Soothe And Hydrate Starter Set
Avobenzone, Octinoxate, And Octocrylene
Acheson & Acheson Ltd.
Human Otc Drug
NDC 69378-009Soothe And Hydrate Starter Set also known as Avobenzone, Octinoxate, And Octocrylene is a human otc drug labeled by 'Acheson & Acheson Ltd.'. National Drug Code (NDC) number for Soothe And Hydrate Starter Set is 69378-009. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Soothe And Hydrate Starter Set drug includes . The currest status of Soothe And Hydrate Starter Set drug is Active.
Drug Information:
| Drug NDC: | 69378-009 |
| 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: | Soothe And Hydrate Starter Set |
| 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, Octinoxate, And Octocrylene |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Acheson & Acheson Ltd. |
| 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: | TOPICAL
|
| 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 Oct, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jan, 2025 |
| 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, 2023 |
| 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: | Acheson & Acheson Ltd.
|
| 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 |
|---|
| 69378-009-01 | 1 BOX in 1 CONTAINER (69378-009-01) / 1 KIT in 1 BOX * 15 g in 1 TUBE (69378-001-16) * 2 GEL in 1 CONTAINER | 01 Oct, 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
Product Elements:
Soothe and hydrate starter set avobenzone, octinoxate, and octocrylene pro-collagen energising marine cleanser cocamidopropyl betaine euterpe oleracea whole rosa damascena flower sodium hydroxide magnesium aspartate zinc gluconate padina pavonica lactobacillus fermentum leuconostoc/radish root ferment filtrate lauryl glucoside xanthan gum phenoxyethanol chlorphenesin sodium chloride sea salt glycerin pyrrolidone carboxylic acid rhizobian gum edetate disodium anhydrous hyaluronate sodium mimosa tenuiflora bark guar hydroxypropyltrimonium chloride (1.7 substituents per saccharide) succinic acid lactic acid water sodium lauroyl sarcosinate copper gluconate pro-collagen marine broad spectrum spf 30 avobenzone, octinoxate, and octocrylene polysorbate 20 sorbitan isostearate ginkgo acacia decurrens flower porphyridium purpureum phenoxyethanol cetyl alcohol polyisobutylene (1000 mw) xanthan gum chlorphenesin lecithin, soybean chlorella vulgaris padina pavonica dimethicone butylene glycol hydroxyacetophenone stearic acid .alpha.-tocopherol acetate coco-caprylate shea butter dicaprylyl carbonate rosa centifolia flower sodium benzoate potassium sorbate glycerin water medium-chain triglycerides glyceryl stearate se isononyl isononanoate edetate disodium anhydrous tocopherol carrot wheat germ oil citric acid monohydrate sodium dehydroacetate octocrylene octocrylene octinoxate octinoxate avobenzone avobenzone soothing apricot toner glycerin sodium dehydroacetate water methyl gluceth-20 edetate disodium anhydrous chlorphenesin tromethamine saponaria officinalis leaf apricot polysorbate 20 potassium sorbate sodium benzoate phenoxyethanol quillaja saponaria saponins fraction a pro-collagen hydra-gel eye masks panthenol chlorella vulgaris green tea leaf citrus junos fruit glycerin padina pavonica sodium chloride ethylhexylglycerin hyaluronate sodium caprylyl glycol phenoxyethanol castor oil jojoba oil edetate disodium anhydrous butylene glycol locust bean gum 1,2-hexanediol carrageenan potassium hydroxide scutellaria baicalensis root artemisia princeps leaf peg-60 hydrogenated castor oil water pro-collagen marine moisture essence sorbitan isostearate peg-60 hydrogenated castor oil potassium sorbate ammonium acryloyldimethyltaurate, dimethylacrylamide, lauryl methacrylate and laureth-4 methacrylate copolymer, trimethylolpropane triacrylate crosslinked (45000 mpa.s) water tocopherol sodium acetylated hyaluronate edetate disodium anhydrous tert-butyl alcohol magnesium aspartate glycerin sodium benzoate padina pavonica rosa centifolia flower zinc gluconate phenoxyethanol leuconostoc/radish root ferment filtrate sodium hydroxide chlorella vulgaris trideceth-9 sodium chloride lactobionic acid polysorbate 60 mimosa tenuiflora bark citric acid monohydrate sunflower oil propylene glycol copper gluconate
Indications and Usage:
Uses helps prevent sunburn higher spf gives more sunburn protection
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 rash occurs keep ou1 of reach of children. if swallowed, get medical help or contact a poison control center right away.
Dosage and Administration:
Directions apply liberally and evenly 15 minutes before sun exposure and as needed children under 6 months of age: ask a doctor sun protection measures.s pending time in the sun increases your risk of skin cancer and early skin ageing, to decrease this risk, regularly use a sunscreen with a broad spectrums pf value of 15 or higher and other sun protection measures including· limit time in the sun, especially from 1 0a.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:
Elemis london soothe & hydrate starter set skin soothing & deeply hydrating favourites pro-collagen energising marine cleanser 150ml e 5.0 us fl.oz. i soothing apricot toner 50ml e 1.6 us fl.oz. pro-collagen marine moisture essence 28ml e 0.9 us fl.oz. i pro-collagen hydra-gel eye masks 1 x pair pro-collagenmarine cream spf 30 15ml e 0.5 us. fl.oz. ? pdp
Further Questions:
Questions? ust: 1-855-235-3647