Day In The Sun Kit
Avobenzone,homosalate,octisalate,octocrylene
The Wonderful Group Llc
Human Otc Drug
NDC 80782-001Day In The Sun Kit also known as Avobenzone,homosalate,octisalate,octocrylene is a human otc drug labeled by 'The Wonderful Group Llc'. National Drug Code (NDC) number for Day In The Sun Kit is 80782-001. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Day In The Sun Kit drug includes . The currest status of Day In The Sun Kit drug is Active.
Drug Information:
| Drug NDC: | 80782-001 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Day In The Sun Kit |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Avobenzone,homosalate,octisalate,octocrylene |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | The Wonderful Group Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 01 Aug, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 Jun, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part352 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2024 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | THE WONDERFUL GROUP LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | |
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 80782-001-01 | 1 KIT in 1 KIT (80782-001-01) * 75 mL in 1 BOTTLE * 75 mL in 1 BOTTLE * 4.5 g in 1 TUBE (80782-004-01) * 50 mL in 1 JAR (80782-003-01) * 75 mL in 1 TUBE (80782-002-01) | 01 Aug, 2021 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose sunscreen
Purpose sunscreen
Purpose sunscreen
Product Elements:
Day in the sun kit avobenzone,homosalate,octisalate,octocrylene sunscreen broad spectrum spf 30 avobenzone,homosalate,octisalate,octocrylene water butylene glycol dicaprylate/dicaprate butyloctyl salicylate propylene glycol peg-100 stearate vinylpyrrolidone/eicosene copolymer butyl acrylate/methyl methacrylate/methacrylic acid copolymer (18000 mw) steareth-20 glyceryl monostearate steareth-2 phenoxyethanol ethylhexylglycerin carbomer interpolymer type a (allyl sucrose crosslinked) edetate disodium anhydrous hyaluronate sodium sodium hydroxide avobenzone avobenzone homosalate homosalate octisalate octisalate octocrylene octocrylene sunscreen moisturizing face broad spectrum spf 40 avobenzone,homosalate,octisalate,octocrylene water grape seed oil butyloctyl salicylate coconut oil glyceryl monostearate aloe vera leaf vinylpyrrolidone/eicosene copolymer cetostearyl alcohol trehalose sodium pyrrolidone carboxylate prunus persica twig dendrobium moniliforme whole tremella fuciformis fruiting body cistanche deserticola stem phenoxyethanol ethylhexylglycerin carbomer interpolymer type a (allyl sucrose crosslinked) hyaluronate sodium .alpha.-tocopherol acetate butylene glycol dicaprylate/dicaprate butyl acrylate/methyl methacrylate/methacrylic acid copolymer (18000 mw) steareth-20 steareth-2 sodium hydroxide avobenzone avobenzone homosalate homosalate octisalate octisalate octocrylene octocrylene sunscreen lip balm broad spectrum spf 30 avobenzone,homosalate,octisalate,octocrylene ethylhexyl palmitate medium-chain triglycerides sodium dichloroacetate microcrystalline wax canola oil hydrogenated soybean oil olive oil butyrospermum parkii (shea) butter unsaponifiables vinylpyrrolidone/eicosene copolymer avobenzone avobenzone homosalate homosalate octisalate octisalate octocrylene octocrylene aloe gel aftersun lotion
Indications and Usage:
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
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 sunâ
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:
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. stop use and ask a doctor if irritation or rash develops keep out of reach of children . if product is swallowed, get medical attention or contact poison control center immediately.
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. stop use and ask a doctor if irritation or rash develops keep out of reach of children . if a product is swallowed, get medical attention or contact a poison control center immediately.
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. stop use and ask a doctor if irritation or rash develops keep out of reach of children. if product is swallowed, get medical attention or contact poison control center immediately.
Dosage and Administration:
Directions apply liberally and evenly 15 minutes before sun exposure children under 6 months of age: ask a doctor 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 reapply at least every 2 hours use a water-resistant sunscreen if swimming or sweating
Directions apply liberally and evenly 15 minutes before sun exposure children under 6 months of age: ask a doctor 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 reapply at least every 2 hours use a water-resistant sunscreen if swimming or sweating
Directions apply liberally and evenly 15 minutes before sun exposure children under 6 months of age: ask a doctor 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 reapply at least every 2 hours use a water-resistant sunscreen if swimming or sweating
Package Label Principal Display Panel:
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