NDC 61995-2020 Sport Sunscreen Spf 45

Avobenzone, Homosalate, Octocrylene, Octisalate

NDC Product Code 61995-2020

NDC 61995-2020-4

Package Description: 113 g in 1 TUBE

NDC Product Information

Sport Sunscreen Spf 45 with NDC 61995-2020 is a a human over the counter drug product labeled by The Hain Celestial Group, Inc. The generic name of Sport Sunscreen Spf 45 is avobenzone, homosalate, octocrylene, octisalate. The product's dosage form is lotion and is administered via topical form.

Labeler Name: The Hain Celestial Group, 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 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.

Sport Sunscreen Spf 45 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.

  • HOMOSALATE 10 g/100g
  • OCTOCRYLENE 10 g/100g
  • OCTISALATE 5 g/100g
  • AVOBENZONE 3 g/100g

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.

  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)
  • GINKGO (UNII: 19FUJ2C58T)
  • ASIAN GINSENG (UNII: CUQ3A77YXI)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • ALOE VERA WHOLE (UNII: KIZ4X2EHYX)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • ALCOHOL (UNII: 3K9958V90M)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)

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: The Hain Celestial Group, Inc
Labeler Code: 61995
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: 08-19-2019 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.

Sport Sunscreen Spf 45 Product Label Images

Sport Sunscreen Spf 45 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

Otc - Active Ingredient

Avobenzone 3%Homosalate 10%Octocrylene 10%Octisalate 5%

Dosage & Administration

  • Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours. Children under 6 months: ask a doctor.
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with broad spectrum SPF 15 or higher and other protective measures including:
  • Limit time in the sun, especially from 10am to 2pm and wear long-sleeved shirts, pants, hats and sunglasses.

Otc - Purpose

Sunscreen

Warnings

For external use only. Do not use on broken or damaged skin. When using this product, keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if skin rash occurs. If swallowed, get medical help or contact a Poison Control Center right away.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Inactive Ingredient

Water (Aqua), Cetyl Alcohol, Glycerin, Glyceryl Stearate SE, Dimethicone, Caprylic/Capric Triglyceride, VP/Hexadecene Copolymer, Aloe Barbadensis Leaf Juice (1), Calendula Officinalis Flower Extract (1), Camellia Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Ginkgo Biloba Leaf Extract, Lavandula Angustifolia (Lavender) Flower Extract (1), Panax Ginseng Root Extract, Tocopheryl Acetate, Alcohol (1), Cetearyl Alcohol, Cetearyl Olivate, Citric Acid, Polysorbate 60, Sodium Chloride, Sodium Stearoyl Glutamate, Sorbitan Olivate, Xanthan Gum, Benzyl Alcohol, Potassium Sorbate, Sodium Benzoate (1) Certified Organic Ingredient

Indications & Usage

  • 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

* Please review the disclaimer below.