NDC 55910-012 Sunscreen

Avobenzone, Homosalate, Otisalate, Octocrylene

NDC Product Code 55910-012

NDC 55910-012-14

Package Description: 156 g in 1 CAN

NDC 55910-012-15

Package Description: 258 g in 1 CAN

NDC Product Information

Sunscreen with NDC 55910-012 is a a human over the counter drug product labeled by Dolgencorp, Llc. The generic name of Sunscreen is avobenzone, homosalate, otisalate, octocrylene. The product's dosage form is spray and is administered via topical form.

Labeler Name: Dolgencorp, Llc

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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/g
  • HOMOSALATE 225 mg/g
  • OCTISALATE 250 mg/g
  • OCTOCRYLENE 1000 mg/g

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.

  • ALCOHOL (UNII: 3K9958V90M)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • TROLAMINE (UNII: 9O3K93S3TK)

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: 10-01-2019 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 Ingredients

Avobenzone 3%Homosalate 15%Octisalate 5%Octocrylene 10%

Purpose

Sunscreen

Uses

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

Warnings

For external use only

Flammable

  • Keep away from fire or flame.after application, wait until product dries before approaching a souce of heat or flame, or before smoking

Do Not Use

On damaged or broken skin

When Using This Product

  • Keep out of eyes.  Rinse with water to remove.contents under pressure.  Do not puncture or incinerate. Do not store at temperature above 120

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

  • Spray liberally and spread evenly by hand 15 minutes before sun exposure.apply to all skin exposed to the sundo not spray directly into face.  Spray on hands then apply to face.do not apply in windy conditionsuse in a well-ventilated area and avoid inhalationreapply after 80 minutes of swimming or sweatingimmediately after towel dryingat least every 2 hoursSun protction 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 incluing:limit the time in the sun, especially from 10 a.m. - 2 p.m.wear long-sleeved shirts, pants, hats and sunglassescildren under 6 month of age: Ask a doctor

Other Information

  • Protect the product in the container from excessive heat and direct sun

Inactive Ingredients

Alcohol denat., acrylates/octylacrylamide copolymer, glycerin, butyloctyl salicylate, triethanolamine, fragrance

Claims

May stain or damage some fabrics or surfaces Oxybenzone &  Octinoxate free

Disclaimer

This product is not manufactured or distributed by Bayer, distributor of Coppertone Sunscreen Spray Sport Broad Spectrum SPF 70DSP-TN-15000  DSP-MO-34 SDS-TN-15012100%SatisfactionGuaranteed!(888)309-9030

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DISTRIBUTED BY DOLGENCORP, LLC100 MISSION RIDGEGOODLETTSVILLE, TN 37072958.000/958AA

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  • STUDIOSELECTIONSUNSUNSCREENSPRAYBROAD SPECTRUM SPF 70Compare to Coppertone Sport Broad Spectrum SPF 70Water-resistant (80 minutesContinuous spray from any angleSPF 70FamilySizeDermatologist-TestedHypoallergenicNET WT 9.1 OZ (258 g)

* Please review the disclaimer below.