NDC 49527-080 Clinique Even Better Clinical Serum Foundation Broad Spectrum Spf 25

Titanium Dioxide And Zinc Oxide

NDC Product Code 49527-080

NDC 49527-080-01

Package Description: 1 BOTTLE in 1 CARTON > 3 g in 1 BOTTLE

NDC Product Information

Clinique Even Better Clinical Serum Foundation Broad Spectrum Spf 25 with NDC 49527-080 is a a human over the counter drug product labeled by Clinique Laboratories Llc. The generic name of Clinique Even Better Clinical Serum Foundation Broad Spectrum Spf 25 is titanium dioxide and zinc oxide. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Clinique Laboratories Llc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Clinique Even Better Clinical Serum Foundation Broad Spectrum Spf 25 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.

  • TITANIUM DIOXIDE 24 mg/g
  • ZINC OXIDE 59 mg/g

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.

  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • WATER (UNII: 059QF0KO0R)
  • DIMETHICONE PEG-10 PHOSPHATE (UNII: O7Q5NJ7X88)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
  • PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
  • ISODODECANE (UNII: A8289P68Y2)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • ISODECYL ISONONANOATE (UNII: 4X46Q4U00Z)
  • LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
  • ALCOHOL (UNII: 3K9958V90M)
  • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
  • TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
  • MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
  • POLYGALA SENEGA ROOT (UNII: M7T6H7D4IF)
  • BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U)
  • NYMPHAEA ALBA ROOT (UNII: 866B05KWBR)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • CHIA SEED (UNII: NU0OLX06F8)
  • MOLASSES (UNII: LSU3YX0KZO)
  • DIMETHOXYTOLYL PROPYLRESORCINOL (UNII: 4OD5GIH1UK)
  • CAFFEINE (UNII: 3G6A5W338E)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • SALICYLIC ACID (UNII: O414PZ4LPZ)
  • LINOLEIC ACID (UNII: 9KJL21T0QJ)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • MYELOPEROXIDASE (UNII: JQZ6YM58U5)
  • GLUCOSE OXIDASE (UNII: 0T8392U5N1)
  • LACTOBACILLUS REUTERI (UNII: 9913I24QEE)
  • ENOXOLONE (UNII: P540XA09DR)
  • CHOLESTEROL (UNII: 97C5T2UQ7J)
  • HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
  • ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
  • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
  • LAURETH-7 (UNII: Z95S6G8201)
  • TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
  • SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
  • EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • DIMETHICONE PEG-15 ACETATE (UNII: 11034H9BGQ)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • PROPYLENE CARBONATE (UNII: 8D08K3S51E)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • MICA (UNII: V8A1AW0880)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)

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: 09-24-2020 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: 12-31-2021 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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Clinique Even Better Clinical Serum Foundation Broad Spectrum Spf 25 Product Label Images

Clinique Even Better Clinical Serum Foundation Broad Spectrum Spf 25 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

Titanium Dioxide 2.4%Zinc Oxide 5.9%

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

Dimethicone•water\aqua\eau•peg-10 dimethicone•butylene glycol•vinyl dimethicone/methicone silsesquioxane crosspolymer•phenyl trimethicone• isododecane•butyloctyl salicylate•isodecyl isononanoate•lauryl peg-9 polydimethylsiloxyethyl dimethicone•alcohol denat.•dimethicone/vinyl dimethicone crosspolymer•hydrated silica•ascorbyl glucoside•tetrahexyldecyl ascorbate•magnesium ascorbyl phosphate•sodium hyaluronate•tocopheryl acetate•laminaria saccharina extract•polygala senega root extract•berberis vulgaris extract•nymphaea alba root extract•camellia sinensis leaf extract•salvia hispanica seed extract•molasses extract\saccharum officinarum\extrait de mélasse•dimethoxytolyl propylresorcinol•caffeine•niacinamide•salicylic acid• linoleic acid•tocopherol•lactoperoxidase•glucose oxidase•lactobacillus ferment•glycyrrhetinic acid• cholesterol•jojoba esters•glucose•polysilicone-11• laureth-7•trimethylsiloxysilicate•sorbitan sesquioleate•lecithin•xanthan gum•silica•caprylyl glycol•dimethicone/peg-10/15 crosspolymer• disteardimonium hectorite•triethoxycaprylylsilane• alumina•propylene carbonate•dipropylene glycol• sodium chloride•sodium hydroxide•citric acid• potassium phosphate•tetrasodium edta•sodium citrate•potassium sorbate•phenoxyethanol•[+/-mica•titanium dioxide (ci 77891)•iron oxides (ci 77491)•iron oxides (ci 77492)•iron oxides (ci 77499)] [iln47715]

Other Information

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