NDC 49035-566 Equate Sunscren Ultra Broad Spectrum Spf 50

Avobenzone Homosalate Octisalate Octocrylene

NDC Product Code 49035-566

NDC Code: 49035-566

Proprietary Name: Equate Sunscren Ultra Broad Spectrum Spf 50 Additional informationCallout TooltipWhat 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: Avobenzone Homosalate Octisalate Octocrylene Additional informationCallout TooltipWhat 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.


Code Structure
  • 49035 - Walmart Stores Inc.
    • 49035-566 - Equate Sunscren Ultra Broad Spectrum Spf 50

NDC 49035-566-14

Package Description: 473 mL in 1 BOTTLE

NDC Product Information

Equate Sunscren Ultra Broad Spectrum Spf 50 with NDC 49035-566 is a a human over the counter drug product labeled by Walmart Stores Inc.. The generic name of Equate Sunscren Ultra Broad Spectrum Spf 50 is avobenzone homosalate octisalate octocrylene. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Walmart Stores 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 Additional informationCallout TooltipWhat 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.


Equate Sunscren Ultra Broad Spectrum Spf 50 Active Ingredient(s)

Additional informationCallout TooltipWhat 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 30 mg/mL
  • HOMOSALATE 130 mg/mL
  • OCTISALATE 50 mg/mL
  • OCTOCRYLENE 70 mg/mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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)
  • TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
  • SORBITOL (UNII: 506T60A25R)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
  • POLYETHYLOXAZOLINE (200000 MW) (UNII: I765I75FT2)
  • CARBOMER 934 (UNII: Z135WT9208)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
  • POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Walmart Stores Inc.
Labeler Code: 49035
FDA Application Number: part352 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 02-21-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Equate Sunscren Ultra Broad Spectrum Spf 50 Product Label Images

Equate Sunscren Ultra Broad Spectrum Spf 50 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 3.0%Homosalate 13.0%Octisalate 5.0%Octocrylene 7.0%

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 onlyDo 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

• apply liberally 15 minutes before sun exposure   • reapply:   • after 80 minutes of swimming or sweating   • immediately after towel drying   • at least every 2 hours• children under 6 months of age: 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 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-sleeve shirts, pants, hats, and sunglasses

Other Information

• protect this product from excessive heat and direct sun• may stain or damage some fabrics/materials or surfaces

Other

Formulated to provide broad spectrum UVA/UVB protection to decrease the risk of skin cancer and early skin aging caused by the sun

Inactive Ingredients

Water, tridecyl salicylate, sorbitol, stearic acid, aluminum starch octenylsuccinate, triethanolamine, polyethyloxazoline, carbomer, dimethicone, tocopherol, disodium EDTA, polyglyceryl-3  distearate, caprylyl glycol, phenoxyethanol, ethylhexyl glycerin, sorbitan isostearate, benzyl alcohol, fragrance

* Please review the disclaimer below.

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