NDC 69435-1906 Xxl Demi Make Up Spf 50

Octinoxate, Octocrylene, Octisalate, Avobenzone, Homosalate Cream

NDC Product Code 69435-1906

NDC Code: 69435-1906

Proprietary Name: Xxl Demi Make Up Spf 50 What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Octinoxate, Octocrylene, Octisalate, Avobenzone, Homosalate Cream What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 69435 - Peer Pharma Ltd.

NDC 69435-1906-1

Package Description: 100 mL in 1 CONTAINER

NDC Product Information

Xxl Demi Make Up Spf 50 with NDC 69435-1906 is a a human over the counter drug product labeled by Peer Pharma Ltd.. The generic name of Xxl Demi Make Up Spf 50 is octinoxate, octocrylene, octisalate, avobenzone, homosalate cream. The product's dosage form is cream and is administered via topical form.

Labeler Name: Peer Pharma Ltd.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Xxl Demi Make Up Spf 50 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.

  • OCTOCRYLENE 4 g/100mL
  • OCTISALATE 5 g/100mL
  • AVOBENZONE 3 g/100mL
  • HOMOSALATE 13 g/100mL
  • OXYBENZONE 7 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.

  • JOJOBA OIL (UNII: 724GKU717M)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • ALMOND OIL (UNII: 66YXD4DKO9)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • ALLANTOIN (UNII: 344S277G0Z)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)
  • ISOHEXADECANE (UNII: 918X1OUF1E)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • SEA SALT (UNII: 87GE52P74G)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
  • AVOCADO OIL (UNII: 6VNO72PFC1)
  • WATER (UNII: 059QF0KO0R)
  • DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)

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: Peer Pharma Ltd.
Labeler Code: 69435
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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 09-06-2019 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.

Xxl Demi Make Up Spf 50 Product Label Images

Xxl Demi Make Up Spf 50 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

Otc - Active Ingredient

Oxybenzone​ 7%Octocrylene 4%Octisalate 5%Avobenzone 3%Homosalate 13%

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Otc - Purpose

Provides SPF 50 protection

Indications & Usage

Directions for Use: Apply generously to face and body regularly before sun exposure and as needed.Reapply: after 40 minutes before of or 80 minutes of swimming or sweating, immediately after towel drying, and at least every 2 hours.

Dosage & Administration

Directions for Use: Apply generously to face and body regularly before sun exposure and as needed. Reapply: after 40 minutes before of or 80 minutes of swimming or sweating, immediately after towel drying, and at least every 2 hours.

* Please review the disclaimer below.