NDC 75936-215 Everyday Sunscreen Spf 50 With Sunflower Extract

Avobenzone, Homosalate, Octinoxate, Octisalate

NDC Product Code 75936-215

NDC Code: 75936-215

Proprietary Name: Everyday Sunscreen Spf 50 With Sunflower Extract 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, Octinoxate, 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
    • 75936-215 - Everyday Sunscreen Spf 50 With Sunflower Extract

NDC 75936-215-01

Package Description: 532 mL in 1 BOTTLE

NDC 75936-215-02

Package Description: 222 mL in 1 BOTTLE

NDC 75936-215-03

Package Description: 71 mL in 1 BOTTLE

NDC 75936-215-04

Package Description: 30 mL in 1 BOTTLE

NDC 75936-215-05

Package Description: 10 mL in 1 BOTTLE

NDC 75936-215-06

Package Description: 3 mL in 1 BOTTLE

NDC Product Information

Everyday Sunscreen Spf 50 With Sunflower Extract with NDC 75936-215 is a a human over the counter drug product labeled by Taylor James. The generic name of Everyday Sunscreen Spf 50 With Sunflower Extract is avobenzone, homosalate, octinoxate, octisalate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Taylor James

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 Spf 50 With Sunflower Extract 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.

  • OCTINOXATE 7.5 g/100mL
  • OCTISALATE 5 g/100mL
  • AVOBENZONE 3 g/100mL
  • HOMOSALATE 10 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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • ALLANTOIN (UNII: 344S277G0Z)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • RICE BRAN (UNII: R60QEP13IC)
  • ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
  • LAURYL LACTATE (UNII: G5SU0BFK7O)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CETYL BEHENATE (UNII: WFM51TRO3E)
  • ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
  • LEMON OIL (UNII: I9GRO824LL)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • ROSEMARY (UNII: IJ67X351P9)
  • ISODODECANE (UNII: A8289P68Y2)
  • POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
  • POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
  • DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
  • HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
  • ROSEWOOD OIL (UNII: F2522O5L7B)
  • ORANGE OIL (UNII: AKN3KSD11B)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • PATCHOULI OIL (UNII: F3IN55X5PO)
  • BEHENIC ACID (UNII: H390488X0A)

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
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: 02-19-2019 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.

Everyday Sunscreen Spf 50 With Sunflower Extract 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% SunscreenOctinoxate 7.5% SunscreenOctisalate 5% Sunscree

Otc - Purpose

  • 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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If 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 onlyDo not use on damaged or broken skinWhen using this product, Keep out of eyes. Rinse with water to remove

Dosage & Administration

DirectionsApply liberally 15 minutes before sun exposureReapply:after 80 minutes of swimming or sweating

immediately after towel drying

at least every 2 hours

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 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-sleeved shirts, pants, hats, and sunglasses

Children under 6 months: Ask a doctor

Inactive Ingredient

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

* Please review the disclaimer below.

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