FUTURIST HYDRA RESCUE MOISTURIZING MAKEUP BROAD SPECTRUM SPF 45: Package Insert and Label Information

FUTURIST HYDRA RESCUE MOISTURIZING MAKEUP BROAD SPECTRUM SPF 45- ensulizole, octinoxate, octisalate and zinc oxide liquid
ESTEE LAUDER INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredients Purpose
Ensulizole 2.7% Sunscreen
Octinoxate 6.7% Sunscreen
Octisalate 4.5% Sunscreen
Zinc Oxide 3.8% Sunscreen

Use

helps prevent sunburn

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.

Directions

For sunscreen use:

  • apply liberally 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. – 2 p.m.
    • wear long-sleeved shirts, pants, hats and sunglasses
  • children 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)] <iln47153>

Other information

protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL — 35 ml Tube Carton

ESTĒE LAUDER

Futurist
Hydra Rescue
Moisturizing Makeup
Broad Spectrum
SPF 45

1.2 FL. OZ. LIQ.
35ml e

PRINCIPAL DISPLAY PANEL -- 35 ml Tube Carton
(click image for full-size original)
FUTURIST HYDRA RESCUE MOISTURIZING MAKEUP BROAD SPECTRUM SPF 45
ensulizole, octinoxate, octisalate, and zinc oxide liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11559-058
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENSULIZOLE (ENSULIZOLE) ENSULIZOLE 0.0324 g in 1 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE 0.0804 g in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE 0.054 g in 1 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 0.0456 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
DIMETHICONE
PHENYL TRIMETHICONE
BUTYLENE GLYCOL
GLYCERIN
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
TROMETHAMINE
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
HEXYL LAURATE
LIMOSILACTOBACILLUS REUTERI
CUCUMBER
HYALURONATE SODIUM
CHIA SEED
SELENICEREUS UNDATUS FRUIT
HELIANTHUS ANNUUS SEEDCAKE
ACAI OIL
CARAPA GUIANENSIS SEED OIL
CAFFEINE
TREMELLA FUCIFORMIS FRUITING BODY
CAMELINA SATIVA SEED OIL
SAPINDUS MUKOROSSI FRUIT
CAESALPINIA SPINOSA RESIN
COPAIFERA OFFICINALIS RESIN
MEDIUM-CHAIN TRIGLYCERIDES
PROPYLENE GLYCOL DICAPRATE
N-ACETYLGLUCOSAMINE
.ALPHA.-TOCOPHEROL ACETATE
ACETYL HEXAPEPTIDE-8
TREHALOSE
DISTEARDIMONIUM HECTORITE
HYDROXYETHYL UREA
NEOPENTYL GLYCOL DIHEPTANOATE
HYDROGENATED COCO-GLYCERIDES
LECITHIN, SOYBEAN
POLYGLYCERYL-4 ISOSTEARATE
GLYCERYL MONOSTEARATE
TRIETHOXYCAPRYLYLSILANE
TRIETHYL CITRATE
LAURETH-7
LINOLEIC ACID
METHICONE (20 CST)
STEARYL ALCOHOL
CETOSTEARYL ALCOHOL
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S)
SILICON DIOXIDE
BARLEY
TOCOPHEROL
PALMITIC ACID
STEARIC ACID
OLEIC ACID
SODIUM CHLORIDE
POLYSORBATE 80
POLYSORBATE 20
DOCOSANOL
GLYCERYL TRIOLEATE
BETAINE
EDETATE DISODIUM ANHYDROUS
BUTYLATED HYDROXYTOLUENE
PHENOXYETHANOL
SODIUM DEHYDROACETATE
POTASSIUM SORBATE
MICA
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
TITANIUM DIOXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11559-058-01 1 TUBE in 1 CARTON contains a TUBE
1 35 mL in 1 TUBE This package is contained within the CARTON (11559-058-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final M020 10/04/2019
Labeler — ESTEE LAUDER INC (005914387)
Registrant — Estee Lauder Companies Inc. (790802086)
Establishment
Name Address ID/FEI Operations
Len-Ron Manufacturing Division of Aramis Inc. 809771152 manufacture (11559-058), pack (11559-058), label (11559-058)
Establishment
Name Address ID/FEI Operations
Estee Lauder Cosmetics Ltd. 202952982 manufacture (11559-058), pack (11559-058), label (11559-058)
Establishment
Name Address ID/FEI Operations
Whitman Laboratories Ltd. 216866277 manufacture (11559-058), pack (11559-058), label (11559-058)
Establishment
Name Address ID/FEI Operations
Estee Lauder N.V. 370151326 manufacture (11559-058), pack (11559-058), label (11559-058)
Establishment
Name Address ID/FEI Operations
PALC 078364654 pack (11559-058), label (11559-058)
Establishment
Name Address ID/FEI Operations
Estee Lauder Cosmetics Ltd. 204132062 pack (11559-058), label (11559-058)
Establishment
Name Address ID/FEI Operations
Northtec LLC 943871157 pack (11559-058), label (11559-058)
Establishment
Name Address ID/FEI Operations
PADC 1 949264774 pack (11559-058), label (11559-058)

Revised: 08/2022 ESTEE LAUDER INC

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