NDC 68828-409 Age And Pollution Protector Broad Spectrum Spf 50

Avobenzone, Homosalate, Octisalate, Octocrylene

NDC Product Code 68828-409

NDC Code: 68828-409

Proprietary Name: Age And Pollution Protector Broad Spectrum 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: Avobenzone, Homosalate, Octisalate, Octocrylene 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

  • 68828 - Jafra Cosmetics International
    • 68828-409 - Age And Pollution Protector Broad Spectrum Spf 50

NDC 68828-409-01

Package Description: 7.5 mL in 1 BOTTLE

NDC 68828-409-02

Package Description: 14 mL in 1 BOTTLE

NDC 68828-409-03

Package Description: 50 mL in 1 BOTTLE

NDC Product Information

Age And Pollution Protector Broad Spectrum Spf 50 with NDC 68828-409 is a a human over the counter drug product labeled by Jafra Cosmetics International. The generic name of Age And Pollution Protector Broad Spectrum Spf 50 is avobenzone, homosalate, octisalate, octocrylene. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Jafra Cosmetics International

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Age And Pollution Protector Broad Spectrum 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.

  • AVOBENZONE 3 g/100mL
  • HOMOSALATE 10 g/100mL
  • OCTOCRYLENE 10 g/100mL
  • OCTISALATE 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.

  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • SOYBEAN (UNII: L7HT8F1ZOD)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
  • HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • AVOCADO OIL (UNII: 6VNO72PFC1)
  • POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SQUALANE (UNII: GW89575KF9)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • WATER (UNII: 059QF0KO0R)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • COCOA (UNII: D9108TZ9KG)
  • CERIC OXIDE (UNII: 619G5K328Y)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • ROYAL JELLY (UNII: L497I37F0C)
  • PYRROLIDONE CARBOXYLIC ACID (UNII: 6VT1YZM21H)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
  • POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
  • CERAMIDE NP (UNII: 4370DF050B)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • OLIVE OIL (UNII: 6UYK2W1W1E)

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: 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: 07-09-2019 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.

Age And Pollution Protector Broad Spectrum Spf 50 Product Label Images

Age And Pollution Protector Broad Spectrum 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

Active Ingredients PurposeAvobenzone 3% SunscreenHomosalate 10% SunscreenOctisalate 5% SunscreenOctocrylene 10% Sunscreen

Otc - Purpose

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

Dosage & Administration

DirectionsApply generously and evenly 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 ingredients
Alumina, Butylene Glycol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ceramide 3, Cerium Oxide, Dipropylene Glycol, Ethylhexyl Methoxycrylene, Ethylhexylglycerin, Fragrance/Parfum, Glycerin, Glyceryl Stearate, Glycine Soja (Soybean) Seed Extract, Hexylene Glycol, Hydrogenated Lecithin, Hydroxyethyl Acrylate/ Sodium Acryloyldimethyltaurate Copolymer, Lecithin, Maltodextrin, Olea Europaea (Olive) Fruit Oil, PEG-100 Stearate, Persea Gratissima (Avocado) Oil, Phenethyl Alcohol, Phenoxyethanol, Phytosterols, Polyester-8, Polymethyl Methacrylate, Polysorbate 60, Potassium Sorbate, Royal Jelly Powder, Royal Jelly, Sodium Benzoate, Sodium Hyaluronate, Sodium PCA, Squalane, Styrene/Acrylates Copolymer, Sucrose Stearate, Tetrapeptide-45, Theobroma Cacao (Cocoa) Seed Extract, Tocopherol, Tocopheryl Acetate, Tuber Magnatum Extract, VP/Eicosene Copolymer, Water/Aqua, Xanthan Gum

* Please review the disclaimer below.

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