NDC 68828-426 Always Foundation Makeup Broad Spectrum Spf 15 Shell

Homosalate, Octisalate, Zinc Oxide

NDC Product Code 68828-426

NDC 68828-426-01

Package Description: 30 mL in 1 TUBE

NDC Product Information

Always Foundation Makeup Broad Spectrum Spf 15 Shell with NDC 68828-426 is a a human over the counter drug product labeled by Jafra Cosmetics International. The generic name of Always Foundation Makeup Broad Spectrum Spf 15 Shell is homosalate, octisalate, zinc oxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Jafra Cosmetics International

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.

Always Foundation Makeup Broad Spectrum Spf 15 Shell 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.

  • HOMOSALATE 4.25 g/100mL
  • OCTISALATE 4.75 g/100mL
  • ZINC OXIDE 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.

  • KAOLIN (UNII: 24H4NWX5CO)
  • PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
  • WHITE SPIRIT TYPE 1 (UNII: 37LNJ1I16R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • PROPYLENE CARBONATE (UNII: 8D08K3S51E)
  • SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • WATER (UNII: 059QF0KO0R)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • METHICONE (20 CST) (UNII: 6777U11MKT)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)

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.
  • 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: Jafra Cosmetics International
Labeler Code: 68828
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: 08-24-2020 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: 12-31-2021 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.

Always Foundation Makeup Broad Spectrum Spf 15 Shell Product Label Images

Always Foundation Makeup Broad Spectrum Spf 15 Shell 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

Homosalate 4.25% Purpose SunscreenOctisalate 4.75% Purpose SunscreenZinc Oxide 7.0% 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 the sun

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.

Indications & Usage

Stop use and ask a doctor if rash occurs

Warnings

For external use onlyDo not use on damaged or broken skin
Stop use and ask a doctor if rash occursWhen using this product keep out of eyes. Rinse with water to remove.

Dosage Forms & Strengths

  • Apply liberally 15 minutes before sun exposureUse a water resistant sunscreen if swimming or sweatingReapply at least every 2 hoursChildren under 6 months: Ask a doctorSun 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

Inactive Ingredient

C12-15 Alkyl Benzoate, Caprylyl Glycol, Caprylyl Methicone, Dimethicone, Dimethicone Crosspolymer, Ethylhexylglycerin, Glycerin, Hexylene Glycol, Hydroxypropylcocoate PEG-8 Dimethicone, Iron Oxides/CI 77491/CI 77492/CI 77499, Kaolin, Lecithin, Methicone, Phenoxyethanol, Phenyl Trimethicone, Propylene carbonate, Silica, Silica Dimethyl Silylate, Sodium Chloride, Stoddard solvent, Titanium Dioxide/CI 77891, Triethoxycaprylysilane, Water/Aqua

Other Safety Information

Protect this product from excessive heat and direct sun

* Please review the disclaimer below.