NDC 73054-105 Solara Suncare - Time Traveler Spf-30 Unscented

Zinc Oxide

NDC Product Code 73054-105

NDC Code: 73054-105

Proprietary Name: Solara Suncare - Time Traveler Spf-30 Unscented 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: Zinc Oxide 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

  • 73054 - Solara Suncare, Inc.
    • 73054-105 - Solara Suncare - Time Traveler

NDC 73054-105-11

Package Description: 1 TUBE in 1 BOX > 50 mL in 1 TUBE (73054-105-01)

NDC Product Information

Solara Suncare - Time Traveler Spf-30 Unscented with NDC 73054-105 is a a human over the counter drug product labeled by Solara Suncare, Inc.. The generic name of Solara Suncare - Time Traveler Spf-30 Unscented is zinc oxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Solara Suncare, Inc.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Solara Suncare - Time Traveler Spf-30 Unscented 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.

  • ZINC OXIDE 20 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)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • C13-15 ALKANE (UNII: 114P5I43UJ)
  • POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • COCO-CAPRYLATE (UNII: 4828G836N6)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
  • MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)
  • PREZATIDE COPPER (UNII: 6BJQ43T1I9)
  • ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
  • CERAMIDE NG (UNII: C04977SRJ5)
  • HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
  • SQUALANE (UNII: GW89575KF9)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)
  • PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
  • PUNICA GRANATUM FLOWER (UNII: D9B634V4GP)
  • OAT (UNII: Z6J799EAJK)
  • GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)
  • RUBUS IDAEUS LEAF (UNII: 8O2V33JG64)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • KAKADU PLUM (UNII: 0ZQ1D2FDLI)
  • POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • CETYL PALMITATE (UNII: 5ZA2S6B08X)
  • SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • PHENYLPROPANOL (UNII: 0F897O3O4M)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • ISOSTEARIC ACID (UNII: X33R8U0062)
  • LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
  • FRUCTOSE (UNII: 6YSS42VSEV)

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: Solara Suncare, Inc.
Labeler Code: 73054
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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 07-06-2019 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.

Solara Suncare - Time Traveler Spf-30 Unscented Product Label Images

Solara Suncare - Time Traveler Spf-30 Unscented 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

Non-Nano, Non-Coated Zinc Oxide 20%

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 onlyDo not use on damaged or broken skinWhen using this product keep out of eyes. Rinse with water to remove.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 Poison Control Center right away.

Directions

  • Shake or knead before each useapply generously and evenly 15 minutes before sun exposurereapply:after 40 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 the risk, regularly use asunscreen 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-sleeve shirts, pants, hats, and sunglasseschildren under 6 months: Ask a doctor

Inactive Ingredients

Water (Aqua), Caprylic/Capric Triglyceride, Glycerin, C13-14 Alkane, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Butyrospermum Parkii (Shea) Butter, Coco-Caprylate, Propanediol, Cocos Nucifera (Coconut) Oil, Hydrogenated Castor Oil, Magnesium Sulfate, Copper Tripeptide-1, Acetyl Heptapeptide-4, Ceramide Ng, Helianthus Annuus (Sunflower) Seed Wax, Squalane, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Withania Somnifera (Ashwagandha) RootExtract, Perilla Frutescens (Mint) Leaf Extract, Punica Granatum Flower Extract, Avena Sativa (Oat) Kernel Extract, Gardenia Taitensis (Tahitian Gardenia) Flower Extract, Rubus Idaeus Leaf Extract, Potassium Sorbate, Terminalia FerdinandianaFruit Extract, Caprylyl Glycol, Phenylpropanol, Sorbitan Olivate, Isostearic Acid, Lecithin, Cetyl Palmitate, Sorbitan Palmitate, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Fructose

Other Information

  • Protect this product from excessive heat and direct sun.

* Please review the disclaimer below.

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