TOPICAL
Published
Effective Date 2018-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (0.819 g) Ensulizole (0.405 g)
Inactive Ingredients
Biosaccharide Gum-1 Silicon Dioxide Mica Triethoxycaprylylsilane Sodium Palmitoyl Sarcosinate Palmitic Acid Calcium Carbonate Albizia Julibrissin Bark Butylene Glycol Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Methyl Methacrylate Dimethicone/vinyl Dimethicone Crosspolymer (hard Particle) Zinc Stearate Disteardimonium Hectorite Sodium Chloride Sorbitan Sesquioleate Aluminum Hydroxide Distearyldimonium Triethylhexanoin Peg-10 Dimethicone (600 Cst) Dipropylene Glycol Niacinamide Tromethamine 1,2-hexanediol Stearic Acid Sorbitan Sesquiisostearate .alpha.-tocopherol Acetate Palmitoyl Proline Tangerine Peel Adenosine Magnesium Palmitoyl Glutamate Phenoxyethanol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-01-01
Description

Ensulizole 2.7% Titanium Dioxide 5.46%

Purpose

SUNSCREEN

Medication Information

Purpose

SUNSCREEN

Description

Ensulizole 2.7% Titanium Dioxide 5.46%

Uses
  • Helps prevent sunbrun
  • 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. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask 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

Warnings

For external use only

Directions
  • Apply liberally 15 minutes before sun exposure and as needed.
  • Reapply as needed or after towel drying, 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. to 2 p.m.

- Wear long-sleeved shirts, pants, hats, and sunglasses

  • Children under 6 months: Ask a doctor
Other Information

Protect this product from excessive heat and direct sun

Active Ingredients

Ensulizole 2.7%

Titanium Dioxide 5.46%

Inactive Ingredients

CYCLOPENTASILOXANE, WATER, TRIETHYLHEXANOIN, PEG-10 DIMETHICONE, POLYMETHYL METHACRYLATE, NIACINAMIDE, DIPROPYLENE GLYCOL, TROMETHAMINE, 1,2-HEXANEDIOL, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, ZINC STEARATE, DISTEARDIMONIUM HECTORITE, SODIUM CHLORIDE, STEARIC ACID, SORBITAN SESQUIISOSTEARATE, SORBITAN SESQUIOLEATE, ALUMINUM HYDROXIDE, DISTEARYLDIMONIUM CHLORIDE, TOCOPHERYL ACETATE, PALMITOYL PROLINE, CITRUS UNSHIU PEEL EXTRACT, BUTYLENE GLYCOL, ADENOSINE, TRIETHOXYCAPRYLYLSILANE, MAGNESIUM PALMITOYL GLUTAMATE, SODIUM PALMITOYL SARCOSINATE, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, PHENOXYETHANOL, PALMITIC ACID, BIOSACCHARIDE GUM-1, CALCIUM CARBONATE, SILICA, ALBIZIA JULIBRISSIN BARK EXTRACT, FRAGRANCE, TITANIUM DIOXIDE(CI 77891), MICA(CI 77019), IRON OXIDES(CI 77491, CI 77492, CI 77499)

Questions Or Comments?

Call toll free 1-888-498-9004

Principal Display Panel

Structured Label Content

Uses (USES)
  • Helps prevent sunbrun
  • 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 (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 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

Purpose (PURPOSE)

SUNSCREEN

Warnings (WARNINGS)

For external use only

Directions (DIRECTIONS)
  • Apply liberally 15 minutes before sun exposure and as needed.
  • Reapply as needed or after towel drying, 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. to 2 p.m.

- Wear long-sleeved shirts, pants, hats, and sunglasses

  • Children under 6 months: Ask a doctor
Other Information (OTHER INFORMATION)

Protect this product from excessive heat and direct sun

Active Ingredients (ACTIVE INGREDIENTS)

Ensulizole 2.7%

Titanium Dioxide 5.46%

Inactive Ingredients (INACTIVE INGREDIENTS)

CYCLOPENTASILOXANE, WATER, TRIETHYLHEXANOIN, PEG-10 DIMETHICONE, POLYMETHYL METHACRYLATE, NIACINAMIDE, DIPROPYLENE GLYCOL, TROMETHAMINE, 1,2-HEXANEDIOL, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, ZINC STEARATE, DISTEARDIMONIUM HECTORITE, SODIUM CHLORIDE, STEARIC ACID, SORBITAN SESQUIISOSTEARATE, SORBITAN SESQUIOLEATE, ALUMINUM HYDROXIDE, DISTEARYLDIMONIUM CHLORIDE, TOCOPHERYL ACETATE, PALMITOYL PROLINE, CITRUS UNSHIU PEEL EXTRACT, BUTYLENE GLYCOL, ADENOSINE, TRIETHOXYCAPRYLYLSILANE, MAGNESIUM PALMITOYL GLUTAMATE, SODIUM PALMITOYL SARCOSINATE, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, PHENOXYETHANOL, PALMITIC ACID, BIOSACCHARIDE GUM-1, CALCIUM CARBONATE, SILICA, ALBIZIA JULIBRISSIN BARK EXTRACT, FRAGRANCE, TITANIUM DIOXIDE(CI 77891), MICA(CI 77019), IRON OXIDES(CI 77491, CI 77492, CI 77499)

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Call toll free 1-888-498-9004

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:22.270542 · Updated: 2026-03-14T22:59:17.868516