NDC 11559-058 Futurist Hydra Rescue Moisturizing Makeup Broad Spectrum Spf 45

Ensulizole, Octinoxate, Octisalate, And Zinc Oxide

NDC Product Code 11559-058

NDC 11559-058-01

Package Description: 1 TUBE in 1 CARTON > 35 mL in 1 TUBE

NDC Product Information

Futurist Hydra Rescue Moisturizing Makeup Broad Spectrum Spf 45 with NDC 11559-058 is a a human over the counter drug product labeled by Estee Lauder Inc. The generic name of Futurist Hydra Rescue Moisturizing Makeup Broad Spectrum Spf 45 is ensulizole, octinoxate, octisalate, and zinc oxide. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Estee Lauder Inc

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.

Futurist Hydra Rescue Moisturizing Makeup Broad Spectrum Spf 45 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.

  • ENSULIZOLE .0324 g/mL
  • OCTINOXATE .0804 g/mL
  • OCTISALATE .054 g/mL
  • ZINC OXIDE .0456 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)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
  • LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
  • TROMETHAMINE (UNII: 023C2WHX2V)
  • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
  • HEXYL LAURATE (UNII: 4CG9F9W01Q)
  • LACTOBACILLUS REUTERI (UNII: 9913I24QEE)
  • CUCUMBER (UNII: YY7C30VXJT)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • CHIA SEED (UNII: NU0OLX06F8)
  • HYLOCEREUS UNDATUS FRUIT (UNII: WUG58TD53X)
  • HELIANTHUS ANNUUS SEEDCAKE (UNII: 482WYF7XLC)
  • ACAI OIL (UNII: Z0W6766A2W)
  • CARAPA GUIANENSIS SEED OIL (UNII: Y82418EH2I)
  • CAFFEINE (UNII: 3G6A5W338E)
  • TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)
  • CAMELINA SATIVA SEED OIL (UNII: 12824X01L0)
  • SAPINDUS MUKOROSSI FRUIT (UNII: 66H9NW427Y)
  • CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)
  • COPAIFERA OFFICINALIS RESIN (UNII: 1VH544O5AT)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY)
  • N-ACETYLGLUCOSAMINE (UNII: V956696549)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
  • TREHALOSE (UNII: B8WCK70T7I)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
  • NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
  • HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
  • LAURETH-7 (UNII: Z95S6G8201)
  • LINOLEIC ACID (UNII: 9KJL21T0QJ)
  • METHICONE (20 CST) (UNII: 6777U11MKT)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • BARLEY (UNII: 5PWM7YLI7R)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • PALMITIC ACID (UNII: 2V16EO95H1)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • OLEIC ACID (UNII: 2UMI9U37CP)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • DOCOSANOL (UNII: 9G1OE216XY)
  • GLYCERYL TRIOLEATE (UNII: O05EC62663)
  • BETAINE (UNII: 3SCV180C9W)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • MICA (UNII: V8A1AW0880)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: Estee Lauder Inc
Labeler Code: 11559
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: 10-04-2019 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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Futurist Hydra Rescue Moisturizing Makeup Broad Spectrum Spf 45 Product Label Images

Futurist Hydra Rescue Moisturizing Makeup Broad Spectrum Spf 45 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

Otc - Purpose

Active ingredientsPurposeEnsulizole 2.7%SunscreenOctinoxate 6.7%SunscreenOctisalate 4.5%SunscreenZinc Oxide 3.8%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 • dimethicone • phenyl trimethicone • butylene glycol • glycerin • polymethylsilsesquioxane • lauryl peg-9 polydimethylsiloxyethyl dimethicone • hdi/ppg/polycaprolactone crosspolymer • trimethylsiloxysilicate/dimethiconol crosspolymer • tromethamine • polysilicone-11 • hexyl laurate • cetyl peg/ppg-10/1 dimethicone • lactobacillus ferment • cucumis sativus (cucumber) fruit extract • sodium hyaluronate • salvia hispanica seed extract • hylocereus undatus fruit extract • helianthus annuus (sunflower) seedcake • algae extract • euterpe oleracea fruit oil • carapa guaianensis seed oil • caffeine • jojoba esters • tremella fuciformis sporocarp extract • camelina sativa seed oil • sapindus mukorossi fruit extract • caesalpinia spinosa gum • copaifera officinalis (balsam copaiba) resin • caprylic/capric triglyceride • propylene glycol dicaprate • acetyl glucosamine • tocopheryl acetate • acetyl hexapeptide-8 • lecithin • trehalose • disteardimonium hectorite • hydroxyethyl urea • neopentyl glycol diheptanoate • dimethicone/divinyldimethicone silsesquioxane crosspolymer • hydrogenated coco-glycerides • phospholipids • trimethylsiloxysilicate • polyhydroxystearic acid • polyglyceryl-4 isostearate • glyceryl stearate • triethoxycaprylylsilane • triethyl citrate • laureth-7 • linoleic acid • methicone • stearyl alcohol • cetearyl alcohol • ammonium polyacryloyldimethyl taurate • silica • hordeum vulgare (barley) extract\extrait d'orge • tocopherol • palmitic acid • phytosteryl canola glycerides • stearic acid • oleic acid • sodium chloride • polysorbate 80 • polysorbate 20 • behenyl alcohol • triolein • betaine • fragrance (parfum) • disodium edta • bht • phenoxyethanol • sodium dehydroacetate • potassium sorbate • [+/- mica • iron oxides (ci 77491) • iron oxides (ci 77492) • iron oxides (ci 77499) • titanium dioxide (ci 77891)]

Other Information

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