SPL v2
SPL
SPL Set ID 52ef4cfc-f116-0dbb-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2017-01-01
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
Disteardimonium Hectorite Sodium Chloride Water Dipropylene Glycol Niacinamide Tromethamine 1,2-hexanediol Stearic Acid Aluminum Hydroxide Sorbitan Sesquioleate Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Biosaccharide Gum-1 Phenyl Trimethicone Sodium Citrate Sodium Palmitoyl Sarcosinate Palmitoyl Proline Peg-30 Dipolyhydroxystearate Magnesium Palmitoyl Glutamate Distearyldimonium Chloride Palmitic Acid Tocopherol Triethoxycaprylylsilane Triethylhexanoin Zinc Stearate Phenoxyethanol Polyglyceryl-4 Isostearate Luffa Aegyptiaca Fruit Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Hexyl Laurate Butylene Glycol Dicaprylate/dicaprate Adenosine Cyclomethicone 5 Dimethicone Dipentaerythrityl Hexa C5-9 Acid Esters

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-01-01

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 sunburn.
  • If used as directed with other sun protection measures (see Directions), may decrease the risk of skin cancer and early skin aging caused by the sun.
Warnings

For external use only

Do not use on damaged or broken skin.

When using this product: Keep out of the eyes. Rinse with water to remove.

Stop use and ask doctor, if rash occurs.

Keep out of reach of children. If product is swallowed, get medical help or

contact a Posion Control Center right away.

Directions
  • Apply liberally 15 minutes before sun exposure.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • 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 othersun protection measures including:

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

- Wear longsleeved shirts, pants, hats, and sunglasses.

  • Children under 6 months: Ask a doctor.
Other Information
  • Protect the product in this container from excessive heat and direct sun.
Active Ingredients

ENSULIZOLE 2.7%, TITANIUM DIOXIDE 5.46%

Inactive Ingredients

WATER, TRIETHYLHEXANOIN, DIMETHICONE, PHENYL TRIMETHICONE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, CYCLOPENTASILOXANE, DIPENTAERYTHRITYL HEXA C5-9 ACID ESTERS, CETYL PEG/PPG-10/1 DIMETHICONE, NIACINAMIDE, TROMETHAMINE, 1,2-HEXANEDIOL, SORBITAN SESQUIOLEATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, PEG-30 DIPOLYHYDROXYSTEARATE, SODIUM CHLORIDE, ZINC STEARATE, DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER, DISTEARDIMONIUM HECTORITE, ALUMINUM HYDROXIDE, STEARIC ACID, DISTEARYLDIMONIUM CHLORIDE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, TRIETHOXYSILYLETHYL, POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, PALMITOYL PROLINE, ADENOSINE, BIOSACCHARIDE GUM-1, TRIETHOXYCAPRYLYLSILANE, MAGNESIUM PALMITOYL GLUTAMATE, SODIUM PALMITOYL SARCOSINATE, PALMITIC ACID, DIPROPYLENE GLYCOL, LUFFA CYLINDRICA FRUIT EXTRACT, HEXYL LAURATE, POLYGLYCERYL-4 ISOSTEARATE, SODIUM CITRATE, TOCOPHEROL, FRAGRANCE*, TITANIUM DIOXIDE(CI 77891), MICA, IRON OXIDES(CI 77492), IRON OXIDES(CI 77491), IRON OXIDES(CI 77499)

Principal Display Panel 30 G (15 G X 2) Natural Beige

Moisturizing bomb cushion compact - natural beige

Provides moisture & coverage for up to 26 hrs.*

Dermatologically tested

Sunscreen Broad Spectrum SPF 50

Net Wt. 1.04 oz / 30 g (15g x 2)


Structured Label Content

Uses (USES)
  • Helps prevent sunburn.
  • If used as directed with other sun protection measures (see Directions), may decrease the risk of skin cancer and early skin aging caused by the sun.
Purpose (PURPOSE)

Sunscreen

Warnings (WARNINGS)

For external use only

Do not use on damaged or broken skin.

When using this product: Keep out of the eyes. Rinse with water to remove.

Stop use and ask doctor, if rash occurs.

Keep out of reach of children. If product is swallowed, get medical help or

contact a Posion Control Center right away.

Directions (DIRECTIONS)
  • Apply liberally 15 minutes before sun exposure.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • 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 othersun protection measures including:

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

- Wear longsleeved shirts, pants, hats, and sunglasses.

  • Children under 6 months: Ask a doctor.
Other Information (OTHER INFORMATION)
  • Protect the product in this container from excessive heat and direct sun.
Active Ingredients (ACTIVE INGREDIENTS)

ENSULIZOLE 2.7%, TITANIUM DIOXIDE 5.46%

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER, TRIETHYLHEXANOIN, DIMETHICONE, PHENYL TRIMETHICONE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, CYCLOPENTASILOXANE, DIPENTAERYTHRITYL HEXA C5-9 ACID ESTERS, CETYL PEG/PPG-10/1 DIMETHICONE, NIACINAMIDE, TROMETHAMINE, 1,2-HEXANEDIOL, SORBITAN SESQUIOLEATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, PEG-30 DIPOLYHYDROXYSTEARATE, SODIUM CHLORIDE, ZINC STEARATE, DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER, DISTEARDIMONIUM HECTORITE, ALUMINUM HYDROXIDE, STEARIC ACID, DISTEARYLDIMONIUM CHLORIDE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, TRIETHOXYSILYLETHYL, POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, PALMITOYL PROLINE, ADENOSINE, BIOSACCHARIDE GUM-1, TRIETHOXYCAPRYLYLSILANE, MAGNESIUM PALMITOYL GLUTAMATE, SODIUM PALMITOYL SARCOSINATE, PALMITIC ACID, DIPROPYLENE GLYCOL, LUFFA CYLINDRICA FRUIT EXTRACT, HEXYL LAURATE, POLYGLYCERYL-4 ISOSTEARATE, SODIUM CITRATE, TOCOPHEROL, FRAGRANCE*, TITANIUM DIOXIDE(CI 77891), MICA, IRON OXIDES(CI 77492), IRON OXIDES(CI 77491), IRON OXIDES(CI 77499)

Principal Display Panel 30 G (15 G X 2) Natural Beige (PRINCIPAL DISPLAY PANEL - 30 g (15 g x 2) Natural Beige)

Moisturizing bomb cushion compact - natural beige

Provides moisture & coverage for up to 26 hrs.*

Dermatologically tested

Sunscreen Broad Spectrum SPF 50

Net Wt. 1.04 oz / 30 g (15g x 2)


Advanced Ingredient Data


Raw Label Data

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