Iope Air Cushion Cover 21 Vanilla Lotion
FDA Label NDC 43419-404

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amorepacific Corporation for the product Iope Air Cushion Cover 21 Vanilla (NDC 43419-404). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, use, warnings, when using this product, do not use on, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Otc - Purpose

→ Use

→ Warnings

→ When Using This Product

→ Do Not Use On

→ Stop Use And Ask A Doctor If

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Principal Display Panel - 15 G Container Carton - 13 Ivory

→ Principal Display Panel - 15 G Container Carton - 21 Vanilla

→ Principal Display Panel - 15 G Container Carton - 23 Beige

Other

Drug Facts

Otc - Purpose

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

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.

Warnings

For external use only

When Using This Product

keep out of eyes.
rinse with water to remove.

Do Not Use On

damaged or broken skin.

Stop Use And Ask A Doctor If

rash occurs.

Otc - Keep Out Of Reach Of Children

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.
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.

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.