SPL v1
SPL
SPL Set ID 52ff4754-d5ee-3297-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2017-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (2.2 g) Ensulizole (1.75 g) Octinoxate (3.5 g) Octisalate (2.25 g) Zinc Oxide (4.86 g)
Inactive Ingredients
Disteardimonium Hectorite Water Dipropylene Glycol Tromethamine Stearic Acid Aluminum Hydroxide Sorbitan Sesquioleate Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Phenyl Trimethicone Distearyldimonium Chloride Triethoxycaprylylsilane Triethylhexanoin Phenoxyethanol Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone Chrysin Hydrogen Dimethicone (20 Cst) Dimethicone Glycerin Dicaprylyl Carbonate Panthenol Galanthus Nivalis Seed Glyceryl Caprylate Distearyldimonium Ethylhexylglycerin Diphenylsiloxy Phenyl Trimethicone Mica

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-06-01
Description

ENSULIZOLE 3.5%, OCTINOXATE 7.0%, OCTISALATE 4.5%, TITANIUM DIOXIDE 4.4%, ZINC OXIDE 9.71%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

ENSULIZOLE 3.5%, OCTINOXATE 7.0%, OCTISALATE 4.5%, TITANIUM DIOXIDE 4.4%, ZINC OXIDE 9.71%

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 3.5%, OCTINOXATE 7.0%, OCTISALATE 4.5%, TITANIUM DIOXIDE 4.4%, ZINC OXIDE 9.71%

Inactive Ingredients

WATER, CYCLOPENTASILOXANE, DIPROPYLENE GLYCOL, GLYCERIN, DICAPRYLYL CARBONATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TROMETHAMINE, DIMETHICONE, PANTHENOL, CHRYSIN, GALANTHUS NIVALIS SEED EXTRACT, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, DISTEARDIMONIUM HECTORITE, ALUMINUM HYDROXIDE, STEARIC ACID, ZINC STEARATE, SORBITAN SESQUIOLEATE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, GLYCERYL CAPRYLATE, HYDROGEN DIMETHICONE, DISTEARYLDIMONIUM CHLORIDE, ETHYLHEXYLGLYCERIN, TRISODIUM EDTA, TRIETHOXYCAPRYLYLSILANE, DIPHENYLSILOXY PHENYL TRIMETHICONE, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, MICA, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499), FRAGRANCE

Principal Display Panel

O HUI Perfect Sun Black EX

Sunscreen Broad Spectrum SPF 50+

1.69 fl oz / 50 ml

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 3.5%, OCTINOXATE 7.0%, OCTISALATE 4.5%, TITANIUM DIOXIDE 4.4%, ZINC OXIDE 9.71%

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER, CYCLOPENTASILOXANE, DIPROPYLENE GLYCOL, GLYCERIN, DICAPRYLYL CARBONATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TROMETHAMINE, DIMETHICONE, PANTHENOL, CHRYSIN, GALANTHUS NIVALIS SEED EXTRACT, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, DISTEARDIMONIUM HECTORITE, ALUMINUM HYDROXIDE, STEARIC ACID, ZINC STEARATE, SORBITAN SESQUIOLEATE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, GLYCERYL CAPRYLATE, HYDROGEN DIMETHICONE, DISTEARYLDIMONIUM CHLORIDE, ETHYLHEXYLGLYCERIN, TRISODIUM EDTA, TRIETHOXYCAPRYLYLSILANE, DIPHENYLSILOXY PHENYL TRIMETHICONE, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, MICA, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499), FRAGRANCE

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

O HUI Perfect Sun Black EX

Sunscreen Broad Spectrum SPF 50+

1.69 fl oz / 50 ml

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:22.899421 · Updated: 2026-03-14T22:54:47.454101