53208-600-03 Ohui Ultimate Cover Cc Cushion Compact 01 Light Beige

53208-600-03 Ohui Ultimate Cover Cc Cushion Compact 01 Light Beige
SPL v2
SPL
SPL Set ID d2f9c54b-ac4e-5141-e053-2a95a90aa2b8
Route
TOPICAL
Published
Effective Date 2016-01-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ensulizole (0.405 g) Titanium Dioxide (0.819 g)
Inactive Ingredients
Tocopherol Niacinamide Water Triethylhexanoin Dimethicone Phenyl Trimethicone Butylene Glycol Dicaprylate/dicaprate Dipentaerythrityl Hexa C5-9 Acid Esters Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Sorbitan Sesquioleate Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Hexyl Laurate Sodium Citrate Zinc Stearate Peg-30 Dipolyhydroxystearate Adenosine Sodium Palmitoyl Sarcosinate 1,2-hexanediol Sodium Chloride Aluminum Hydroxide Stearic Acid Distearyldimonium Chloride Triethoxycaprylylsilane Dipropylene Glycol Luffa Aegyptiaca Fruit Polyglyceryl-4 Isostearate Phenoxyethanol Magnesium Palmitoyl Glutamate Palmitic Acid Cyclomethicone 5 Tromethamine Palmitoyl Proline Biosaccharide Gum-1 Disteardimonium Hectorite

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-01-25

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), decreases the risk of skin cancer and early skin aging caused by the sun exposure.

Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

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 a doctor, if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison 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, regulary 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.

Other Information

Protect this product 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, SODIUM CHLORIDE, ZINC STEARATE, PEG-30 DIPOLYHYDROXYSTEARATE, DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER, DISTEARDIMONIUM HECTORITE, ALUMINUM HYDROXIDE, STEARIC ACID, DISTEARYLDIMONIUM CHLORIDE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, PALMITOYL PROLINE, PHENOXY ETHANOL, ADENOSINE, BIOSACCHARIDE GUM-1, TRIETHOXYCAPRYLYLSILANE, MAGNESIUM PALMITOYL GLUTAMATE, SODIUM PALMITOYL SARCOSINATE, PALMITIC ACID, DIPROPYLENE GLYCOL, LUFFA CYLINDRICA FRUIT EXTRACT, HEXYL LAURATE, SODIUM CITRATE, POLYGLYCERYL-4 ISOSTEARATE, TOCOPHEROL, FRAGRANCE, TITANIUM DIOXIDE(CI 77891), MICA, IRON OXIDES(CI 77492), IRON OXIDES(CI 77491), IRON OXIDES(CI 77499)

Principal Display Panel

O HUI

ULTIMATE COVER

CC CUSHION COMPACT

Sunscreen

Broad Spectrum SPF 50

Net Wt. 1.58 oz / 45 g (15g x 3)


Structured Label Content

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 exposure.

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.

Purpose

Sunscreen

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 a doctor, if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison 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, regulary 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.

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, 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, SODIUM CHLORIDE, ZINC STEARATE, PEG-30 DIPOLYHYDROXYSTEARATE, DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER, DISTEARDIMONIUM HECTORITE, ALUMINUM HYDROXIDE, STEARIC ACID, DISTEARYLDIMONIUM CHLORIDE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, PALMITOYL PROLINE, PHENOXY ETHANOL, ADENOSINE, BIOSACCHARIDE GUM-1, TRIETHOXYCAPRYLYLSILANE, MAGNESIUM PALMITOYL GLUTAMATE, SODIUM PALMITOYL SARCOSINATE, PALMITIC ACID, DIPROPYLENE GLYCOL, LUFFA CYLINDRICA FRUIT EXTRACT, HEXYL LAURATE, SODIUM CITRATE, POLYGLYCERYL-4 ISOSTEARATE, TOCOPHEROL, FRAGRANCE, TITANIUM DIOXIDE(CI 77891), MICA, IRON OXIDES(CI 77492), IRON OXIDES(CI 77491), IRON OXIDES(CI 77499)

Principal Display Panel

O HUI

ULTIMATE COVER

CC CUSHION COMPACT

Sunscreen

Broad Spectrum SPF 50

Net Wt. 1.58 oz / 45 g (15g x 3)


Advanced Ingredient Data


Raw Label Data

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