NDC 65966-021 La Mer The Radiant Skintint Broad Spectrum Spf 30

Octinoxate, Octisalate, And Titanium Dioxide

NDC Product Code 65966-021

NDC CODE: 65966-021

Proprietary Name: La Mer The Radiant Skintint Broad Spectrum Spf 30 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: Octinoxate, Octisalate, And Titanium Dioxide 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

  • 65966 - Max Huber Research Lab Inc
    • 65966-021 - La Mer The Radiant Skintint Broad Spectrum Spf 30

NDC 65966-021-01

Package Description: 1 TUBE in 1 CARTON > 40 mL in 1 TUBE

NDC Product Information

La Mer The Radiant Skintint Broad Spectrum Spf 30 with NDC 65966-021 is a a human over the counter drug product labeled by Max Huber Research Lab Inc. The generic name of La Mer The Radiant Skintint Broad Spectrum Spf 30 is octinoxate, octisalate, and titanium dioxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Max Huber Research Lab Inc

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.

La Mer The Radiant Skintint Broad Spectrum Spf 30 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.

  • OCTINOXATE 82.5 mg/mL
  • OCTISALATE 22 mg/mL
  • TITANIUM DIOXIDE 58.3 mg/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)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • LAURETH-4 (UNII: 6HQ855798J)
  • ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
  • NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
  • NORI (UNII: 477TV3P5UX)
  • SESAME OIL (UNII: QX10HYY4QV)
  • ALFALFA SEED (UNII: 67PHZ58858)
  • HELIANTHUS ANNUUS SEEDCAKE (UNII: 482WYF7XLC)
  • EUCALYPTUS GUM (UNII: 72T9EZC2VX)
  • SODIUM GLUCONATE (UNII: R6Q3791S76)
  • COPPER GLUCONATE (UNII: RV823G6G67)
  • CALCIUM GLUCONATE (UNII: SQE6VB453K)
  • MAGNESIUM GLUCONATE (UNII: T42NAD2KHC)
  • ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
  • .ALPHA.-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE)
  • NIACIN (UNII: 2679MF687A)
  • SESAME SEED (UNII: 7Y1255HVXR)
  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
  • GAMOCHAETA PURPUREA FLOWER (UNII: KQV867ADR4)
  • CUCUMBER (UNII: YY7C30VXJT)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
  • CORALLINA OFFICINALIS (UNII: 4004498D06)
  • PLOCAMIUM CARTILAGINEUM (UNII: 37LBZ0E1UE)
  • SACCHAROMYCES LYSATE (UNII: R85W246Z1C)
  • SPEARMINT (UNII: J7I2T6IV1N)
  • PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
  • SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
  • CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)
  • LAMINARIA DIGITATA (UNII: 15E7C67EE8)
  • METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)
  • ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
  • SUCROSE (UNII: C151H8M554)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ENOXOLONE (UNII: P540XA09DR)
  • CAFFEINE (UNII: 3G6A5W338E)
  • PROPYLENE GLYCOL DIETHYLHEXANOATE (UNII: 8D8I9Z0F1Z)
  • ISOHEXADECANE (UNII: 918X1OUF1E)
  • DIMETHOXYTOLYL PROPYLRESORCINOL (UNII: 4OD5GIH1UK)
  • LIME PEEL (UNII: 544EQK5Q0W)
  • N-ACETYLGLUCOSAMINE (UNII: V956696549)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • ROSA X DAMASCENA FLOWER OIL (UNII: 18920M3T13)
  • YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
  • ISOSTEARIC ACID (UNII: X33R8U0062)
  • PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY)
  • BARLEY (UNII: 5PWM7YLI7R)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TROMETHAMINE (UNII: 023C2WHX2V)
  • GALACTOARABINAN (UNII: SL4SX1O487)
  • NYLON-12 (UNII: 446U8J075B)
  • ZEOLITE A (UNII: Y3NG9WF08W)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • BORON NITRIDE (UNII: 2U4T60A6YD)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • ALCOHOL (UNII: 3K9958V90M)
  • STANNIC OXIDE (UNII: KM7N50LOS6)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • GERANIOL (UNII: L837108USY)
  • .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • 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: Max Huber Research Lab Inc
Labeler Code: 65966
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: 02-26-2020 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’.

* Please review the disclaimer below.

La Mer The Radiant Skintint Broad Spectrum Spf 30 Product Label Images

La Mer The Radiant Skintint Broad Spectrum Spf 30 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

OCTINOXATE 7.5%OCTISALATE 2.0%TITANIUM DIOXIDE 5.3%

Purpose

SUNSCREEN

Uses

  • Helps prevent sunburnif 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

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 • BUTYLENE GLYCOL • OCTYLDODECYL NEOPENTANOATE • CETYL ALCOHOL • LAURETH-4 • ASCORBYL GLUCOSIDE • NEOPENTYL GLYCOL DIHEPTANOATE • ALGAE (SEAWEED) EXTRACT • SESAMUM INDICUM (SESAME) SEED OIL • MEDICAGO SATIVA (ALFALFA) SEED POWDER • HELIANTHUS ANNUUS (SUNFLOWER) SEEDCAKE • PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) SEED MEAL • EUCALYPTUS GLOBULUS (EUCALYPTUS) LEAF OIL • SODIUM GLUCONATE • COPPER GLUCONATE • CALCIUM GLUCONATE • MAGNESIUM GLUCONATE • ZINC GLUCONATE • TOCOPHERYL SUCCINATE • NIACIN • SESAMUM INDICUM (SESAME) SEED POWDER • POLYETHYLENE • HELICHRYSUM ARENARIUM (EVERLASTING) EXTRACT • CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT • PEG-100 STEARATE • HYDROGENATED LECITHIN • CORALLINA OFFICINALIS EXTRACT • GELIDIUM CARTILAGINEUM EXTRACT • SACCHAROMYCES LYSATE EXTRACT • MENTHA VIRIDIS (SPEARMINT) • PELARGONIUM GRAVEOLENS (GERANIUM) FLOWER OIL • LAMINARIA SACCHARINA EXTRACT • CITRUS GRANDIS (GRAPEFRUIT) PEEL OIL • LAMINARIA DIGITATA EXTRACT • METHYLDIHYDROJASMONATE • SIGESBECKIA ORIENTALIS (ST. PAUL'S WORT) EXTRACT • ACETYL HEXAPEPTIDE-8 • SUCROSE • GLYCERIN • GLYCYRRHETINIC ACID • CAFFEINE • PROPYLENE GLYCOL DIETHYLHEXANOATE • LECITHIN • ISOHEXADECANE • POLYGLYCERYL-3 BEESWAX • WHEY PROTEIN\LACTIS PROTEIN\PROTEINE DU PETIT-LAIT • DIMETHOXYTOLYL PROPYLRESORCINOL • CITRUS AURANTIFOLIA (LIME) PEEL EXTRACT • ACETYL GLUCOSAMINE • PVP/HEXADECENE COPOLYMER • TOURMALINE • YEAST POLYSACCHARIDES • CAPRYLYL GLYCOL • ROSA DAMASCENA (ROSE) FLOWER OIL • YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE • ISOSTEARIC ACID • PROPYLENE GLYCOL DICAPRATE • HORDEUM VULGARE (BARLEY) EXTRACT\EXTRAIT D'ORGE • STEARIC ACID • TROMETHAMINE • ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER • GALACTOARABINAN • NYLON-12 • ZEOLITE • SYNTHETIC FLUORPHLOGOPITE • TOCOPHERYL LINOLEATE/OLEATE • SODIUM HYALURONATE • BORON NITRIDE • XANTHAN GUM • POLYSORBATE 80 • SILICA • ALUMINUM HYDROXIDE • ALCOHOL DENAT. • TIN OXIDE • DISODIUM EDTA • BHT • LINALOOL • GERANIOL • CITRONELLOL • LIMONENE • PHENOXYETHANOL • [+/- TITANIUM DIOXIDE (CI 77891) • IRON OXIDES (CI 77491) • IRON OXIDES (CI 77492) • IRON OXIDES (CI 77499) • MICA]

Other Information

  • Protect the product in this container from excessive heat and direct sun

* Please review the disclaimer below.