NDC 68828-417 Always Foundation Makeup Broad Spectrum Spf 15 Golden Tan

Octinoxate, Zinc Oxide

NDC Product Code 68828-417

NDC 68828-417-01

Package Description: 30 mL in 1 CARTON

NDC Product Information

Always Foundation Makeup Broad Spectrum Spf 15 Golden Tan with NDC 68828-417 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 Golden Tan is octinoxate, 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 Golden Tan 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.

  • ZINC OXIDE 6.8 g/100mL
  • OCTINOXATE 3 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.

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

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: 07-14-2020 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 Golden Tan Product Label Images

Always Foundation Makeup Broad Spectrum Spf 15 Golden Tan 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

Active Ingredients PurposeOctinoxate 3% SunscreenZinc Oxide 6.8% Sunscreen

Otc - Purpose

UsesHelps 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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of childrenIf 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

WarningsFor external use onlyDo not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove

Dosage & Administration

DirectionsApply liberally 15 minutes before sun exposure

Use a water resistant sunscreen if swimming or sweating

Reapply 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 your 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.

Inactive Ingredient

Inactive ingredientsC12-15 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

* Please review the disclaimer below.