NDC 75936-210 Everyday Sunscreen With Sunflower Extract Broad Spectrum Spf 30

Avobenzone, Homosalate, Octisalate

NDC Product Code 75936-210

NDC Code: 75936-210

Proprietary Name: Everyday Sunscreen With Sunflower Extract Broad Spectrum Spf 30 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, Octisalate 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

  • 75936 - Taylor James Ltd
    • 75936-210 - Everyday Sunscreen With Sunflower Extract Broad Spectrum Spf 30

NDC 75936-210-01

Package Description: 71 mL in 1 BOTTLE

NDC 75936-210-02

Package Description: 222 mL in 1 BOTTLE

NDC Product Information

Everyday Sunscreen With Sunflower Extract Broad Spectrum Spf 30 with NDC 75936-210 is a a human over the counter drug product labeled by Taylor James Ltd. The generic name of Everyday Sunscreen With Sunflower Extract Broad Spectrum Spf 30 is avobenzone, homosalate, octisalate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Taylor James Ltd

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.

Everyday Sunscreen With Sunflower Extract Broad Spectrum Spf 30 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 3 g/100mL
  • HOMOSALATE 10 g/100mL
  • OCTISALATE 5 g/100mL

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.

  • TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
  • BEHENIC ACID (UNII: H390488X0A)
  • CETYL BEHENATE (UNII: WFM51TRO3E)
  • ISOSTEARYL STEARATE (UNII: E08UTG6X4W)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
  • EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
  • ROSEWOOD OIL (UNII: F2522O5L7B)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • ORANGE OIL (UNII: AKN3KSD11B)
  • LEMON OIL (UNII: I9GRO824LL)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • ALLANTOIN (UNII: 344S277G0Z)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
  • WATER (UNII: 059QF0KO0R)
  • BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
  • DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
  • ISODODECANE (UNII: A8289P68Y2)
  • LAURYL LACTATE (UNII: G5SU0BFK7O)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
  • RICE BRAN (UNII: R60QEP13IC)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)

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: Taylor James Ltd
Labeler Code: 75936
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: 02-12-2019 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.

Everyday Sunscreen With Sunflower Extract Broad Spectrum Spf 30 Product Label Images

Everyday Sunscreen With Sunflower Extract Broad Spectrum Spf 30 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

Active Ingredients PurposeAvobenzone 3% SunscreenHomosalate 10% SunscreenOctisalate 5% Sunscreen

Otc - Purpose

  • UsesHelps prevent sunburnIf used as directed with other sun protection measures (see
  • DIrections), decreases the risk of skin cancer and early skin aging casused by the sun

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.

Indications & Usage

Stop use and ask a doctor if rash occurs.

Warnings

WarningsFor external use only Do not use on damaged or broken skin.
When using this product keep out of eyes. Rinse with water to remove.

Dosage & Administration

  • DirectionsApply gerenously and evenly 15 minutes before sun exsposureReapplyafter 80 minutes of swimming or sweating immediately 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 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 sunglassesChildren under 6 months: Ask a doctor

Inactive Ingredient

Inactive IngredientsWater, Polyester-8, Acrylates Copolymer, Diisopropyl Sebacate, Glycerin, Isodecyl Neopentanoate, Isododecane, Lauryl Lactate, Cetyl Alcohol, Potassium Cetyl Phosphate, Brassica Campstris/Aleurites Fordi Oil Copolymer, Oryza Sativa (Rice) Bran Extract, Cetearyl Olivate, Ammonium Acryloyldimethyltaurate/ VP Copolymer, Hydroxyacetophenone, Sorbitan Olivate, Diethylhexyl Syringylidenemalonate, Aniba Roseodora (Rosewood) Wood Oil, Chlorphenesin, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Limon (Lemon) Peel Oil, Ethyhexylglycerin, Eucaluptyus Globulus Leaf Oil, Ocimum Basilicum (Basil) Flower/Leaf Extract, Pelargonium Graveolens Flower Oil, Pogostemon Cablin Oil, Pentylene Glycol, 1,2-Hexanediol, Caprylyl Glycol, Xanthan Gum, Helianthus Annuus (sunflower) Extract, Behenic Acid, Cetyl Behenate, Isostearyl Isostearate, Trisodium Ethylenediamine Disuccinate, Tocopherol, Allantoin, Rosmarinus Officinialis (Rosemary) Leaf Extract, Caprylic/Capric Triglyceride, Panthenol, Pentasodium Triphosphate, Citric Acid

* Please review the disclaimer below.

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