NDC 70170-0013 Eos Active With Aloe Spf 30 Sunscreen Lip Balm

Avobenzone, Homosalate, And Octocrylene

NDC Product Code 70170-0013

NDC CODE: 70170-0013

Proprietary Name: Eos Active With Aloe Spf 30 Sunscreen Lip Balm 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 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

  • 70170 - Eos Products Llc
    • 70170-0013 - Eos Active With Aloe Spf 30 Sunscreen Lip Balm

NDC 70170-0013-2

Package Description: 1 CONTAINER in 1 BLISTER PACK > 7 g in 1 CONTAINER (70170-0013-1)

NDC Product Information

Eos Active With Aloe Spf 30 Sunscreen Lip Balm with NDC 70170-0013 is a a human over the counter drug product labeled by Eos Products Llc. The generic name of Eos Active With Aloe Spf 30 Sunscreen Lip Balm is avobenzone, homosalate, and octocrylene. The product's dosage form is stick and is administered via topical form.

Labeler Name: Eos Products 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.

Eos Active With Aloe Spf 30 Sunscreen Lip Balm 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 .21 g/7g
  • HOMOSALATE .7 g/7g
  • OCTOCRYLENE .7 g/7g

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.

  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
  • JOJOBA OIL (UNII: 724GKU717M)
  • HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • COCOA BUTTER (UNII: 512OYT1CRR)
  • ALOE (UNII: V5VD430YW9)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
  • ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)
  • ELETTARIA CARDAMOMUM WHOLE (UNII: KH2S76267N)
  • APPLE FRUIT OIL (UNII: 9NT987I3A8)
  • RUBUS IDAEUS FRUIT VOLATILE OIL (UNII: 276X2YNL0K)
  • CANANGA ODORATA FLOWER (UNII: 76GTF6Z97M)
  • BITTER ORANGE OIL (UNII: 9TLV70SV6I)
  • BERGAMOT OIL (UNII: 39W1PKE3JI)
  • ARABICA COFFEE OIL (UNII: IK55HKE887)
  • CUCUMIS MELO WHOLE (UNII: RDC232W0M5)
  • CUCUMBER FRUIT OIL (UNII: R81Y52NPCT)
  • CUPRESSUS SEMPERVIRENS LEAF OIL (UNII: M7QUY89S4O)
  • CUCUMIS MELO VAR. CANTALUPENSIS WHOLE (UNII: HUU66O04OX)
  • JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
  • ROSE OIL (UNII: WUB68Y35M7)
  • ROSEMARY OIL (UNII: 8LGU7VM393)
  • SAGE OIL (UNII: U27K0H1H2O)
  • SANDALWOOD OIL (UNII: X7X01WMQ5F)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • GLYCINE (UNII: TE7660XO1C)
  • POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
  • STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • LINALOOL, (+)- (UNII: F4VNO44C09)
  • HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
  • ISOAMYL CINNAMATE (UNII: AB60R20S7J)
  • 6-METHYL CITRONELLOL (UNII: 6501AS7W5M)

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: Eos Products Llc
Labeler Code: 70170
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: 12-02-2019 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: 12-31-2020 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.

Eos Active With Aloe Spf 30 Sunscreen Lip Balm Product Label Images

Eos Active With Aloe Spf 30 Sunscreen Lip Balm 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

Otc - Purpose

Active ingredients        PurposeAvobenzone 3%                SunscreenHomosalate 10%               SunscreenOctocrylene 10%               Sunscreen

Uses

  • Helps prevent sunburn.

Warnings

For external use only.

Otc - Do Not Use

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

  • Apply liberally 15 minutes before sun exposureReapply:- after 80 minutes of swimming or sweating- at 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

Inactive Ingredients

Beeswax/Cera Alba (Cire d’abeille), Bis-Diglyceryl Polyacyladipate-2, Jojoba Esters, Helianthus Annuus(Sunflower) Seed Oil, Cocos Nucifera (Coconut) Oil, Butyloctyl Salicylate, Oryza Sativa (Rice) Bran Wax, Helianthus Annuus (Sunflower)Seed Wax, Ricinus Communis (Castor) Seed Oil, Ethylhexyl Methoxycrylene, Butyrospermum Parkii (Shea) Butter, TheobromaCacao (Cocoa) Seed Butter, Aloe Barbadensis Leaf Juice, Triethyl Citrate, Acacia Decurrens Flower Wax, Lavandula Angustifolia (Lavender)Extract, Camellia Sinensis Leaf Extract, Elettaria Cardamomum Seed Extract, Pyrus Malus (Apple) Fruit Extract, Rubus Idaeus (Raspberry)Fruit Extract, Cananga Odorata Flower Extract, Citrus Aurantium Amara (Bitter Orange) Flower Extract, Citrus Auranitum Bergamia(Bergamot) Fruit Extract, Coffea Arabica (Coffee) Seed Extract, Cucumis Melo (Melon) Fruit Extract,Cucumis Sativus (Cucumber) FruitExtract, Cupressus Sempervirens Leaf Extract, Cucumis Melo Cantalupensis Fruit Extract, Jasminum Officinale (Jasmine) Flower Extract,Rose Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Salvia Officinalis (Sage) Leaf Extract, Santalum Album (Sandalwood) WoodExtract, Tocopherol, Glycine Soja Oil, Polyglycerin-3, Stevia Rebaudiana Leaf/Stem Extract, Citric Acid, Linalool, Hydroxycitronellal,Amyl Cinnamal, Citronellol.

Other Information

  • Protect this product frome excessive heat and direct sun.

* Please review the disclaimer below.