SPL v2
SPL
SPL Set ID 2ab771d0-25ae-1256-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2016-01-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (1.077 g) Ensulizole (0.405 g) Octinoxate (1.05 g) Zinc Oxide (0.436 g)
Inactive Ingredients
Methyl Trimethicone Peg-10 Dimethicone (600 Cst) Disteardimonium Hectorite Sodium Chloride Cyclomethicone 5 Water Dipropylene Glycol Niacinamide Tromethamine 1,2-hexanediol Stearic Acid Aluminum Hydroxide Sorbitan Sesquioleate Poly(methyl Methacrylate; 450000 Mw) Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-01-25
Description

ENSULIZOLE 2.7%, OCTINOXATE 7%, TITANIUM DIOXIDE 7.18%, ZINC OXIDE 2.91%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

ENSULIZOLE 2.7%, OCTINOXATE 7%, TITANIUM DIOXIDE 7.18%, ZINC OXIDE 2.91%

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.

Warnings

For external use only

Do not use on damaged or broken skin.

When using this product: Kepp 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 other

sun 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 this product from excessive heat and direct sun.
Active Ingredients

ENSULIZOLE 2.7%, OCTINOXATE 7%, TITANIUM DIOXIDE 7.18%, ZINC OXIDE 2.91%

Inactive Ingredients

CYCLOPENTASILOXANE, WATER, METHYL TRIMETHICONE, DIPROPYLENE GLYCOL, PEG-10 DIMETHICONE, POLYMETHYL METHACRYLATE, NIACINAMIDE, TROMETHAMINE, 1,2-HEXANEDIOL, DISTEARDIMONIUM HECTORITE, STEARIC ACID, ALUMINUM HYDROXIDE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SODIUM CHLORIDE, SORBITAN SESQUIOLEATE, SORBITAN SESQUIISOSTEARATE, ZINC STEARATE, DISTEARYLDIMONIUM CHLORIDE, TOCOPHERYL ACETATE, PALMITOYL PROLINE, DIMETHICONE/METHICONE COPOLYMER, ADENOSINE, MAGNESIUM PALMITOYL GLUTAMATE, SODIUM PALMITOYL SARCOSINATE, PHENOXYETHANOL, TRIETHOXYCAPRYLYLSILANE, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, BIOSACCHARIDE GUM-1, PALMITIC ACID, BUTYLENE GLYCOL, CETYL PEG/PPG-10/1 DIMETHICONE, HEXYL LAURATE, POLYGLYCERYL-4 ISOSTEARATE, ALBIZIA JULIBRISSIN BARK EXTRACT, FRAGRANCE, TITANIUM DIOXIDE(CI 77891), MICA, IRON OXIDES(CI 77492), IRON OXIDES(CI 77491), IRON OXIDES(CI 77499)

Principal Display Panel 15 G Container 01 Light Beige

OHUI Powdery Metal Cushion Compact

Sunscreen Broad Spectrum SPF 50

Net Wt. 1.05 oz / 30 g (15gx2)

Structured Label Content

Uses (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.

Purpose (PURPOSE)

Sunscreen

Warnings (WARNINGS)

For external use only

Do not use on damaged or broken skin.

When using this product: Kepp 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 other

sun 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 this product from excessive heat and direct sun.
Active Ingredients (ACTIVE INGREDIENTS)

ENSULIZOLE 2.7%, OCTINOXATE 7%, TITANIUM DIOXIDE 7.18%, ZINC OXIDE 2.91%

Inactive Ingredients (INACTIVE INGREDIENTS)

CYCLOPENTASILOXANE, WATER, METHYL TRIMETHICONE, DIPROPYLENE GLYCOL, PEG-10 DIMETHICONE, POLYMETHYL METHACRYLATE, NIACINAMIDE, TROMETHAMINE, 1,2-HEXANEDIOL, DISTEARDIMONIUM HECTORITE, STEARIC ACID, ALUMINUM HYDROXIDE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SODIUM CHLORIDE, SORBITAN SESQUIOLEATE, SORBITAN SESQUIISOSTEARATE, ZINC STEARATE, DISTEARYLDIMONIUM CHLORIDE, TOCOPHERYL ACETATE, PALMITOYL PROLINE, DIMETHICONE/METHICONE COPOLYMER, ADENOSINE, MAGNESIUM PALMITOYL GLUTAMATE, SODIUM PALMITOYL SARCOSINATE, PHENOXYETHANOL, TRIETHOXYCAPRYLYLSILANE, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, BIOSACCHARIDE GUM-1, PALMITIC ACID, BUTYLENE GLYCOL, CETYL PEG/PPG-10/1 DIMETHICONE, HEXYL LAURATE, POLYGLYCERYL-4 ISOSTEARATE, ALBIZIA JULIBRISSIN BARK EXTRACT, FRAGRANCE, TITANIUM DIOXIDE(CI 77891), MICA, IRON OXIDES(CI 77492), IRON OXIDES(CI 77491), IRON OXIDES(CI 77499)

Principal Display Panel 15 G Container 01 Light Beige (PRINCIPAL DISPLAY PANEL - 15 g Container 01 Light Beige)

OHUI Powdery Metal Cushion Compact

Sunscreen Broad Spectrum SPF 50

Net Wt. 1.05 oz / 30 g (15gx2)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:04.333851 · Updated: 2026-03-14T22:54:16.821321