NDC 75936-252 Sunnyscreen Spf 50

Titanium Dioxide, Zinc Oxide

NDC Product Code 75936-252

NDC Product Information

Sunnyscreen Spf 50 with NDC 75936-252 is a a human over the counter drug product labeled by Taylor James, Ltd.. The generic name of Sunnyscreen Spf 50 is titanium dioxide, zinc oxide. The product's dosage form is spray and is administered via topical form.

Labeler Name: Taylor James, Ltd.

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

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


Sunnyscreen Spf 50 Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • TITANIUM DIOXIDE 10 g/100mL
  • ZINC OXIDE 12 g/100mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • WATER (UNII: 059QF0KO0R)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 04-02-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Sunnyscreen Spf 50 Product Label Images

Sunnyscreen Spf 50 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 Ingredient PurposeTitanium Dioxide 10% SunscreenZinc Oxide 12% 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 caused by the sun.

Otc - Keep Out Of Reach Of Children

Keep out of reach of childrenIf 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

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.

Dosage & Administration

  • DirectionsApply generously and evenly 15 minutes before sun exposureReapply:after 80 minutes of swimming or sweating • immediately after towel dryingat 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 a Broad Spectrum SPF value of 15 or higher and other sun
  • Protection measures including: • limit your time in the sun, especially from 10
  • A.m. – 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses
  • Children under 6 months of age: ask a doctor.

Inactive Ingredient

Inactive IngredientsAqua (Deionized water), Ascorbyl Palmitate, Butyloctyl Salicylate, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Capryl/Caprylyl Glucoside, Chamomilla Recutita (Chamomile) Extract, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Glycerin, Glyceryl Caprylate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Mangifera Indica (Mango) Butter, Polyhydroxystearic Acid, Punica Granatum (Pomegranate) Extract, Stearic Acid, Tocopherol (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol.

* Please review the disclaimer below.

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