NDC 13630-0116 Soleil Toujours Spf 50 Sheer Sunscreen Mist

Avobenzone, Homosalate, Octisalate

NDC Product Code 13630-0116

NDC 13630-0116-4

Package Description: 177 mL in 1 CAN

NDC Product Information

Soleil Toujours Spf 50 Sheer Sunscreen Mist with NDC 13630-0116 is a a human over the counter drug product labeled by Prime Packaging Inc.. The generic name of Soleil Toujours Spf 50 Sheer Sunscreen Mist is avobenzone, homosalate, octisalate. The product's dosage form is spray and is administered via topical form.

Labeler Name: Prime Packaging Inc.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Soleil Toujours Spf 50 Sheer Sunscreen Mist 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 25.17 mg/mL
  • HOMOSALATE 62.93 mg/mL
  • OCTISALATE 41.95 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.

  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CUCUMBER (UNII: YY7C30VXJT)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • JASMINUM SAMBAC WHOLE (UNII: 1Z81V275I0)
  • ISOBUTYL ACETATE (UNII: 7CR47FO6LF)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • ALCOHOL (UNII: 3K9958V90M)
  • DIBUTYL MALEATE (UNII: 4X371TMK9K)
  • OPOPANAX RESIN (UNII: TA8L57B94W)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • BERGAMOT OIL (UNII: 39W1PKE3JI)
  • PIPERONAL (UNII: KE109YAK00)
  • ISOAMYL ACETATE (UNII: Z135787824)
  • POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
  • TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
  • PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)
  • WATER (UNII: 059QF0KO0R)
  • DAVANA OIL (UNII: CL439Y041G)
  • LEMON OIL (UNII: I9GRO824LL)
  • LIME OIL (UNII: UZH29XGA8G)
  • CITRUS NOBILIS WHOLE (UNII: U29I7N5FLM)
  • ETHYL ACETOACETATE (UNII: IZP61H3TB1)
  • .GAMMA.-UNDECALACTONE (UNII: QB1T0AG2YL)
  • ETHYL ACETATE (UNII: 76845O8NMZ)
  • GALBANUM OIL (UNII: 211UF7M8N1)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • TRICAPRYLIN (UNII: 6P92858988)
  • ORANGE OIL TERPENELESS (UNII: L8B7EWV9I7)
  • CLARY SAGE OIL (UNII: 87L0D4U3M0)

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: Prime Packaging Inc.
Labeler Code: 13630
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: 08-17-2016 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.

Soleil Toujours Spf 50 Sheer Sunscreen Mist Product Label Images

Soleil Toujours Spf 50 Sheer Sunscreen Mist 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%Homosalate 7.5%Octisalate 5%

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.

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. Keep away from face to avoid breathing it
Contents under pressure - do not puncture or incinerate. Do not store at temperatures above 120°F.

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 product is swallowed, get medical help or contact a Poison Control Center right away.

Other

Flammable:
Do not use near heat, flame or while smoking.

Directions

  • Shake wellspray liberally and spread evenly by hand 15 minutes before sun exposurehold container 4 to 6 inches from the skin to applydo not spray directly into face. Spray on hands then apply to facedo not apply in windy conditionsuse in a well-ventilated areareapply:after 80 minutes of swimming or sweatingimmediately after towel dryingat least every 2 hoursSun 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 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-sleeve shirts, pants, hats, and sunglasseschildren under 6 months: Ask a doctor

Inactive Ingredient

Aloe Barbadensis Leaf Juice, Artemesia pallens Flower Oil, Ascorbyl Palmitate, Bisabolol, Camellia Oleifera (Green Tea) Leaf Extract, Caprylic/Capric Triglyceride, Citrus aurantifolia Peel Oil, Citrus aurantium bergamia Fruit Extract, Citrus limon Peel Oil, Citrus nobilis Flower Oil, Citrus sinensis Peel Oil, Cucumis Sativus (Cucumber) Extract, Ethyl Acetate, Ethyl Acetoacetate, Ferula galbaniflua Resin Oil, Gamma Undecalactone, Glycerin, Heliotropine, Isoamyl Acetate, Isobutyl Acetate, Jasminum sambac Oil, Opoponax Oil, Polyester-8, Porphyra Umbilicalis Extract, Salvia sclarea Oil, SD Alcohol 40-B, Sodium Hyaluronate, Tetrahexyldecyl Ascorbate, Tocopherol, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water

Other Information

  • Protect this product from excessive heat and direct sunavoid spraying on fabrics - could cause discoloration

* Please review the disclaimer below.