NDC 75936-123 Sunscreen Mist Broad Spectrum Spf 30 Supergoop
Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene Spray Topical

Product Information

Product Code75936-123
Proprietary Name 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.
Sunscreen Mist Broad Spectrum Spf 30 Supergoop
Non-Proprietary Name 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.
Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene
Product Type 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.
Human Otc Drug
Dosage FormSpray - A liquid minutely divided as by a jet of air or steam.
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.
Taylor James, Ltd.
Labeler Code75936
FDA Application Number 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.
part352
Marketing Category 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.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
01-07-2013
Listing Expiration Date 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.
12-31-2022
Exclude Flag 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".
N
NDC Code Structure

Usage Information


Product Packages

NDC 75936-123-01

Package Description: 177 mL in 1 CAN

NDC 75936-123-03

Package Description: 1 CAN in 1 PACKAGE > 89 mL in 1 CAN (75936-123-02)

Product Details

Sunscreen Mist Broad Spectrum Spf 30 Supergoop is a human over the counter drug product labeled by Taylor James, Ltd.. The generic name of Sunscreen Mist Broad Spectrum Spf 30 Supergoop is avobenzone, homosalate, octinoxate, octisalate, octocrylene. The product's dosage form is spray and is administered via topical form.


What are Sunscreen Mist Broad Spectrum Spf 30 Supergoop Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


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.

  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • CANANGA OIL (UNII: 8YOY78GNNX)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • LIME OIL (UNII: UZH29XGA8G)
  • CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)
  • CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED)
  • MANDARIN OIL (UNII: NJO720F72R)
  • ORANGE OIL TERPENELESS (UNII: L8B7EWV9I7)
  • DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
  • DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
  • ACAI (UNII: 46AM2VJ0AW)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • SPEARMINT OIL (UNII: C3M81465G5)
  • TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
  • TRIDECYL NEOPENTANOATE (UNII: 3Z8H1DA7J5)
  • GRAPE SEED OIL (UNII: 930MLC8XGG)


* Please review the disclaimer below.

Sunscreen Mist Broad Spectrum Spf 30 Supergoop Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Otc - Active Ingredient



Active Ingredients Purpose

Avobenzone 3% Sunscreen

Homosalate 10% Sunscreen

Octinoxate 7.5% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 10% Sunscreen


Otc - Purpose



Uses

Helps Prevent Sunburn

If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Indications & Usage



Stop use and ask a doctor if rash occurs


Warnings



Warnings Flamamble. Keep away from flames and sparks

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

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


Dosage & Administration



Directions Apply Liberally 15 minutes before sun exposure

Reapply: after 80 minutes of swimming or sweating

immediately after towel drying

at least every 2 hours when exposed to sunlight

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 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.-2p.m.

wear long-sleved shirts, pants, hats, and sunglasses


Inactive Ingredient



Inactive Ingredients Alcohol Denat, Camellia Sinensis Leaf Extract, Cananga Odorata Flower Oil, Caprylic/Capric Triglyceride, Citrus Aurantifolia (Lime) Oil, Citrus Grandis (Grapefruit) Peel Oil, Citrus Limon Fruit Oil, Citrus Nobilis (Mandarin Orange) Peel Oil, Citrus Reticulata (Tangerine) Peel Oil, Citrus Sinensis Peel Oil, Dicaprylyl Carbonate, Diisopropyl Adipate, Euterpe Oleracea Fruit Extract, Helianthus Annuus (Sunflower) Seed Oil, Isodecyl Neoppentanoate, Lavandula Angustifolia (lavender) Oil, Mentha Piperita (Peppermint Oil) Mentha Viridis (Spearmint) Leaf Oil, Tetrahexyldecyl Ascorbate (Vitamin C), Tridecyl Neopentanoate, VA/Butyl Maleate/Isobornyl Acrylate Coploymer, Vitis Vinifera (Grape) Seed Oil.


Package Label.Principal Display Panel



Supergoop! Antioxidant-infused

Sunscreen Mist

with Vitamin C

Broad Spectrum SPF 30

Water resistant (80 minutes)

apply to wet or dry skin

Twist-lock cap

6 fl. oz./177 ml


* Please review the disclaimer below.