NDC 55910-877 Sunscreen

Avobenzone, Homosalate, Octisalat, Octocrylene

NDC Product Code 55910-877

NDC 55910-877-21

Package Description: 88 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Sunscreen with NDC 55910-877 is a a human over the counter drug product labeled by Dolgencorp, Llc. The generic name of Sunscreen is avobenzone, homosalate, octisalat, octocrylene. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Dolgencorp, Llc

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.

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 90 mg/mL
  • HOMOSALATE 2250 mg/mL
  • OCTISALATE 250 mg/mL
  • OCTOCRYLENE 1000 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)
  • DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
  • STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

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: Dolgencorp, Llc
Labeler Code: 55910
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: 11-15-2019 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: 12-31-2021 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.

Sunscreen Product Label Images

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 Ingredient

Avobenzone Homosalate OctisalateOctocrylene

Purpose

Sunscreen

Uses

  • Helps prevent sunburnif used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer

Warnings

For external use only-handsFlammable. Keep away from heat and flame

When Using This Product

  • Keep out of eyes. In case of contact with the eyes, flush thoroughly with water.avoid contact with broken skindo not inhale or ingestavoid contact with broken skin

Stop Use And Ask A Doctor If

Skin irritation develops

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

Directions

  • Wet hands thoroughly with product and allow to dry without wipingfor children under 6, use only under adult supervisionnot recommended for infants

Other Information

  • Do not store about 105⁰F may discolor some fabrics harmful to wood finishes and plastics.

Inactive Ingredients

Water, diethylhexyl 2,6-naphthalate, styrene/acrylates copolymer, silica, glyceryl stearate, PEG-100 stearate, beeswax, cyclopentasiloxane, acrylates/dimethicone copolymer, acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, chlorphenesin, benzyl alcohol, triethanolamine, disodium EDTA, BHT

Adverse Reactions

DISTRIBUTED BY DOLGENCORP, LLC100 MISSION RIDGEGOODLETTSVILLE, TN 37072

* Please review the disclaimer below.