NDC 0311-0709 Almay Anti Aging Lip Care Spf 20

Octinoxate, Octisalate, Homosalate, Oxybenzone, Avobenzone

NDC Product Code 0311-0709

NDC Code: 0311-0709

Proprietary Name: Almay Anti Aging Lip Care 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: Octinoxate, Octisalate, Homosalate, Oxybenzone, 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

  • 0311 - Almay, Inc.
    • 0311-0709 - Almay Anti Aging Lip Care Spf 20

NDC 0311-0709-01

Package Description: 6.8 mL in 1 CONTAINER

NDC Product Information

Almay Anti Aging Lip Care Spf 20 with NDC 0311-0709 is a a human over the counter drug product labeled by Almay, Inc.. The generic name of Almay Anti Aging Lip Care Spf 20 is octinoxate, octisalate, homosalate, oxybenzone, avobenzone. The product's dosage form is lipstick and is administered via topical form.

Labeler Name: Almay, Inc.

Dosage Form: Lipstick - A waxy solid, usually colored cosmetic, in stick form for the lips.

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.

Almay Anti Aging Lip Care 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.

  • OCTINOXATE 7.5 mg/mL
  • HOMOSALATE 5 mg/mL
  • AVOBENZONE 3 mg/mL
  • OCTISALATE 5 mg/mL
  • OXYBENZONE 5 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.

  • POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
  • DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
  • BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
  • OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
  • C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
  • TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
  • NYLON-12 (UNII: 446U8J075B)
  • COCONUT (UNII: 3RT3536DHY)
  • ETHYLHEXYL PALMITATE (UNII: 2865993309)
  • CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
  • MICA (UNII: V8A1AW0880)
  • MENTHOL (UNII: L7T10EIP3A)
  • MAGNESIUM SULFATE (UNII: DE08037SAB)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
  • SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
  • SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
  • WATER (UNII: 059QF0KO0R)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SUCROSE COCOATE (UNII: 3H18P0UK73)
  • HYALURONIC ACID (UNII: S270N0TRQY)
  • SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • CERESIN (UNII: Q1LS2UJO3A)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)

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: Almay, Inc.
Labeler Code: 0311
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: 04-20-2016 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: 12-31-2018 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: E 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.

Almay Anti Aging Lip Care Spf 20 Product Label Images

Almay Anti Aging Lip Care 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

Active Ingredients:

Octinoxate - 7.5%Octisalate 5%Homosalate 5.0%Oxybenzone 5.0%Avobenzone 3%

Purpose

Sunscreen

Uses:

•Helps 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

Warnings:

•For external use only








•Do notuse 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 a rash occurs








•Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control center right away

Directions

•Apply liberally 15 minutes before sun exposure








•Use a water resistant sunscreen if swimming or sweating








•Reapply at least every 2 hours








•Children under 6 months: 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 time in the sun, especially from 10 am - 2 pm








•Wear long-sleeved shirts, pants, hats and sunglasses.

Inactive Ingredients

Polybutene, Diisostearyl Malate, Bis-Diglyceryl Polyacyladipate-2, Ozokerite, Octyldodecyl Neopentanoate, Petrolatum, Polyethylene, C10-30 Cholesterol/Lanosterol Esters, Synthetic Fluorphlogopite, Silica, Paraffin, Butyrospermum Parkii (Shea) Butter, Argania Spinosa Kernel Oil, Dimethicone, Synthetic Wax, Nylon-12, Cocos Nucifera (Coconut) Oil, Ethylhexyl Palmitate, Cetearyl Ethylhexanoate, Mica, Flavor, Tocopheryl Acetate, Diisopropyl Dimer Dilinoleate, Menthol, Titanium Dioxide (CI 77891), Benzoic Acid, BHT, Phospholipids, Sorbitan Isostearate, Sodium Saccharin, Silica Dimethyl Silylate, Portulaca Pilosa Extract, Aqua/Water/Eau, Caprylyl Glycol, Butylene Glycol, Phenoxyethanol, Sucrose Cocoate, Hyaluronic Acid, Sodium Chondroitin Sulfate, Atelocollagen, Tocopherol, Sodium Hyaluronate, Hexylene Glycol, Soluble Collagen, Tripeptide-29, Palmitoyl Tripeptide-38, Methyl Acetylglycyrrhetinoyl Hydroxyprolinate

* Please review the disclaimer below.

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