SPL v2
SPL
SPL Set ID 680f369e-c408-c5c7-e053-2a91aa0a1a6e
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
Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Polymethylsilsesquioxane (4.5 Microns) Tocopherol Sodium Lauroyl Lactylate Phenoxyethanol Ceramide Ap Ethylhexylglycerin Boron Nitride Ceramide Np Phytosphingosine Cholesterol Xanthan Gum Carbomer 940 Ceramide 1 .alpha.-tocopherol Acetate Palmitoyl Proline Phenyl Trimethicone Adenosine Magnesium Palmitoyl Glutamate Palmitic Acid Cyclomethicone 6 Butylene Glycol Dicaprylate/dicaprate Mica Triethoxycaprylylsilane Sodium Palmitoyl Sarcosinate Dipentaerythrityl Hexa C5-9 Acid Esters Dimethicone Butylene Glycol Sodium Chloride Water Glycerin Dimethiconol (100000 Cst) Dimethicone/vinyl Dimethicone Crosspolymer (hard Particle) Zinc Stearate Disteardimonium Hectorite Sorbitan Sesquioleate Aluminum Hydroxide Distearyldimonium 1,2-hexanediol Triethylhexanoin Hyaluronic Acid Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Niacinamide Tromethamine Stearic Acid Peg-30 Dipolyhydroxystearate Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Dipropylene Glycol Sodium Citrate

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
Thefaceshop

Other Information

Protect this product from excessive heat and direct sun

Active Ingredients

Ensulizole 2.7%

Titanium Dioxide 5.46%

Inactive Ingredients

WATER, CYCLOPENTASILOXANE, PHENYL TRIMETHICONE, TRIETHYLHEXANOIN, CYCLOHEXASILOXANE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, DIPENTAERYTHRITYL HEXA C5-9 ACID ESTERS, CETYL PEG/PPG-10/1 DIMETHICONE, NIACINAMIDE, BUTYLENE GLYCOL, TROMETHAMINE, DIMETHICONE, 1,2-HEXANEDIOL, SORBITAN SESQUIOLEATE, PEG-30 DIPOLYHYDROXYSTEARATE, ZINC STEARATE, STEARIC ACID, SODIUM CHLORIDE, DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER, GLYCERIN, DISTEARDIMONIUM HECTORITE, ALUMINUM HYDROXIDE, DISTEARYLDIMONIUM CHLORIDE, HYALURONIC ACID, DIMETHICONOL, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, DIMETHICONE CROSSPOLYMER, LAURYL DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER, PALMITOYL PROLINE, POLYMETHYLSILSESQUIOXANE, ADENOSINE, TRIETHOXYCAPRYLYLSILANE, SODIUM PALMITOYL SARCOSINATE, MAGNESIUM PALMITOYL GLUTAMATE, PALMITIC ACID, DIPROPYLENE GLYCOL, BORON NITRIDE, SODIUM CITRATE, TOCOPHEROL, SODIUM LAUROYL LACTYLATE, CERAMIDE NP, PHENOXYETHANOL, PHYTOSPHINGOSINE, CHOLESTEROL, CERAMIDE AP, ETHYLHEXYLGLYCERIN, XANTHAN GUM, CARBOMER, CERAMIDE EOP, FRAGRANCE, TITANIUM DIOXIDE(CI 77891), MICA, 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
Thefaceshop (THEFACESHOP)

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)

WATER, CYCLOPENTASILOXANE, PHENYL TRIMETHICONE, TRIETHYLHEXANOIN, CYCLOHEXASILOXANE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, DIPENTAERYTHRITYL HEXA C5-9 ACID ESTERS, CETYL PEG/PPG-10/1 DIMETHICONE, NIACINAMIDE, BUTYLENE GLYCOL, TROMETHAMINE, DIMETHICONE, 1,2-HEXANEDIOL, SORBITAN SESQUIOLEATE, PEG-30 DIPOLYHYDROXYSTEARATE, ZINC STEARATE, STEARIC ACID, SODIUM CHLORIDE, DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER, GLYCERIN, DISTEARDIMONIUM HECTORITE, ALUMINUM HYDROXIDE, DISTEARYLDIMONIUM CHLORIDE, HYALURONIC ACID, DIMETHICONOL, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, DIMETHICONE CROSSPOLYMER, LAURYL DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER, PALMITOYL PROLINE, POLYMETHYLSILSESQUIOXANE, ADENOSINE, TRIETHOXYCAPRYLYLSILANE, SODIUM PALMITOYL SARCOSINATE, MAGNESIUM PALMITOYL GLUTAMATE, PALMITIC ACID, DIPROPYLENE GLYCOL, BORON NITRIDE, SODIUM CITRATE, TOCOPHEROL, SODIUM LAUROYL LACTYLATE, CERAMIDE NP, PHENOXYETHANOL, PHYTOSPHINGOSINE, CHOLESTEROL, CERAMIDE AP, ETHYLHEXYLGLYCERIN, XANTHAN GUM, CARBOMER, CERAMIDE EOP, FRAGRANCE, TITANIUM DIOXIDE(CI 77891), MICA, 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: 2026-02-15T11:59:22.273260 · Updated: 2026-03-14T22:59:17.868516