NDC 76354-450 Bb Spf20

Octinoxate, Octisalate, Oxybenzone

NDC Product Code 76354-450

NDC 76354-450-28

Package Description: 1 BOTTLE in 1 BOX > 28.5 mL in 1 BOTTLE

NDC Product Information

Bb Spf20 with NDC 76354-450 is a a human over the counter drug product labeled by J. A. Cosmetics U.s. Inc. The generic name of Bb Spf20 is octinoxate, octisalate, oxybenzone. The product's dosage form is cream and is administered via topical form.

Labeler Name: J. A. Cosmetics U.s. Inc

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.

Bb Spf20 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.

  • OCTINOXATE 60 mg/mL
  • OCTISALATE 40 mg/mL
  • OXYBENZONE 35 mg/mL

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.

  • WATER (UNII: 059QF0KO0R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • CYCLOMETHICONE 6 (UNII: XHK3U310BA)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • TALC (UNII: 7SEV7J4R1U)
  • JOJOBA OIL (UNII: 724GKU717M)
  • CUCUMBER (UNII: YY7C30VXJT)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
  • BENTOQUATAM (UNII: 7F465U79Q1)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • ZINC STEARATE (UNII: H92E6QA4FV)
  • ZINC PALMITATE (UNII: Q7407964JA)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • MICA (UNII: V8A1AW0880)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)

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: J. A. Cosmetics U.s. Inc
Labeler Code: 76354
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: 10-20-2019 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.

Bb Spf20 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

Active Ingredients

Octinoxate 6%Octisalate 4%Oxybenzone 3.5%

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

Warnings

For external use only

Do Not Use

  • On damaged or broken skin

When Using This Product

  • Keep out of eyes. Rinse with water to remove.

Stop Use And Ask A Doctor

If rash occurs

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • For sunscreen use:apply liberally 15 minutes before sun exposurereapply at least every 2 hoursuse a water resistant sunscreen if swimming or sweating Sun Protection Measures: Spending time in the sun increases your risk of sun 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 time in the sun, especially from 10 a.m.-2 p.mwear long-sleeved shirts, pants, hats and sunglasseschildren under 6 months of age: Ask doctor.

Inactive Ingredients

Water (Aqua), Propylene Glycol, Glycerin, C12-15 Alkyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Cyclopentasiloxane, Cyclohexasiloxane, Sorbitan Olivate, Polymethyl Methacrylate, Sodium Chloride, Talc, Simmondsia Chinensis (Jojoba) Seed Oil, Cucumis Sativus (Cucumber) Fruit Extract, Aloe Barbadensis Leaf Extract, Bisabolol, Tocopheryl Acetate (Ve), VP/Hexadecene Copolymer, Quaternium-18 Bentonite, Butylene Glycol, Zinc Stearate, Zinc Palmitate, Silica, Mica, Triethoxycaprylylsilane, Phenoxyethanol, Ethylhexylglycerin, Caprylyl Glycol, Fragrance (Parfum) May Contain: Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

* Please review the disclaimer below.