NDC 72498-000 02 Cushion Spf45 Sunscreen

Sunscreen

NDC Product Code 72498-000

NDC 72498-000-01

Package Description: 1 JAR in 1 BOX > 30 mL in 1 JAR

NDC Product Information

02 Cushion Spf45 Sunscreen with NDC 72498-000 is a a human over the counter drug product labeled by Coiz Co Ltd. The generic name of 02 Cushion Spf45 Sunscreen is sunscreen. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Coiz Co Ltd

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

02 Cushion Spf45 Sunscreen Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • OCTISALATE 5 g/100mL
  • TITANIUM DIOXIDE 13.5 g/100mL
  • OCTOCRYLENE 2.5 g/100mL
  • ZINC OXIDE 8 g/100mL
  • OCTINOXATE 5 g/100mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • DIMETHICONE PEG-8 LAURATE (UNII: 72MF9C2A18)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • OXYGEN (UNII: S88TT14065)
  • PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • HAMAMELIS VIRGINIANA FLOWER WATER (UNII: 222MYC9QUV)
  • BROWN IRON OXIDE (UNII: 1N032N7MFO)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • HEXYL LAURATE (UNII: 4CG9F9W01Q)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
  • ADENOSINE (UNII: K72T3FS567)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • CENTELLA ASIATICA (UNII: 7M867G6T1U)
  • CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)
  • MICA (UNII: V8A1AW0880)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • WATER (UNII: 059QF0KO0R)
  • ABIES KOREANA LEAF (UNII: QJK99UC36Q)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Coiz Co Ltd
Labeler Code: 72498
FDA Application Number: part352 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-30-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

02 Cushion Spf45 Sunscreen Product Label Images

02 Cushion Spf45 Sunscreen Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

Ethylhexyl Methoxycinnamate 7.0%Ethylhexyl Salicylate 5.0%Octocrylene 2.5%Titanium Dioxide 13.5%Zinc Oxide 5.0%

Purpose

Sunscreen

Uses

  • Helps prevent sunburnif used as directed with other sun protection measures (see
  • Directions), decreases the risk of skin cancer and early skin aging caused by sun

Warnings

For external use only

Do Not Use

Do not use on damaged or broken skin

When Using

When using this product keep out of eyes. Rinse with water to remove.

Stop Use

Stop use and ask a doctor if rash occurs

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

▪ Using puff applicator, press down lightly onto presaturated cushion sponge to capture product. For maximum coverage, pat evenly over face. For light coverage, smooth over face using sweeping motion.

▪ Apply liberally and evenly 15 minutes before sun exposure ▪ Reapply ▪ After 80 minutes of swimming or

sweating ▪ Immediately after towel drying ▪ 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. - 2 p.m. ▪ Wear long-sleeved shirts, pants,

hats, and sunglasses ▪ Use a water-resistant sunscreen if swimming or sweating.

Other Information

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

Inactive Ingredients

1,2-hexandiol, Adenosine, Alumina, Caprylic/capric triglyceride, Centella asiatica extract, Cetyl PEG/Ppg-10/1 dimethicone, Cyclopentasiloxane, Disodium EDTA, Disteardimonium hectorite, Fragrance, Glacier water, Glycerin, Hamamelis virginiana (witch hazel) extract, Hexyl laurate, Iron oxides (CI77491), Iron oxides (CI77492), Iron oxides (CI77499), Lauryl PEG-8 dimethicone, Mica, Nicinamide, Oxygen, PEG-10 dimethicone, Polyhydroxystearic acid, Sodium chloride, Sodium Hyaluronate, Stearic acid, Tocopheryl acetate, Triethoxycaprylylsilane, Water.

* Please review the disclaimer below.