SPL v5
SPL
SPL Set ID 2a14c11d-2c04-3267-e054-00144ff88e88
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
Dipropylene Glycol Magnesium Palmitoyl Glutamate Phenoxyethanol Aluminum Hydroxide Water Adenosine Sodium Palmitoyl Sarcosinate Triethoxycaprylylsilane Palmitic Acid Hexyl Laurate Polyglyceryl-4 Isostearate Albizia Julibrissin Bark Niacinamide Biosaccharide Gum-1 Butylene Glycol Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Mica Peg-10 Dimethicone (600 Cst) Poly(methyl Methacrylate; 450000 Mw) Tromethamine 1,2-hexanediol Palmitoyl Proline Cyclomethicone 5 Methyl Trimethicone Disteardimonium Hectorite Stearic Acid Sorbitan Sesquioleate Zinc Stearate Distearyldimonium Chloride Alpha-tocopherol Acetate Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Sodium Chloride

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

OHUI Powdery Metal Cushion Compact

Sunscreen Broad Spectrum SPF 50

02 Natural Beige

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 (PRINCIPAL DISPLAY PANEL)

OHUI Powdery Metal Cushion Compact

Sunscreen Broad Spectrum SPF 50

02 Natural Beige

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


Advanced Ingredient Data


Raw Label Data

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