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

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