NDC 69039-603 Sun Bum Sunscreen Lip Balm Broad Spectrum Spf 30 Pomegranate

Avobenzone, Homosalate, Octocrylene, Octisalate

NDC Product Code 69039-603

NDC CODE: 69039-603

Proprietary Name: Sun Bum Sunscreen Lip Balm Broad Spectrum Spf 30 Pomegranate 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: Avobenzone, Homosalate, Octocrylene, Octisalate 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

  • 69039 - Sun Bum Llc
    • 69039-603 - Sun Bum Sunscreen Lip Balm Broad Spectrum Spf 30 Pomegranate

NDC 69039-603-01

Package Description: 4.25 g in 1 TUBE

NDC Product Information

Sun Bum Sunscreen Lip Balm Broad Spectrum Spf 30 Pomegranate with NDC 69039-603 is a a human over the counter drug product labeled by Sun Bum Llc. The generic name of Sun Bum Sunscreen Lip Balm Broad Spectrum Spf 30 Pomegranate is avobenzone, homosalate, octocrylene, octisalate. The product's dosage form is stick and is administered via topical form.

Labeler Name: Sun Bum Llc

Dosage Form: Stick - A dosage form prepared in a relatively long and slender often cylindrical form.

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.

Sun Bum Sunscreen Lip Balm Broad Spectrum Spf 30 Pomegranate 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 30 mg/g
  • HOMOSALATE 100 mg/g
  • OCTOCRYLENE 80 mg/g
  • OCTISALATE 50 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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ARGAN OIL (UNII: 4V59G5UW9X)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • LEMON PEEL (UNII: 72O054U628)
  • CUCUMBER (UNII: YY7C30VXJT)
  • DIISOBUTYL ADIPATE (UNII: 8OPY05ZY7S)
  • EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)
  • ETHYLHEXYL PALMITATE (UNII: 2865993309)
  • GINKGO (UNII: 19FUJ2C58T)
  • HYDROGENATED OLIVE OIL UNSAPONIFIABLES (UNII: B8MIX97W95)
  • ISOSTEARYL LINOLEATE (UNII: 4778M3HR0N)
  • MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • CERESIN (UNII: Q1LS2UJO3A)
  • ASIAN GINSENG (UNII: CUQ3A77YXI)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
  • ROSEMARY (UNII: IJ67X351P9)
  • SACCHARIN (UNII: FST467XS7D)
  • SALIX ALBA BARK (UNII: 205MXS71H7)
  • SAGE (UNII: 065C5D077J)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • COCOA BUTTER (UNII: 512OYT1CRR)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • WATER (UNII: 059QF0KO0R)

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: Sun Bum Llc
Labeler Code: 69039
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: 01-01-2020 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Sun Bum Sunscreen Lip Balm Broad Spectrum Spf 30 Pomegranate Product Label Images

Sun Bum Sunscreen Lip Balm Broad Spectrum Spf 30 Pomegranate 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 10%Octocrylene 8%, Octisalate 5%,

Purpose

Sunscreen

Uses

  • Helps prevent sunburnif 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 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 immediately.

Directions

  • Apply liberally 15 minutes before sun exposurereapply: after 80 minutes of swimming or sweating immediately after towel dryingat least every 2 hourschildren under 6 months of age: ask a doctorSun 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 a.m.-2 p.m.wear long-sleeved shirts, pants, hats and sunglasses

Other Information

Protect this product from excessive heat and direct sun

Inactive Ingredients

Aloe barbadensis leaf extract, argania spinosa kernel oil, bisabolol, camellia sinensis leaf extract, caprylic/capric triglyceride, calendula officinalis flower extract, cetyl alcohol, citrus grandis fruit extract, citrus limon peel extract, cucumis sativus (cucumber) fruit extract, diisobutyl adipate, equisetum arvense extract, ethylhexyl palmitate, fragrance, ginkgo biloba leaf extract, hydrogenated ethylhexyl olivate, hydrogenated olive oil unsaponifiables, isostearyl linoleate, macrocystis pyrifera extract, mineral oil, ozokerite, panax ginseng root extract, PEG-8, polysorbate 80, propylene glycol, punica granatum extract, rosmarinus officinalis extract, saccharin, salix alba (willow) bark extract, salvia officinalis (sage) extract, silica, theobroma cacao seed butter, tocopheryl acetate, tocopheryl linoleate/oleate, water

Questions?

1 (877) 978-6286

* Please review the disclaimer below.