NDC 51060-242 Hello, Sunshine Moisturizer Broad Spectrum Spf 30 Sunscreen
Homosalate, Oxybenzone, Octisalate, Avobenzone, And Octocrylene Liquid Topical

Product Information

Product Code51060-242
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.
Hello, Sunshine Moisturizer Broad Spectrum Spf 30 Sunscreen
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.
Homosalate, Oxybenzone, Octisalate, Avobenzone, And 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 FormLiquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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.
Tarte, Inc.
Labeler Code51060
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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
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.
07-06-2017
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 51060-242-01

Package Description: 1 JAR in 1 CARTON > 50 mL in 1 JAR

Product Details

Hello, Sunshine Moisturizer Broad Spectrum Spf 30 Sunscreen is a human over the counter drug product labeled by Tarte, Inc.. The generic name of Hello, Sunshine Moisturizer Broad Spectrum Spf 30 Sunscreen is homosalate, oxybenzone, octisalate, avobenzone, and octocrylene. The product's dosage form is liquid and is administered via topical form.


What are Hello, Sunshine Moisturizer Broad Spectrum Spf 30 Sunscreen 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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • SQUALANE (UNII: GW89575KF9)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • BETASIZOFIRAN (UNII: 2X51AD1X3T)
  • PHENYLETHYL RESORCINOL (UNII: G37UFG162O)
  • TRIBEHENIN (UNII: 8OC9U7TQZ0)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • ALLANTOIN (UNII: 344S277G0Z)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • CERAMIDE NG (UNII: C04977SRJ5)
  • SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
  • SOYBEAN OIL (UNII: 241ATL177A)
  • HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
  • SODIUM OLEATE (UNII: 399SL044HN)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • CITRAL (UNII: T7EU0O9VPP)
  • SODIUM CARBONATE (UNII: 45P3261C7T)
  • ORANGE OIL (UNII: AKN3KSD11B)
  • .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
  • GERANIOL (UNII: L837108USY)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)
  • FARNESOL (UNII: EB41QIU6JL)
  • MICA (UNII: V8A1AW0880)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)


* Please review the disclaimer below.

Hello, Sunshine Moisturizer Broad Spectrum Spf 30 Sunscreen 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



Other



Drug Facts

Dist. By Awake Beauty, Inc. New York, NY 10018.


Active Ingredients



Homosalate 10.00%, Oxybenzone 5.00%, Octisalate 5.00%, Avobenzone 3.00%, Octocrylene 1.00%


Purpose



Sunscreen


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.

Warnings



For external use only.


Otc - Stop Use



Stop use and ask doctor if rash occurs.


Otc - Do Not Use



Do not use on damaged or broken skin.


Otc - When Using



When using this product keep out of eyes. Rinse with water to remove.


Otc - Keep Out Of Reach Of Children



Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • Apply liberally 15 minutes before sun exposure.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • Children under 6 months: Ask a doctor.
  • Apply to all skin exposed to the sun.
  • 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.-2 p.m.
    • –Wear long-sleeved shirts, pants, hats and sunglasses

Other Information



  • Protect the product in this container from excessive heat and direct sunlight.
  • You may report a serious adverse reaction to: Awake Beauty c/o Report Reaction, LLC, P.O. Box 22, Plainsboro, New Jersey 08536-0222.

Inactive Ingredients



Water, glyceryl stearate, glycerin, propanediol, cetearyl alcohol, squalene, stearic acid, C12-15 alkyl benzoate, butylene glycol, dimethicone, polyester-8, polysorbate 60, potassium cetyl phosphate, helianthus annuus (sunflower) seed oil, citrus aurantium dulcis (orange) oil, phenoxyethanol, sclerotium gum, phenylethyl resorcinol, tribehenin, dimethiconol, caprylyl glycol, chlorphenesin, allantoin, tocopheryl acetate, disodium EDTA, sodium hydroxide, ceramide NG, PEG-10 phytosterol, sodium PCA, glycine soja (soybean) oil, hydrogenated lecithin, oligopeptide-68, sodium oleate, linalool, citral, sodium carbonate, limonene, tocopherol, palmitoyl hexapeptide-12, mica, titanium dioxide, iron oxides. OX100AWFZ000022.


Principal Display Panel - 50 Ml Jar Carton



Awake

Hello, Sunshine
moisturizer
Broad Spectrum SPF 30
sunscreen

net 50 mL / 1.70 Fl. Oz.


* Please review the disclaimer below.