NDC 77365-003 Sunproof Intensive Lip Balm Broad Spectrum Spf 24 Sunscreen Sweet Tangerine

Avobenzone, Homosalate, And Octisalate

NDC Product Code 77365-003

NDC CODE: 77365-003

Proprietary Name: Sunproof Intensive Lip Balm Broad Spectrum Spf 24 Sunscreen Sweet Tangerine 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, And 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.

Product Characteristics

Color(s):
YELLOW (C48330)
Flavor(s):
TANGERINE (C73418)

NDC Code Structure

  • 77365 - Thrive Causemetics
    • 77365-003 - Sunproof Intensive Lip Balm Broad Spectrum Spf 24 Sunscreen Sweet Tangerine

NDC 77365-003-01

Package Description: 1 TUBE in 1 BOX > 8 g in 1 TUBE

NDC Product Information

Sunproof Intensive Lip Balm Broad Spectrum Spf 24 Sunscreen Sweet Tangerine with NDC 77365-003 is a a human over the counter drug product labeled by Thrive Causemetics. The generic name of Sunproof Intensive Lip Balm Broad Spectrum Spf 24 Sunscreen Sweet Tangerine is avobenzone, homosalate, and octisalate. The product's dosage form is lipstick and is administered via topical form.

Labeler Name: Thrive Causemetics

Dosage Form: Lipstick - A waxy solid, usually colored cosmetic, in stick form for the lips.

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.

Sunproof Intensive Lip Balm Broad Spectrum Spf 24 Sunscreen Sweet Tangerine 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
  • 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.

  • SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • COCOA BUTTER (UNII: 512OYT1CRR)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
  • BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
  • BEHENYL BEHENATE (UNII: K8NU647RJ0)
  • ORANGE OIL (UNII: AKN3KSD11B)
  • CANDELILLA WAX (UNII: WL0328HX19)
  • STEARYL BEHENATE (UNII: A68S9UI39D)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • ARGAN OIL (UNII: 4V59G5UW9X)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • MAGNESIUM ASPARTATE (UNII: R17X820ROL)
  • ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
  • MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
  • PASSIFLORA INCARNATA SEED OIL (UNII: S0SU5AC95J)
  • COPPER GLUCONATE (UNII: RV823G6G67)
  • SWEET CHERRY SEED OIL (UNII: 9X3RP3RJFH)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
  • HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)

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: Thrive Causemetics
Labeler Code: 77365
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: 05-12-2021 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.

Sunproof Intensive Lip Balm Broad Spectrum Spf 24 Sunscreen Sweet Tangerine Product Label Images

Sunproof Intensive Lip Balm Broad Spectrum Spf 24 Sunscreen Sweet Tangerine 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

Other

Drug Facts

Dist. by Thrive Causemetics, Inc. Los Angeles, CA 90045

Otc - Purpose

Active ingredientsPurposeAvobenzone 3.0%SunscreenHomosalate 10.0%SunscreenOctisalate 5.0%Sunscreen

Uses

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

Warnings

For external use only.

Do Not Use

  • On damaged or broken skin.

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if rash occurs.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • For sunscreen use:Apply liberally 15 minutes before sun exposure.Reapply at least every 2 hours.Use a water resistant sunscreen if swimming or sweating.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 am. - 2 pm.Wear long-sleeved shirts, pants, and sunglasses.

Other Information

  • Protect this product from excessive heat and direct sun.

Inactive Ingredients

SYNTHETIC BEESWAX, POLYHYDROXYSTEARIC ACID, THEOBROMA CACAO (COCOA) SEED BUTTER, BUTYROSPERMUM PARKII (SHEA) BUTTER, BUTYLOCTYL SALICYLATE, C32-36 ISOALKYL STEARATE, ALUMINUM STARCH OCTENYLSUCCINATE, BIS-DIGLYCERYL POLYACYLADIPATE-2, BEHENYL BEHENATE, CITRUS AURANTIUM DULCIS (ORANGE) OIL, EUPHORBIA CERIFERA (CANDELILLA) WAX (CANDELILLA CERA), STEARYL BEHENATE, LIMONENE, CETEARYL ALCOHOL, ARGANIA SPINOSA KERNEL OIL, POLYGLYCERYL-3 STEARATE, PUNICA GRANATUM STEROLS, PANTHENOL (VITAMIN B5), SODIUM HYALURONATE, MAGNESIUM ASPARTATE, ZINC GLUCONATE, MANGIFERA INDICA (MANGO) SEED BUTTER, PASSIFLORA INCARNATA SEED OIL, COPPER GLUCONATE, PRUNUS AVIUM (SWEET CHERRY) SEED OIL, POLYSORBATE 60, RICINUS COMMUNIS (CASTOR) SEED OIL, STEVIA REBAUDIANA EXTRACT, HYDROGENATED CASTOR OIL, LINALOOL

Questions?

Call (888) 804-4318 or visit www.thrivecausemetics.com

* Please review the disclaimer below.