Elizabeth Arden Prevage City Smart Broad Spectrum Hydrating Shield

Elizabeth Arden Prevage City Smart Broad Spectrum Hydrating Shield
SPL v3
SPL
SPL Set ID b60c9b41-cf32-ee94-e053-2a95a90abab0
Route
TOPICAL
Published
Effective Date 2019-03-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (5.6 mg) Titanium Dioxide (6.2 mg)
Inactive Ingredients
Arabidopsis Thaliana Whole Peg-9 Polydimethylsiloxyethyl Dimethicone Phenoxyethanol Linalool, (+/-)- Dimethicone Alkyl (c12-15) Benzoate Caprylyl Trisiloxane Isomethyl-.alpha.-ionone Ferric Oxide Red Lecithin, Soybean Mica Peg/ppg-18/18 Dimethicone Sodium Pyrrolidone Carboxylate Water Hydrogen Dimethicone (20 Cst) Hydroxydecyl Ubiquinoyl Dipalmitoyl Glycerate Cyclomethicone 5 Pentylene Glycol Butylene Glycol Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Green Tea Leaf Caprylyl Glycol Edetate Disodium Anhydrous Ergothioneine Carnosine Isopropyl Myristate Silica Dimethyl Silylate Ferulic Acid Stannic Oxide .alpha.-tocopherol Acetate Glycerin Aluminum Hydroxide Chlorphenesin Ferric Oxide Yellow Ferrosoferric Oxide Isododecane Stearic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-03-14

Description

TITANIUM DIOXIDE 6.2% W/W.................Sunscreen ZINC OXIDE 5.6% W/W ............................Sunscreen


Medication Information

Indications and Usage
  • Helps prevent sunburn
Dosage and Administration

As needed

Description

TITANIUM DIOXIDE 6.2% W/W.................Sunscreen ZINC OXIDE 5.6% W/W ............................Sunscreen

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

Section 50565-1

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

Section 55105-1

Sunscreen

Warnings

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of 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.

Carton Art

Other Information

■ Protect this product from excessive heat and direct

■ Store at room temperature

Active Ingredients

TITANIUM DIOXIDE 6.2% W/W.................Sunscreen

ZINC OXIDE 5.6% W/W ............................Sunscreen

Inactive Ingredients

CYCLOPENTASILOXANE, WATER/AQUA/EAU, ISODODECANE, DIMETHICONE, C12-15 ALKYL BENZOATE, ISOPROPYL MYRISTATE, PENTYLENE GLYCOL, BUTYLENE GLYCOL, SILICA DIMETHYL SILYLATE, CAPRYLYL METHICONE,

POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, ACRYLATES/POLYTRIMETHYLSILOXYMETHACRYLATE COPOLYMER, GLYCERIN, ALUMINUM HYDROXIDE, STEARIC ACID, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, CARNOSINE, ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, ARABIDOPSIS THALIANA EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, CAPRYLYL GLYCOL, DISODIUM EDTA, ERGOTHIONEINE, FERULIC ACID, HYDROGEN DIMETHICONE, HYDROXYDECYL UBIQUINOYL DIPALMITOYL GLYCERATE, LECITHIN, MICA, MICROCOCCUS LYSATE, PARFUM/FRAGRANCE, PEG/PPG-18/18 DIMETHICONE, PLANKTON EXTRACT, SODIUM PCA, TIN OXIDE, TOCOPHERYL ACETATE, TRIETHOXYCAPRYLYLSILANE, ALPHA-ISOMETHYL IONONE, LINALOOL, CHLORPHENESIN, PHENOXYETHANOL, IRON OXIDES (CI 77491, CI 77492, CI 77499), TITANIUM DIOXIDE (CI 77891).

Directions for Sunscreen Use

Directions For Sunscreen Use:

■ Apply liberally 15 minutes before sun exposure

■ Reapply:

  • at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating

■ 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 of 15 or higher and other sun protection measures including:

■ Limit time in the sun, especially from 10 a.m. – 2 p.m.

■ Wear long-sleeve shirts, pants, hats, and sunglasses

■ Children under 6 months: Ask a doctor


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

Indications and Usage (34067-9)
  • Helps prevent sunburn
Dosage and Administration (34068-7)

As needed

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.

Section 55105-1 (55105-1)

Sunscreen

Warnings (WARNINGS)

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of 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.

Carton Art (CARTON ART)

Other Information (OTHER INFORMATION)

■ Protect this product from excessive heat and direct

■ Store at room temperature

Active Ingredients (ACTIVE INGREDIENTS)

TITANIUM DIOXIDE 6.2% W/W.................Sunscreen

ZINC OXIDE 5.6% W/W ............................Sunscreen

Inactive Ingredients (INACTIVE INGREDIENTS)

CYCLOPENTASILOXANE, WATER/AQUA/EAU, ISODODECANE, DIMETHICONE, C12-15 ALKYL BENZOATE, ISOPROPYL MYRISTATE, PENTYLENE GLYCOL, BUTYLENE GLYCOL, SILICA DIMETHYL SILYLATE, CAPRYLYL METHICONE,

POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, ACRYLATES/POLYTRIMETHYLSILOXYMETHACRYLATE COPOLYMER, GLYCERIN, ALUMINUM HYDROXIDE, STEARIC ACID, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, CARNOSINE, ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, ARABIDOPSIS THALIANA EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, CAPRYLYL GLYCOL, DISODIUM EDTA, ERGOTHIONEINE, FERULIC ACID, HYDROGEN DIMETHICONE, HYDROXYDECYL UBIQUINOYL DIPALMITOYL GLYCERATE, LECITHIN, MICA, MICROCOCCUS LYSATE, PARFUM/FRAGRANCE, PEG/PPG-18/18 DIMETHICONE, PLANKTON EXTRACT, SODIUM PCA, TIN OXIDE, TOCOPHERYL ACETATE, TRIETHOXYCAPRYLYLSILANE, ALPHA-ISOMETHYL IONONE, LINALOOL, CHLORPHENESIN, PHENOXYETHANOL, IRON OXIDES (CI 77491, CI 77492, CI 77499), TITANIUM DIOXIDE (CI 77891).

Directions for Sunscreen Use (DIRECTIONS FOR SUNSCREEN USE)

Directions For Sunscreen Use:

■ Apply liberally 15 minutes before sun exposure

■ Reapply:

  • at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating

■ 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 of 15 or higher and other sun protection measures including:

■ Limit time in the sun, especially from 10 a.m. – 2 p.m.

■ Wear long-sleeve shirts, pants, hats, and sunglasses

■ Children under 6 months: Ask a doctor


Advanced Ingredient Data


Raw Label Data

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