NDC 68828-283 3-in-1 Face Moisturizer Broad Spectrum Spf 20

Avobenzone, Homosalate, Octisalate, Octocrylene

NDC Product Code 68828-283

NDC Code: 68828-283

Proprietary Name: 3-in-1 Face Moisturizer Broad Spectrum Spf 20 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
    • 68828-283 - 3-in-1 Face Moisturizer Broad Spectrum Spf 20

NDC 68828-283-01

Package Description: 75 mL in 1 CARTON

NDC Product Information

3-in-1 Face Moisturizer Broad Spectrum Spf 20 with NDC 68828-283 is a a human over the counter drug product labeled by Jafra Cosmetics International. The generic name of 3-in-1 Face Moisturizer Broad Spectrum Spf 20 is avobenzone, homosalate, octisalate, octocrylene. The product's dosage form is jelly and is administered via topical form.

Labeler Name: Jafra Cosmetics International

Dosage Form: Jelly - A class of gels, which are semisolid systems that consist of suspensions made up of either small inorganic particles or large organic molecules interpenetrated by a liquid--in which the structural coherent matrix contains a high portion of liquid, usually water.

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.

3-in-1 Face Moisturizer Broad Spectrum Spf 20 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
  • OCTOCRYLENE 10 g/100mL
  • HOMOSALATE 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.

  • ROYAL JELLY (UNII: L497I37F0C)
  • SALIX ALBA BARK (UNII: 205MXS71H7)
  • UREA (UNII: 8W8T17847W)
  • DOCOSANOL (UNII: 9G1OE216XY)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • TRIACETIN (UNII: XHX3C3X673)
  • CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
  • ALLANTOIN, (+)- (UNII: XDK458E1J9)
  • ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
  • C13-16 ISOPARAFFIN (UNII: LED42LZG6O)
  • CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
  • LAUROYL LYSINE (UNII: 113171Q70B)
  • PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
  • POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
  • POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
  • WATER (UNII: 059QF0KO0R)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
  • CAFFEINE (UNII: 3G6A5W338E)
  • CITRAL (UNII: T7EU0O9VPP)
  • .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • COCOA (UNII: D9108TZ9KG)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
  • HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • COUMARIN (UNII: A4VZ22K1WT)
  • ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • PYRROLIDONE CARBOXYLIC ACID (UNII: 6VT1YZM21H)
  • ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
  • ARGININE (UNII: 94ZLA3W45F)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • TREHALOSE (UNII: B8WCK70T7I)

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: 03-27-2019 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.

3-in-1 Face Moisturizer Broad Spectrum Spf 20 Product Label Images

3-in-1 Face Moisturizer Broad Spectrum Spf 20 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 ingredient PurposeAvobenzone 3% SunscreenHomosalate 10% SunscreenOctisalate 5% SunscreenOctocrylene 10% 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

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

Indications & Usage

Stop use and ask a doctor if
rash occurs or irritation develops and lasts.

Dosage & Administration

  • Directions Apply liberally 15 minutes before sun exposureUse a water resistant sunscreen if swimming or sweatingreapply at leastevery 2 hours.Children under 6 months of age: ask a doctor. •
  • 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

Inactive Ingredient

Inactive ingredients: Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aluminum Starch Octenylsuccinate, Arachidyl

Alcohol, Arachidyl Glucoside, Arginine, Behenyl Alcohol, Blsabolol, Butylene Glycol, Butyloctyl Salicylate, Butylphenyl Methylpropional (LIIIIal), Butyrospanmum Parkll (Shea) Butter, C13-16 Isoparaffin, Caffeine, Capryloyl Glycerin/Sabacic Acid Copolymer, Cetyl Alcohol, citral, citronellol, Coumarin, Dimethicone, Dipropylene Glycol, Disodium EDTA, Ethylhexyl Methoxycrylene, Ethylhexylglycerin, Fragrance/Parfum, Glycerin, Glyceryl Stearate, Heptyl Undecylenate, Hydrogenated Lecithin, Lauroyl Lysine, Lecithin, Limonene, Linalool, Maltodextrin, PEG-100 Stearate, Phenethyl Alcohol, Phenoxyethanol, Polyester-8, Polyquatemlum-51, Quercus Petraea Fruit Extract, Royal Jelly Powder, Royal Jelly, Salix Alba (Willow) Bark Extract, Silica, Sodium Acrylates Crosspolymer-2, Sodium Hyaluronate, Sodium PCA, Styrene/Acrylates Copolymer, Tetrapeptide-45, Theobroma Cacao (Cocoa) Seed Extract, Tocopherol, Trehalose, Triacetin, Urea, Water/Aqua, Xanthan Gum, Yeast Extract

* Please review the disclaimer below.

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