Daywear Multi-protection Antii-oxidant 24h-moisture Creme Broad Spectrum Spf 15 Normal/combination Skin
Avobenzone And Octisalate
Estee Lauder Inc
Human Otc Drug
NDC 11559-049Daywear Multi-protection Antii-oxidant 24h-moisture Creme Broad Spectrum Spf 15 Normal/combination Skin also known as Avobenzone And Octisalate is a human otc drug labeled by 'Estee Lauder Inc'. National Drug Code (NDC) number for Daywear Multi-protection Antii-oxidant 24h-moisture Creme Broad Spectrum Spf 15 Normal/combination Skin is 11559-049. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Daywear Multi-protection Antii-oxidant 24h-moisture Creme Broad Spectrum Spf 15 Normal/combination Skin drug includes Avobenzone - 30 mg/mL Octisalate - 50 mg/mL . The currest status of Daywear Multi-protection Antii-oxidant 24h-moisture Creme Broad Spectrum Spf 15 Normal/combination Skin drug is Active.
Drug Information:
| Drug NDC: | 11559-049 |
| 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: | Daywear Multi-protection Antii-oxidant 24h-moisture Creme Broad Spectrum Spf 15 Normal/combination Skin |
| 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 And Octisalate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Estee Lauder Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| 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: | AVOBENZONE - 30 mg/mL
OCTISALATE - 50 mg/mL
|
| 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 Dec, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 Dec, 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: | M020 |
| 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: | ESTEE LAUDER INC
|
| 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: | G63QQF2NOX
4X49Y0596W
|
| 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 |
|---|
| 11559-049-01 | 1 JAR in 1 CARTON (11559-049-01) / 50 mL in 1 JAR | 01 Dec, 2017 | N/A | No |
| 11559-049-02 | 1 JAR in 1 CARTON (11559-049-02) / 15 mL in 1 JAR | 01 Dec, 2022 | N/A | No |
| 11559-049-03 | 30 mL in 1 JAR (11559-049-03) | 01 Dec, 2022 | 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:
Active ingredients purpose avobenzone 3.00% sunscreen octisalate 5.00% sunscreen
Product Elements:
Daywear multi-protection antii-oxidant 24h-moisture creme broad spectrum spf 15 normal/combination skin avobenzone and octisalate water dimethicone butyloctyl salicylate butylene glycol polyester-8 (1400 mw, cyanodiphenylpropenoyl capped) cetyl ricinoleate steareth-21 steareth-2 di-c12-15 alkyl fumarate caprylic/capric/palmitic/stearic triglyceride guava gentiana lutea root reynoutria japonica root stearyl alcohol barley laminaria ochroleuca rosemary wheat germ fumaria officinalis flowering top caffeine pentylene glycol rice germ vitis vinifera seed lauryl peg-9 polydimethylsiloxyethyl dimethicone thermus thermophilus lysate docosanol tricontanyl povidone glycerin alkyl (c12-15) benzoate linoleic acid cholesterol squalane sodium pyrrolidone carboxylate 1,2-hexanediol urea medium-chain triglycerides dipropylene glycol dibenzoate .alpha.-tocopherol acetate tetrahexyldecyl ascorbate hyaluronate sodium ergothioneine isohexadecane ppg-15 stearyl ether benzoate enoxolone trehalose polysorbate 80 hydrogenated soybean lecithin caprylyl glycol sodium hydroxide sodium chloride ascorbyl tocopheryl maleate citric acid monohydrate ethylbisiminomethylguaiacol manganese chloride pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) edetate disodium anhydrous butylated hydroxytoluene sodium dehydroacetate phenoxyethanol fd&c blue no. 1 fd&c yellow no. 5 chromium hydroxide green chlorphenesin triacetin nordihydroguaiaretic acid, (+/-)- .beta.-cyclodextrin sulfobutyl ether trimethylpentanediol/adipic acid/glycerin crosspolymer (25000 mpa.s) glucose 1,6-bisphosphate lecithin, soybean potassium sorbate polyquaternium-51 (2-methacryloyloxyethyl phosphorylcholine/n-butyl methacrylate; 3:7) acrylamide acrylic acid rice bran avobenzone avobenzone octisalate octisalate
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
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 out of reach of children. if product is swallowed, get medical help or contact a poison control center right away.
Do Not Use:
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 out of reach of children. if product is swallowed, get medical help or contact a poison control center right away.
When Using:
When using this product keep out of eyes. rinse with water to remove.
Dosage and Administration:
Directions for sunscreen use: apply liberally and evenly 15 minutes before sun exposure reapply at least every two hours use a water resistant sunscreen if swimming or sweating 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. â 2 p.m. wear long-sleeved shirts, pants, hats and sunglasses children under 6 months of age: ask a doctor
Stop Use:
Stop use and ask a doctor if rash occurs
Package Label Principal Display Panel:
Principal display panel - 50 ml jar carton estÄe lauder daywear multi-protection anti-oxidant 24h-moisture creme broad spectrum spf 15 normal/combination skin poids net wt. 1.7 oz. / 50 ml e principal display panel