NDC 68828-444 Tender Moments Baby Sunscreen Broad Spectrum Spf 50 Water Resistant (40 Minutes)

Avobenzone, Homosalate, Octisalate, Octocrylene

NDC Product Code 68828-444

NDC CODE: 68828-444

Proprietary Name: Tender Moments Baby Sunscreen Broad Spectrum Spf 50 Water Resistant (40 Minutes) 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, Octocrylene 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

  • 68828 - Jafra Cosmetics International

NDC 68828-444-01

Package Description: 50 mL in 1 BOTTLE

NDC 68828-444-02

Package Description: 7.5 mL in 1 TUBE

NDC Product Information

Tender Moments Baby Sunscreen Broad Spectrum Spf 50 Water Resistant (40 Minutes) with NDC 68828-444 is a a human over the counter drug product labeled by Jafra Cosmetics International. The generic name of Tender Moments Baby Sunscreen Broad Spectrum Spf 50 Water Resistant (40 Minutes) is avobenzone, homosalate, octisalate, octocrylene. The product's dosage form is cream and is administered via topical form.

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.

Tender Moments Baby Sunscreen Broad Spectrum Spf 50 Water Resistant (40 Minutes) 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.


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.

  • POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
  • VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • MICA (UNII: V8A1AW0880)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • WATER (UNII: 059QF0KO0R)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
  • ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • ARGININE (UNII: 94ZLA3W45F)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • GLYCERIN (UNII: PDC6A3C0OX)

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: Jafra Cosmetics International
Labeler Code: 68828
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: 06-10-2021 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: 12-31-2022 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 - NO 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".

* Please review the disclaimer below.

Tender Moments Baby Sunscreen Broad Spectrum Spf 50 Water Resistant (40 Minutes) Product Label Images

Tender Moments Baby Sunscreen Broad Spectrum Spf 50 Water Resistant (40 Minutes) 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% SunscreenOctocrylene 10% Sunscreen

Otc - Purpose

UsesHelps 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.

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

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

Dosage & Administration

  • Directionsapply liberally 15 minutes before sun exposurereapply:after 40 minutes of swimming or sweatingimmediately after towel dryingat least every 2 hourschildren under 6 months: Ask a doctorSun 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

Inactive Ingredient

Inactive ingredientsWater/Aqua, Glycerin, Polyester-8, Glyceryl Stearate, PEG-100 Stearate, Styrene/Acrylates Copolymer, Cetyl Alcohol, Dicaprylyl Carbonate, VP/Eicosene Copolymer, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Ethylhexyl Methoxycrylene, Mica/CI 77019, Silica, Bisabolol, Butyrospermum Parkii (Shea) Butter, Aloe Barbadensis Leaf Juice, Arginine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Panthenol, Tocopheryl Acetate, Chlorphenesin, Disodium EDTA

Other Safety Information

Other informationprotect this product from excessive heat and direct sun

* Please review the disclaimer below.