NDC 69039-644 Sun Bum Sunscreen Oil Spf 30 With Coconut Oil

Avobenzone, Homosalate, Octisalate, Octocrylene

NDC Product Code 69039-644

NDC CODE: 69039-644

Proprietary Name: Sun Bum Sunscreen Oil Spf 30 With Coconut Oil 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, Octisalate, Octocrylene 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
    • 69039-644 - Sun Bum Sunscreen Oil Spf 30 With Coconut Oil

NDC 69039-644-01

Package Description: 147 mL in 1 BOTTLE

NDC Product Information

Sun Bum Sunscreen Oil Spf 30 With Coconut Oil with NDC 69039-644 is a a human over the counter drug product labeled by Sun Bum Llc. The generic name of Sun Bum Sunscreen Oil Spf 30 With Coconut Oil is avobenzone, homosalate, octisalate, octocrylene. The product's dosage form is oil and is administered via topical form.

Dosage Form: Oil - An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils.

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 Oil Spf 30 With Coconut Oil 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.


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.

  • POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • ISOAMYL COCOATE (UNII: 14OG46E98E)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • ALCOHOL (UNII: 3K9958V90M)
  • CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
  • POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • JOJOBA OIL (UNII: 724GKU717M)
  • COCOA BUTTER (UNII: 512OYT1CRR)

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: 01-01-2022 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: 12-31-2022 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 Oil Spf 30 With Coconut Oil Product Label Images

Sun Bum Sunscreen Oil Spf 30 With Coconut Oil 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%, Homosalte 10%,


Octisalate 5%, Octocrylene 10%

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

• shake well before use • hold container 4 to 6 inches from the skin to apply • spray liberally and spread evenly by hand 15 minutes before sun exposure • do not spray directly into face. Spray on hands then apply to face. • do not apply in windy conditions • use in a well-ventilated area • 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 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

Inactive Ingredients

Cocos nucifera (coconut) oil, isoamyl cocoate, butyloctyl salicylate, alcohol denat.(5%) capryloyl glycerin/sebacic acid copolymer, polyster-8, polyamide-8, aloe barbadensis leaf extract, helianthus annuus (sunflower) seed oil, tocopherol, simmondsia chinenesis (jojoba) seed oil, theobroma cacao (cocoa) seed butter

Questions?

1-877-978-6286

* Please review the disclaimer below.