NDC 61543-0154 Solar Sense Spf 50 Daily Facial Sunscreen

Homosalate, Octocrylene, Octisalate, Avobenzone

NDC Product Code 61543-0154

NDC CODE: 61543-0154

Proprietary Name: Solar Sense Spf 50 Daily Facial Sunscreen 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: Homosalate, Octocrylene, Octisalate, Avobenzone 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

  • 61543 - Cca Industries, Inc
    • 61543-0154 - Solar Sense Spf 50 Daily Facial Sunscreen

NDC 61543-0154-1

Package Description: 1 TUBE in 1 CARTON > 50 mL in 1 TUBE

NDC Product Information

Solar Sense Spf 50 Daily Facial Sunscreen with NDC 61543-0154 is a a human over the counter drug product labeled by Cca Industries, Inc. The generic name of Solar Sense Spf 50 Daily Facial Sunscreen is homosalate, octocrylene, octisalate, avobenzone. The product's dosage form is cream and is administered via topical form.

Labeler Name: Cca Industries, Inc

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Solar Sense Spf 50 Daily Facial Sunscreen 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 100 mg/mL
  • OCTOCRYLENE 100 mg/mL
  • OCTISALATE 50 mg/mL
  • AVOBENZONE 30 mg/mL

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)
  • WATER (UNII: 059QF0KO0R)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • CUCUMBER SEED (UNII: BT3S9L53JK)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • CYCLOMETHICONE 4 (UNII: CZ227117JE)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • LAURETH-7 (UNII: Z95S6G8201)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • CORN (UNII: 0N8672707O)

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: Cca Industries, Inc
Labeler Code: 61543
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: 07-08-2020 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 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.

Solar Sense Spf 50 Daily Facial Sunscreen Product Label Images

Solar Sense Spf 50 Daily Facial Sunscreen 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

Homosalate 10.0%Octocrylene 10.0%Octisalate 5.0%Avobenzone 3.0%

Purpose

Sunscreen

Uses

• Helps prevent sunburn • If used as directed with other sun protection measure (see directions), decreases the risk of skin cancer and early skin aging caused by the sun• Higher SPF gives more sunburn protection.

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 Consult Physician If

• irritation or rash developes and lasts.

Keep Out Of Reach Of Children.

If product is swallowed, get medical attention or contact poison control center immediately.

Directions

• Apply liberally 15-minutes before sun exposure REAPPLY: At least every two-hours immediately after swimming, sweating or towel drying 


•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 sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including:• Limit time in the sun, especially between 10am - 2pm• Wear long sleeve shirts, pants, hats and sunglasses.

Inactive Ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Extract, Cetearyl Alcohol, Cetearyl Olivate, Cocamidopropyl Betaine, Cucumis Sativus (Cucumber) Extract, Cyclopentasiloxane, Cyclotetrasiloxane, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, C13-14 Isoparaffin, Isopropyl Myristate, Laureth-7,


Parfum (Fragrance), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Polysorbate-20, Punica Granatum (Pomegranate) Extract, Sorbitan Olivate, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol.

Other Information

Protect this product from excessive heat and direct sunlight.

Questions?

Call 1-800-595-6230 or visit www.solarsensespf.com

* Please review the disclaimer below.