Iope Air Cushion ®

Iope Air Cushion ®
SPL v9
SPL
SPL Set ID 29d6cc8d-1469-479d-a15a-e78d4e22d4a2
Route
TOPICAL
Published
Effective Date 2018-10-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (2.94 g) Octinoxate (2.1 g) Titanium Dioxide (1.245 g)
Inactive Ingredients
Ferric Oxide Red Ethylhexylglycerin Ferrosoferric Oxide Edetate Disodium Anhydrous Adenosine Trehalose Butylene Glycol Poly(methyl Methacrylate; 450000 Mw) Pidolic Acid Lactic Acid, Unspecified Form Dextrose, Unspecified Form Stannic Oxide Glycine Silicon Dioxide Urea Sodium Glycerophosphate Serine Glutamic Acid Potassium Magnesium Aspartate Aspartic Acid Leucine Alanine Lysine Arginine Calcium Gluconate Magnesium Gluconate Tyrosine Phenylalanine Proline Threonine Valine Isoleucine Citric Acid Monohydrate Histidine N-acetylglucosamine Creatine Uric Acid Cysteine Methionine Water Cyclomethicone 5 Butylene Glycol Dicaprylate/dicaprate Cyclomethicone 6 Peg-10 Dimethicone (600 Cst) Propanediol Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone Niacinamide Glycerin Sodium Chloride Aluminum Hydroxide Ferric Oxide Yellow Stearic Acid Dimethicone Triethoxycaprylylsilane Disteardimonium Hectorite Ethylhexyl Palmitate Isostearic Acid Isopropyl Palmitate Caprylyl Glycol Anhydrous Dextrose Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2018-09-20 Until 2021-03-21

Description

Drug Facts


Medication Information

Description

Drug Facts

Use
  • 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 42229-5

Drug Facts

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
ACTIVE INGREDIENTS W/W Purpose
OCTINOXATE 7% Sunscreen
TITANIUM DIOXIDE 4.15% Sunscreen
ZINC OXIDE 9.8% Sunscreen
Warnings

For external use only

Directions
  • 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 value 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-sleeved shirts, pants, hats, and sunglasses.
  • Children under 6 months of age: Ask a doctor.
Do Not Use On
  • damaged or broken skin.
Other Information

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

WATER / AQUA / EAU , CYCLOPENTASILOXANE , BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE , CYCLOHEXASILOXANE , TITANIUM DIOXIDE (CI 77891) , PEG-10 DIMETHICONE , PROPANEDIOL , LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE , NIACINAMIDE , METHYL METHACRYLATE CROSSPOLYMER , GLYCERIN , ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER , POLYHYDROXYSTEARIC ACID , SODIUM CHLORIDE , ALUMINUM HYDROXIDE , IRON OXIDES (CI 77492) , FRAGRANCE / PARFUM , STEARIC ACID , DIMETHICONE , TRIETHOXYCAPRYLYLSILANE , DISTEARDIMONIUM HECTORITE , ISOPROPYL PALMITATE , ISOSTEARIC ACID , LECITHIN , ETHYLHEXYL PALMITATE , CAPRYLYL GLYCOL , IRON OXIDES (CI 77491) , POLYGLYCERYL-3 POLYRICINOLEATE , DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER , ETHYLHEXYLGLYCERIN , ACRYLATES/STEARYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER , RON OXIDES (CI 77499) , TRIMETHYLSILOXYSILICATE , DISODIUM EDTA , ADENOSINE , TREHALOSE , BUTYLENE GLYCOL , SYNTHETIC FLUORPHLOGOPITE , POLYMETHYL METHACRYLATE , LACTIC ACID , PCA , GLUCOSE , TIN OXIDE , GLYCINE , SILICA , SODIUM GLYCEROPHOSPHATE , UREA , SERINE , GLUTAMIC ACID , POTASSIUM MAGNESIUM ASPARTATE , ASPARTIC ACID , LEUCINE , ALANINE , LYSINE , ARGININE , MAGNESIUM GLUCONATE , CALCIUM GLUCONATE , TYROSINE , PHENYLALANINE , THREONINE , VALINE , PROLINE , ISOLEUCINE , CITRIC ACID , HISTIDINE , ACETYL GLUCOSAMINE , CREATINE , URIC ACID , CYSTEINE , METHIONINE , LIPASE , CHITOSAN.

When Using This Product
  • keep out of eyes.
  • rinse with water to remove.
Stop Use and Ask A Doctor If

rash occurs.

Principal Display Panel 15 G Container Carton 13 Ivory

IOPE

AIR CUSHION ® COVER 13 IVORY

BROAD SPECTRUM SPF 50+ SUNSCREEN

Net wt. 1.05 OZ. / 30 g (15 g x 2)

AIR CUSHION ®

Principal Display Panel 15 G Container Carton 23 Beige

IOPE

AIR CUSHION ® COVER 23 BEIGE



BROAD SPECTRUM SPF 50+ SUNSCREEN



Net wt. 1.05 OZ. / 30 g (15 g x 2)

AIR CUSHION ®

Principal Display Panel 15 G Container Carton 21 Vanilla

IOPE

AIR CUSHION ® COVER 21 VANILLA



BROAD SPECTRUM SPF 50+ SUNSCREEN



Net wt. 1.05 OZ. / 30 g (15 g x 2)

AIR CUSHION ®

Principal Display Panel 15 G Container Carton 31 Warm Beige

IOPE

IOPE AIR CUSHION ® COVER 31 WARM BEIGE



BROAD SPECTRUM SPF 50+ SUNSCREEN



Net wt. 1.05 OZ. / 30 g (15 g x 2)

AIR CUSHION ®


Structured Label Content

Use (USE)
  • 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 42229-5 (42229-5)

Drug Facts

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)
ACTIVE INGREDIENTS W/W Purpose
OCTINOXATE 7% Sunscreen
TITANIUM DIOXIDE 4.15% Sunscreen
ZINC OXIDE 9.8% Sunscreen
Warnings (WARNINGS)

For external use only

Directions (DIRECTIONS)
  • 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 value 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-sleeved shirts, pants, hats, and sunglasses.
  • Children under 6 months of age: Ask a doctor.
Do Not Use On (Do not use on)
  • damaged or broken skin.
Other Information (Other information)

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER / AQUA / EAU , CYCLOPENTASILOXANE , BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE , CYCLOHEXASILOXANE , TITANIUM DIOXIDE (CI 77891) , PEG-10 DIMETHICONE , PROPANEDIOL , LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE , NIACINAMIDE , METHYL METHACRYLATE CROSSPOLYMER , GLYCERIN , ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER , POLYHYDROXYSTEARIC ACID , SODIUM CHLORIDE , ALUMINUM HYDROXIDE , IRON OXIDES (CI 77492) , FRAGRANCE / PARFUM , STEARIC ACID , DIMETHICONE , TRIETHOXYCAPRYLYLSILANE , DISTEARDIMONIUM HECTORITE , ISOPROPYL PALMITATE , ISOSTEARIC ACID , LECITHIN , ETHYLHEXYL PALMITATE , CAPRYLYL GLYCOL , IRON OXIDES (CI 77491) , POLYGLYCERYL-3 POLYRICINOLEATE , DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER , ETHYLHEXYLGLYCERIN , ACRYLATES/STEARYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER , RON OXIDES (CI 77499) , TRIMETHYLSILOXYSILICATE , DISODIUM EDTA , ADENOSINE , TREHALOSE , BUTYLENE GLYCOL , SYNTHETIC FLUORPHLOGOPITE , POLYMETHYL METHACRYLATE , LACTIC ACID , PCA , GLUCOSE , TIN OXIDE , GLYCINE , SILICA , SODIUM GLYCEROPHOSPHATE , UREA , SERINE , GLUTAMIC ACID , POTASSIUM MAGNESIUM ASPARTATE , ASPARTIC ACID , LEUCINE , ALANINE , LYSINE , ARGININE , MAGNESIUM GLUCONATE , CALCIUM GLUCONATE , TYROSINE , PHENYLALANINE , THREONINE , VALINE , PROLINE , ISOLEUCINE , CITRIC ACID , HISTIDINE , ACETYL GLUCOSAMINE , CREATINE , URIC ACID , CYSTEINE , METHIONINE , LIPASE , CHITOSAN.

When Using This Product (When using this product)
  • keep out of eyes.
  • rinse with water to remove.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

rash occurs.

Principal Display Panel 15 G Container Carton 13 Ivory (PRINCIPAL DISPLAY PANEL - 15 g Container Carton - 13 Ivory)

IOPE

AIR CUSHION ® COVER 13 IVORY

BROAD SPECTRUM SPF 50+ SUNSCREEN

Net wt. 1.05 OZ. / 30 g (15 g x 2)

AIR CUSHION ®

Principal Display Panel 15 G Container Carton 23 Beige (PRINCIPAL DISPLAY PANEL - 15 g Container Carton - 23 Beige)

IOPE

AIR CUSHION ® COVER 23 BEIGE



BROAD SPECTRUM SPF 50+ SUNSCREEN



Net wt. 1.05 OZ. / 30 g (15 g x 2)

AIR CUSHION ®

Principal Display Panel 15 G Container Carton 21 Vanilla (PRINCIPAL DISPLAY PANEL - 15 g Container Carton - 21 Vanilla)

IOPE

AIR CUSHION ® COVER 21 VANILLA



BROAD SPECTRUM SPF 50+ SUNSCREEN



Net wt. 1.05 OZ. / 30 g (15 g x 2)

AIR CUSHION ®

Principal Display Panel 15 G Container Carton 31 Warm Beige (PRINCIPAL DISPLAY PANEL - 15 g Container Carton - 31 Warm Beige)

IOPE

IOPE AIR CUSHION ® COVER 31 WARM BEIGE



BROAD SPECTRUM SPF 50+ SUNSCREEN



Net wt. 1.05 OZ. / 30 g (15 g x 2)

AIR CUSHION ®


Advanced Ingredient Data


Raw Label Data

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