NDC 51514-0356 Benefit Weightless Moisture Face Moisturizer Broad Spectrum Spf 15 Sunscreen

Octocrylene, Homosalate, Avobenzone

NDC Product Code 51514-0356

NDC CODE: 51514-0356

Proprietary Name: Benefit Weightless Moisture Face Moisturizer Broad Spectrum Spf 15 Sunscreen 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: Octocrylene, Homosalate, Avobenzone 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

  • 51514 - Autumn Harp, Inc.
    • 51514-0356 - Benefit Weightless Moisture Face Moisturizer Broad Spectrum Spf 15 Sunscreen

NDC 51514-0356-1

Package Description: 1 BOTTLE, PUMP in 1 CARTON > 50 mg in 1 BOTTLE, PUMP

NDC Product Information

Benefit Weightless Moisture Face Moisturizer Broad Spectrum Spf 15 Sunscreen with NDC 51514-0356 is a a human over the counter drug product labeled by Autumn Harp, Inc.. The generic name of Benefit Weightless Moisture Face Moisturizer Broad Spectrum Spf 15 Sunscreen is octocrylene, homosalate, avobenzone. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Autumn Harp, Inc.

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.

Benefit Weightless Moisture Face Moisturizer Broad Spectrum Spf 15 Sunscreen 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 2.5 mg/100mg
  • HOMOSALATE 3 mg/100mg
  • OCTOCRYLENE 4 mg/100mg

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.

  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)
  • POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
  • SALICYLIC ACID (UNII: O414PZ4LPZ)
  • LENTIL (UNII: 6O38V6B52O)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • PYRROLIDONE CARBOXYLIC ACID (UNII: 6VT1YZM21H)
  • .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
  • APPLE FRUIT OIL (UNII: 9NT987I3A8)
  • SODIUM LACTATE (UNII: TU7HW0W0QT)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • CYCLOMETHICONE 4 (UNII: CZ227117JE)
  • CITRONELLENE LACTONE (UNII: HHU24873T9)
  • BENZYL BENZOATE (UNII: N863NB338G)
  • CITRAL (UNII: T7EU0O9VPP)
  • GERANIOL (UNII: L837108USY)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
  • LINALOOL, (+)- (UNII: F4VNO44C09)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • FARNESOL (UNII: EB41QIU6JL)
  • ETHYLHEXYL PALMITATE (UNII: 2865993309)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
  • DIMETHICONE 20 (UNII: H8YMB5QY0D)
  • WATERMELON (UNII: 231473QB6R)
  • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • LAURETH-12 (UNII: OAH19558U1)
  • ISOEUGENOL (UNII: 5M0MWY797U)

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: Autumn Harp, Inc.
Labeler Code: 51514
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: 03-01-2020 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.

Benefit Weightless Moisture Face Moisturizer Broad Spectrum Spf 15 Sunscreen 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

Octocrylene 4.00%Homosalate 3.00%Avobenzone 2.50%

Purpose

SunscreenSunscreenSunscreen

Uses

Helps prevent sunburnIf used as directed with other sun protection measures
(see Directions), decreases the risk of skin cnacer and early skin aging caused by the sun.

Warnings

For external use onlyDo not use ​on damaged or broken skin.
When using this product keep out of eyes. RInse with water to remove.
Discontinue 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

  • Apply generously and evenly every morning on cleansed face and neck 15 minutes before sun exposureFor sunscreen use:reapply at least every 2 hoursuse a water-resistant sunscreen if swimming or sweatingSun Protection Measures. Spending time
  • ​in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regulary 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.m.wear long-sleeved shirts, pants, hats, and sunglassesFor use on children less than 6 months of age, consult a doctor.

Other Information

  • ​​protect the product in this container from excessive heat and direct sun

Inactive Ingredients

Water, Diisopropyl Adipate, Neopentyl Glycol Diheptanoate, Glycerin, Ethylhexyl Palmitate, Polysilicone-11, Polymethyl Methacrylate, Cetearyl Alcohol, Pentylene Glycol, Dimethicone, Phenoxyethanol, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Glucoside, Camellia Japonica Seed Oil, Citrullus Lanatus (Watermelon) Fruit Extract, Chlorphenesin, Lens Esculenta (Lentil) Fruit Extract, Fragrance, Pyrus Malus (Apple) Fruit Extract, Xanthan Gum, Ethylhexylglycerin, Laureth-12, Sodium Lactate, Sodium PCA, Linalool, Aloe Barbadensis Leaf Juice, Potassium Sorbate, Sodium Benzoate, Hexyl Cinnamal, d-Limonene, BHT, Citric Acid, Cyclopentasiloxane, Cyclotetrasiloxane, Sodium Hydroxide, Citronellol, Benzyl Benzoate.

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