NDC 49527-075 Superdefense Broad Spectrum Spf 25 Fatigue Plus 1st Signs Of Age Multi-correcting

Avobenzone And Octisalate

NDC Product Code 49527-075

NDC CODE: 49527-075

Proprietary Name: Superdefense Broad Spectrum Spf 25 Fatigue Plus 1st Signs Of Age Multi-correcting 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 And Octisalate 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

  • 49527 - Clinique Laboratories Llc
    • 49527-075 - Superdefense Broad Spectrum Spf 25 Fatigue Plus 1st Signs Of Age Multi-correcting

NDC 49527-075-01

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

NDC Product Information

Superdefense Broad Spectrum Spf 25 Fatigue Plus 1st Signs Of Age Multi-correcting with NDC 49527-075 is a a human over the counter drug product labeled by Clinique Laboratories Llc. The generic name of Superdefense Broad Spectrum Spf 25 Fatigue Plus 1st Signs Of Age Multi-correcting is avobenzone and octisalate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Clinique Laboratories Llc

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.

Superdefense Broad Spectrum Spf 25 Fatigue Plus 1st Signs Of Age Multi-correcting 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.

  • AVOBENZONE .0306 g/mL
  • OCTISALATE .051 g/mL

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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
  • POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • BRUSSELS SPROUT (UNII: KHX46H31F8)
  • LOWBUSH BLUEBERRY (UNII: G90PX41VP0)
  • BROCCOLI (UNII: UOI4FT57BZ)
  • CARROT (UNII: L56Z1JK48B)
  • KALE (UNII: 0Y3L4J38H1)
  • SPINACH (UNII: 6WO75C6WVB)
  • RESVERATROL (UNII: Q369O8926L)
  • RICE BRAN (UNII: R60QEP13IC)
  • CRANBERRY (UNII: 0MVO31Q3QS)
  • CUCUMBER (UNII: YY7C30VXJT)
  • ADENOSINE PHOSPHATE (UNII: 415SHH325A)
  • SALICYLIC ACID (UNII: O414PZ4LPZ)
  • SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
  • CREATINE (UNII: MU72812GK0)
  • ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)
  • LACTOBACILLUS REUTERI (UNII: 9913I24QEE)
  • ERGOTHIONEINE (UNII: BDZ3DQM98W)
  • BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
  • ACETYLCARNITINE HYDROCHLORIDE (UNII: NDW10MX58T)
  • CAFFEINE (UNII: 3G6A5W338E)
  • BARLEY (UNII: 5PWM7YLI7R)
  • ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • 7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)
  • ISOHEXADECANE (UNII: 918X1OUF1E)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • TREHALOSE (UNII: B8WCK70T7I)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY)
  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
  • HELIANTHUS ANNUUS SEEDCAKE (UNII: 482WYF7XLC)
  • YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
  • CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)
  • PEG-8 LAURATE (UNII: 762O8IWA10)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • FYTIC ACID (UNII: 7IGF0S7R8I)
  • PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)
  • TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
  • PROPYLENE GLYCOL CAPRYLATE (UNII: RT9P9S09QI)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • MICA (UNII: V8A1AW0880)

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.
  • 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: Clinique Laboratories Llc
Labeler Code: 49527
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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 11-21-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

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Superdefense Broad Spectrum Spf 25 Fatigue Plus 1st Signs Of Age Multi-correcting Product Label Images

Superdefense Broad Spectrum Spf 25 Fatigue Plus 1st Signs Of Age Multi-correcting 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

Other

Drug Facts

Active Ingredients

Avobenzone 3.0% Octisalate 5.0%

Purpose

Sunscreen

Use

Helps prevent sunburn

Warnings

For external use only

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 - Stop Use

Stop use and ask a doctor if rash occurs

Otc - Keep Out Of Reach Of Children

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

Directions

  • For sunscreen use:apply liberally 15 minutes before sun exposurereapply at least every two hoursuse a water resistant sunscreen if swimming or sweatingSun 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 sunglasseschildren under 6 months of age: ask a doctor

Inactive Ingredients

Water\aqua\eau • glycerin • neopentyl glycol diheptanoate • polyester-8 • dimethicone • sorbitan stearate • butyloctyl salicylate • polysorbate 60 • butylene glycol • sodium acrylates copolymer • silica • cetyl alcohol • niacinamide • pentylene glycol • brassica oleracea gemmifera (brussels sprouts) extract • vaccinium angustifolium (blueberry) fruit extract • brassica oleracea italica (broccoli) extract • daucus carota sativa (carrot) root extract • brassica oleracea acephala (kale) leaf extract • spinacia oleracea (spinach) leaf extract • resveratrol • plankton extract • oryza sativa (rice) bran extract • vaccinium macrocarpon (cranberry) fruit extract • cucumis sativus (cucumber) fruit extract • adenosine phosphate • salicylic acid • laminaria saccharina extract • creatine • arabidopsis thaliana extract • lactobacillus ferment • ergothioneine • micrococcus lysate • biosaccharide gum-4 • algae extract • acetyl carnitine hcl • caffeine • hordeum vulgare (barley) extract\extrait d'orge • albizia julibrissin bark extract • sigesbeckia orientalis (st. paul's wort) extract • sodium rna • sodium hyaluronate • 7-dehydrocholesterol • styrene/acrylates copolymer • isohexadecane • tocopheryl acetate • peg-100 stearate • trehalose • ethylhexylglycerin • lecithin • propylene glycol dicaprate • polyethylene • helianthus annuus (sunflower) seedcake • yeast extract\faex\extrait de levure • capryloyl glycine • peg-8 laurate • polysorbate 80 • acrylamide/sodium acryloyldimethyltaurate copolymer • phytic acid • sea whip extract • tetrahexyldecyl ascorbate • propylene glycol caprylate • disodium edta • bht • chlorphenesin • phenoxyethanol • titanium dioxide (ci 77891) • mica [iln44660]

Other Information

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